more than 900 medicines and vaccines in against...

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Few things cause more fear and apprehension than a cancer diagnosis. But today—because of early detection and a steady stream of new and improved treatments—cancer increasingly can be managed and even beaten. But patients and their families are looking for more and bet- ter treatments, and America’s biopharmaceuti- cal research companies are responding. Biopharmaceutical researchers are now work- ing on 981 medicines for cancer. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways. Researchers’ deep commitment to patients and advancing science is at the core of the remark- able progress made in fighting cancer. In re- cent years we have seen significant declines in cancer deaths. The number of cancer survivors living in the United States has increased from 3 million in 1971 to nearly 12 million in 2008. The increase in survivors is attributed in large measure to earlier diagnosis and detection and better treatments and follow-up care. America’s biopharmaceutical research com- panies are working on many new cutting-edge approaches to fight cancer. They include: A medicine that interferes with the me- tabolism of cancer cells by depriving them of the energy provided by glucose. A medicine for acute myeloid leukemia (AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers. A therapy that uses nanotechnology to target the delivery of medicines to cancer cells, potentially overcoming some limita- tions of existing treatments. Despite recent progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart disease. In 2012, some 577,190 Americans are expected to die of cancer—more than 1,500 people a day. The hundreds of new medicines to treat cancer now being developed are our best hope for lessening the burden of cancer to patients, their families and society. More Than 900 Medicines and Vaccines in Clinical Testing Offer New Hope in the Fight Against Cancer Medicines in Development CANCER PRESENTED BY AMERICAS BIOPHARMACEUTICAL RESEARCH COMPANIES 2012 REPORT 111 66 121 117 94 Lymphoma Colorectal Cancer Lung Cancer Prostate Cancer Breast Cancer 67 Skin Cancer Medicines in Development for Selected Cancer Types More Than 1.6 million New Cases of Cancer Are Expected This Year

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  • Few things cause more fear and apprehension than a cancer diagnosis. But today—because of early detection and a steady stream of new and improved treatments—cancer increasingly can be managed and even beaten. But patients and their families are looking for more and bet-ter treatments, and America’s biopharmaceuti-cal research companies are responding.

    Biopharmaceutical researchers are now work-ing on 981 medicines for cancer. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways.

    Researchers’ deep commitment to patients and advancing science is at the core of the remark-able progress made in fighting cancer. In re-cent years we have seen significant declines in cancer deaths. The number of cancer survivors living in the United States has increased from 3 million in 1971 to nearly 12 million in 2008. The increase in survivors is attributed in large measure to earlier diagnosis and detection and better treatments and follow-up care.

    America’s biopharmaceutical research com-panies are working on many new cutting-edge

    approaches to fight cancer. They include:

    • A medicine that interferes with the me-tabolism of cancer cells by depriving them of the energy provided by glucose.

    • A medicine for acute myeloid leukemia (AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers.

    • A therapy that uses nanotechnology to target the delivery of medicines to cancer cells, potentially overcoming some limita-tions of existing treatments.

    Despite recent progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart disease. In 2012, some 577,190 Americans are expected to die of cancer—more than 1,500 people a day. The hundreds of new medicines to treat cancer now being developed are our best hope for lessening the burden of cancer to patients, their families and society.

    More Than 900 Medicines and Vaccines in Clinical Testing Offer New Hope in the Fight Against Cancer

    Medicines in Development

    CanCerpresented by america’s biopharmaceutical research companies

    2012 RepoRt

    111

    66

    121117

    94

    Lym

    phom

    a

    Col

    orec

    tal C

    ance

    rLu

    ng C

    ance

    r

    Pros

    tate

    Can

    cer

    Brea

    st C

    ance

    r

    67

    Skin

    Can

    cer

    Medicines in Development

    for Selected Cancer Types

    More Than

    1.6 million New Cases of Cancer Are Expected This Year

  • Medicines in Development Cancer 20122

    **For more information about a specific medicine in this report, please call the telephone number listed.

    Lung Cancer

    Liver Cancer

    Leukemia

    Kidney Cancer

    Head/Neck Cancer

    Colorectal Cancer

    Cervical Cancer

    Breast Cancer

    Brain Cancer

    Bladder Cancer 9

    62

    66

    111

    8

    25

    35

    120

    36

    121

    Multiple Myeloma

    Lymphoma 117

    57

    Ovarian Cancer 63

    Cancer-Related Conditions

    Stomach Cancer

    Solid Tumors

    Skin Cancer

    Sarcoma

    Prostate Cancer

    Pancreatic Cancer

    94

    58

    21

    67

    280

    23

    38

    Unspecified Cancer

    Other Cancers 102

    72

    * Some medicines are listed in more than one category.

    Medicines in Development for Cancer*

    Medicines in Development for Cancer

    Bladder CanCer

    product Name Sponsor Indication Development Status*

    Abraxane®albumin-bound paclitaxel

    CelgeneSummit, NJ

    second-line bladder cancer (see also breast, lung, ovarian, pancreatic, skin)

    Phase II(908) 673-9000

    AEZS-108 AEterna ZentarisBasking Ridge, NJ

    (see also ovarian, prostate, other) Phase II(908) 626-5428

    BC-819 (gene therapy)

    BioCancell TherapeuticsJerusalem, Israel

    (see also ovarian, pancreatic) Phase IIwww.biocancell.com

    EN3488(mycobacterium cell wall-DNA complex)

    Endo PharmaceuticalsChadds Ford, PA

    non-muscle invasive bladder cancer(Fast Track)

    Phase III(610) 558-9800

  • Medicines in Development Cancer 2012 3

    Bladder CanCe

    product Name Sponsor Indication Development Status

    eoquin®apaziquone

    AllerganIrvine, CASpectrum PharmaceuticalsIrvine, CA

    non-invasive bladder cancer(Fast Track)

    Phase III(949) 788-6700

    Folotyn®pralatrexate(orphan Drug)

    Allos TherapeuticsWestminster, CO

    (see also breast, lung, lymphoma) Phase II(303) 426-6262

    icrucumab(LY3012212/IMC-18F1)

    Eli LillyIndianapolis, INImCloneBridgewater, NJ

    (see also breast, colorectal) Phase II(800) 545-5979

    tesetaxel GentaBerkeley Heights, NJ

    second-line bladder cancer (see also breast, prostate, skin, stomach)

    Phase II(908) 286-9800

    VB4-845 Viventia BiotechnologiesMississauga, Canada

    (see also head/neck) Phase II(905) 362-2973

    Brain CanCer

    product Name Sponsor Indication Development Status

    8H9 I-131 mAb United TherapeuticsSilver Spring, MD

    (see also sarcoma, other) Phase I(301) 608-9292

    ABT-888(veliparib)(PARP inhibitor)

    Abbott LaboratoriesAbbott Park, IL

    (see also breast, colorectal, lung, lymphoma, ovarian, prostate, skin, other)

    Phase I(847) 937-6100

    AC480(pan-HER inhibitor)

    Ambit BiosciencesSan Diego, CA

    glioma(see also breast, lung)

    Phase I(858) 334-2100

    AEE788 Novartis PharmaceuticalsEast Hanover, NJ

    glioblastoma Phase I/II(888) 669-6682

    afatinib(BIBW2992)

    Boehringer IngelheimPharmaceuticalsRidgefield, CT

    glioblastoma(see also breast, head/neck, lung)

    Phase I/II(800) 243-0127

    APN301(ch14.18 mAb/interleukin-2 fusion protein)

    Apeiron BiologicsVienna, Austria

    neuroblastoma in children(see also skin)

    Phase II completedwww.apeiron-biologics.com

    Medicines in Development for Cancer

  • Medicines in Development Cancer 20124

    Brain CanCer

    product Name Sponsor Indication Development Status

    AR-67 Arno TherapeuticsFlemington, NJ

    glioblastoma(see also leukemia, solid tumors)

    Phase II(862) 703-7170

    ARC-100 Archer BiosciencesNew York, NY

    glioblastoma (recurrent)(see also breast, prostate, skin)--------------------------------------------------neuroblastoma (combination therapy)--------------------------------------------------medulloblastoma (combination therapy)

    Phase II(646) 747-9090-------------------------------------------Phase I/II(646) 747-9090-------------------------------------------Phase I(646) 747-9090

    AT-101(oral pan Bcl-2 inhibitor)

    Ascenta TherapeuticsMalvern, PA

    glioblastoma(see also leukemia, lung, lymphoma, prostate, stomach)

    Phase II(610) 408-0301

    Avastin®bevacizumab

    GenentechSouth San Francisco, CA

    first-line glioblastoma multiforme (see also breast, colorectal, lung, ovarian, other)

    Phase III(800) 626-3553

    Azedra™metaiodobenzylguanidine I-131(orphan Drug)

    Molecular Insights PharmaceuticalsCambridge, MA

    neuroblastoma (pediatric) (Fast Track), paraganglioma, pheochromocytoma (Fast Track)

    Phase II(617) 492-5554

    bafetinib CytRx Los Angeles, CA

    second-line brain cancer (see also leukemia, prostate)

    Phase I(310) 826-5648

    BKM120(PI3K inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    glioblastoma(see also breast, lung, other)

    Phase I/II(888) 669-6682

    ch14.18 mAb(orphan Drug)

    United TherapeuticsSilver Spring, MD

    neuroblastoma (children) Phase III(301) 608-9292

    cilengitide(orphan Drug)

    EMD SeronoRockland, MA

    newly-diagnosed glioblastoma(combination therapy)(see also prostate)

    Phase III(800) 283-8088

    cintredekin besudotox(orphan Drug)

    INSYS TherapeuticsPhoenix, AZ

    glioma (adolescents and children)(Fast Track)

    Phase I(602) 910-2617

    Cotara®monoclonal antibody TNT-1 (orphan Drug)

    Peregrine PharmaceuticalsTustin, CA

    recurrent glioblastoma(Fast Track)

    Phase II(714) 508-6000

    CPP-1X(eflornithine)

    Cancer Prevention PharmaceuticalsTucson, AZ

    neuroblastoma Phase I(520) 908-7774

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 5

    Brain CanCer

    product Name Sponsor Indication Development Status

    crenolanib (CP-868-596)

    AROG PharmaceuticalsDallas, TX

    glioma (adults)(see also stomach)--------------------------------------------------glioma (pediatric)

    Phase II(214) 594-0002-------------------------------------------Phase I(214) 594-0002

    DCVax®-Brainbrain cancer vaccine(orphan Drug)

    Northwest BiotherapeuticsBethesda, MD

    glioblastoma Phase II(240) 497-9024

    E7050 EisaiWoodcliff Lake, NJ

    second-line glioblastoma (see also head/neck, liver, skin, solid tumors, stomach)

    Phase I/II(888) 422-4743

    E7080(lenvatinib)

    EisaiWoodcliff Lake, NJ

    glioma(see also skin, other)

    Phase II(888) 422-4743

    EPO-806(patupilone)

    Novartis PharmaceuticalsEast Hanover, NJ

    brain metastases from lung cancer(see also prostate)

    Phase II(888) 669-6682

    G-100 prophage cancer vaccine(vitespen)(orphan Drug)

    AgenusLexington, MA

    newly-diagnosed glioma Phase II(781) 674-4400

    G-200 prophage cancer vaccine(vitespen)(orphan Drug)

    AgenusLexington, MA

    recurrent glioma Phase II(781) 674-4400

    GliAtak™gene therapy(orphan Drug)

    AdvantageneAuburndale, MA

    glioma

    --------------------------------------------------brain cancer (children)

    Phase II(617) 916-5445-------------------------------------------Phase I(617) 916-5445

    GMB-Vaxdendritic cell cancer vaccine

    Activartis BiotechVienna, Austria

    first-line glioblastoma Phase IIwww.activartis.com

    GRN1005(LRP directed peptide-drugconjugate)

    GeronMenlo Park, CA

    brain metastases

    --------------------------------------------------glioma

    Phase II(650) 473-7700-------------------------------------------Phase I completed(650) 473-7700

    GSK2118436(BRaf protein kinase inhibitor)

    GlaxoSmithKlineRsch. Triangle Park, NC

    brain metastases from melanoma(see also lung, skin)

    Phase II(888) 825-5249

    Hycamtin®topotecan

    GlaxoSmithKlineRsch. Triangle Park, NC

    metastatic brain cancer Phase III(888) 825-5249

    Medicines in Development for Cancer

  • Medicines in Development Cancer 20126

    Medicines in Development for Cancer

    Brain CanCer

    product Name Sponsor Indication Development Status

    ICT-107(dendritic cell vaccine)(orphan Drug)

    ImmunoCellular TherapeuticsWoodland Hills, CA

    glioblastoma Phase II(818) 992-2907

    Levulan® pDtaminolevulinic acid

    DUSA PharmaceuticalsWilmington, MA

    Phase II(978) 657-7500

    lonafarnib MerckWhitehouse Station, NJ

    glioblastoma Phase I(800) 672-6372

    Lucanix®belagenpumatucel-L

    NovaRxSan Diego, CA

    glioma(see also lung)

    Phase I(858) 522-8600

    macitentan Actelion Pharmaceuticals USSouth San Francisco, CA

    glioblastoma (combination therapy) Phase I(650) 624-6900

    MEDI-575(anti-PDGFR-alpha mAb)

    AstraZenecaWilmington, DEMedImmuneGaithersburg, MD

    glioblastoma(see also lung)

    Phase II(800) 236-9933(301) 398-0000

    mibefradil(T-type calcium channel inhibitor)(orphan Drug)

    Tau TherapeuticsCharlottesville, VA

    glioblastoma Phase I(434) 974-6969

    motexafin gadolinium PharmacyclicsSunnyvale, CA

    glioblastoma (combination therapy) Phase II(408) 774-0330

    nimotuzumab(orphan Drug)

    YM Biosciences USALehigh Valley, PA

    metastatic brain cancer, recurrent glioma (pediatric)(see also breast, prostate)

    Phase II(610) 560-0600

    olaratumab(LY3012207)

    Eli LillyIndianapolis, INImClone SystemsBridgewater, NJ

    glioblastoma(see also ovarian)

    Phase II(800) 545-5979

    opaxio™paclitaxel poliglumex

    Cell TherapeuticsSeattle, WA

    glioma, glioblastoma(see also lung, ovarian, stomach, other)

    Phase II(800) 215-2355

    perifosine AEterna ZentarisBasking Ridge, NJ

    refractory metastatic glioma(see also colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

    Phase II(908) 626-5428

  • Medicines in Development Cancer 2012 7

    Medicines in Development for Cancer

    Brain CanCer

    product Name Sponsor Indication Development Status

    PLX3397(CSF-1R kinase inhibitor)

    PlexxikonBerkeley, CA

    recurrent glioblastoma(see also leukemia, lymphoma, solid tumors)

    Phase II(510) 647-4000

    Poly-ICLC(orphan Drug)

    OncovirWashington, DC

    anaplastic astrocytoma (adolescents and children), glioblastoma (adolescents and children)

    Phase IIwww.oncovir.com

    PX-866 OncothyreonSeattle, WA

    second-line glioblastoma (see also head/neck, lung, prostate)

    Phase II(206) 801-2100

    Reolysin®reovirus

    Oncolytics BiotechCalgary, Canada

    glioma(see also colorectal, head/neck, lung, ovarian, pancreatic, sarcoma,skin, solid tumors)

    Phase I/II(403) 670-7377

    rindopepimut(orphan Drug)

    Celldex TherapeuticsNeedham, MA

    first-line glioblastoma (Fast Track)--------------------------------------------------second-line glioblastoma (Fast Track)

    Phase III(781) 433-0771-------------------------------------------Phase II(781) 433-0771

    SB-313-xTZ Sangamo BiosciencesRichmond, CA

    glioblastoma Phase I(510) 970-6000

    SBG Biotec PharmaconTromsø, Norway

    neuroblastoma (pediatric) Phase I/II completedwww.biotec.no

    SL-701(brain cancer vaccine)

    Stemline TherapeuticsNew York, NY

    glioma (adults)

    --------------------------------------------------glioma (children)

    Phase I/II(212) 831-1111-------------------------------------------Phase I/II(212) 831-1111

    SpRYCeL®dasatinib

    Bristol-Myers SquibbPrinceton, NJ

    glioblastoma(see also breast, pancreatic, prostate, other)

    in clinical trials(800) 332-2056

    tarceva®erlotinib(orphan Drug)

    GenentechSouth San Francisco, CAOSI PharmaceuticalsFarmingdale, NY

    late-stage brain metastases, recurrent ependymoma (children), glioblastoma(see also breast, head/neck, leukemia, liver, lung, other)

    Phase II(800) 626-3553(631) 962-0600

    terameprocol Erimos PharmaceuticalsHouston, TX

    glioma (intravenous)(see also cervical, head/neck, solid tumors, other)

    Phase I/II(713) 541-2000

    TGF-ß R1 inhibitor(LY2157299)

    Eli LillyIndianapolis, IN

    (see also liver) Phase II(800) 545-5979

  • Medicines in Development Cancer 20128

    Brain CanCer

    product Name Sponsor Indication Development Status

    TH-302 Threshold PharmaceuticalsSouth San Francisco, CA

    astrocytoma(see also leukemia, multiple myeloma, pancreatic, sarcoma)

    Phase II(650) 474-8200

    Toca 511/Toca FC(cytosine deaminase gene therapy)

    TocagenSan Diego, CA

    glioblastoma Phase I/II(858) 412-8400

    trans-sodium crocetinate (TSC)(orphan Drug)

    Diffusion PharmaceuticalsCharlottesville, VA

    gliobastoma Phase I/II(434) 220-0718

    TVI-Brain-1(cellular immunotherapyvaccine)

    TVAX BiomedicalLenexa, KS

    glioma Phase II(913) 492-2221

    VAL-083 Del Mar PharmaceuticalsVancouver, Canada

    grade IV malignant glioma Phase I/II(604) 629-5989

    VB-111 VBL TherapeuticsOr Yehuda, Israel

    glioblastoma(see also other)

    Phase I/IIwww.vblrx.com

    Xeloda®capecitabine

    GenentechSouth San Francisco, CA

    newly-diagnosed glioma (adolescents and children)(see also colorectal, liver, stomach)

    Phase I(800) 626-3553

    Zelboraf®vemurafenib

    GenentechSouth San Francisco, CAPlexxikonBerkeley, CA

    brain metastases(see also colorectal, other)

    Phase II(800) 626-3553

    Breast CanCer

    product Name Sponsor Indication Development Status

    18F-fluorothymidine MerckWhitehouse Station, NJ

    breast cancer (diagnosis) Phase II(800) 672-6372

    Abraxane®albumin-bound paclitaxel

    CelgeneSummit, NJ

    first-line metastatic breast cancer(see also bladder, lung, ovarian,pancreatic, skin)

    Phase II(908) 673-9000

    ABT-888 (veliparib)(PARP inhibitor)

    Abbott LaboratoriesAbbott Park, IL

    (see also brain, colorectal, lung, lymphoma, ovarian, prostate, skin, other)

    Phase II(847) 937-6100

    AC480(pan-HER inhibitor)

    Ambit BiosciencesSan Diego, CA

    (see also brain, lung) Phase I(858) 334-2100

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 9

    Breast CanCer

    product Name Sponsor Indication Development Status

    acolbifene(4th-generation SERM)

    EndoCeuticsQuebec, Canada

    Phase II(418) 653-0033

    AE37 peptide vaccine Antigen ExpressWorcester, MA

    (see also ovarian) Phase II(508) 852-8783

    afatinib(BIBW2992)

    Boehringer IngelheimPharmaceuticalsRidgefield, CT

    second-line metastatic breast cancer(see also brain, head/neck, lung)--------------------------------------------------first-line breast cancer

    Phase III(800) 243-0127-------------------------------------------Phase II(800) 243-0127

    afimoxifene ASCEND TherapeuticsHerndon, VA

    breast cancer (prevention) Phase II(703) 471-4744

    Afinitor®everolimus

    Novartis PharmaceuticalsEast Hanover, NJ

    HER2-positive breast cancer(see also kidney, lymphoma)

    Phase III(888) 669-6682

    AFP464 KiraxBonita Springs, FL

    Phase II(239) 444-5400

    amrubicin CelgeneSummit, NJ

    late-stage breast cancer (see also lung)

    Phase I/II(908) 673-9000

    ARC-100 Archer BiosciencesNew York, NY

    (see also brain, prostate, skin) Phase II(646) 747-9090

    ARRY-380(HER2 inhibitor)

    Array BioPharmaBoulder, CO

    Phase I(877) 633-2436

    AUY922(Hsp90 inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    breast cancer (monotherapy)(see also colorectal, lung, multiple myeloma, stomach)--------------------------------------------------breast cancer (combination therapy)

    Phase II(888) 669-6682

    -------------------------------------------Phase I/II(888) 669-6682

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201210

    Breast CanCer

    product Name Sponsor Indication Development Status

    Avastin®bevacizumab

    GenentechSouth San Francisco, CA

    adjuvant HER2-negative breast can-cer, adjuvant HER2-positive breast cancer, adjuvant triple negative breast cancer(see also brain, colorectal, lung, ovarian, other)

    Phase III(800) 626-3553

    AZD8931(erbB kinase inhibitor)

    AstraZenecaWilmington, DE

    advanced breast cancer (combination therapy)(see also solid tumors)

    Phase II(800) 236-9933

    BAY 86-5044 (lonaprisan)

    Bayer HealthCare PharmaceuticalsWayne, NJ

    metastatic breast cancer Phase II completed(888) 842-2937

    BIIB 2024 Biogen IdecCambridge, MA

    (see also stomach) Phase II completed(617) 679-2000

    BKM120(PI3K inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    second-line breast cancer(see also brain, lung, other)

    Phase I/II(888) 669-6682

    breast cancer vaccine (dendritic cell vaccine)

    Quantum ImmunologicsTampa, FL

    Phase I/II(866) 213-4594

    brostallicin Cell TherapeuticsSeattle, WA

    triple-negative breast cancer Phase I(800) 215-2355

    BTSCAN Molecular Targeting TechnologiesWest Chester, PA

    breast cancer (diagnosis) Phase I(610) 738-7938

    BZL-101 BionovoEmeryville, CA

    Phase I(510) 601-2000

    cabozantinib(XL184)

    ExelixisSouth San Francisco, CA

    (see also kidney, lung, ovarian, prostate, other)

    Phase II(650) 837-7000

    cancer vaccine MabVax TherapeuticsSan Diego, CA

    (see also sarcoma) Phase I(858) 259-9405

    CDX-011(glembatumumab vedotin)

    Celldex TherapeuticsNeedham, MA

    breast cancer (Fast Track)(see also skin)

    Phase II(781) 433-0771

    CV-301(cancer vaccine)

    BN ImmunoTherapeuticsMountain View, CA

    metastatic breast cancer Phase II(650) 681-4660

    D-1MT NewLink GeneticsAmes, IA

    second-line metastatic breast cancer(see also solid tumors)

    Phase I/II(515) 296-5555

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 11

    Breast CanCer

    product Name Sponsor Indication Development Status

    dalotuzumab(MK-0646)

    MerckWhitehouse Station, NJ

    second-line breast cancer (combination therapy)(see also lung, pancreatic, other)--------------------------------------------------first-line breast cancer

    Phase II(800) 672-6372

    -------------------------------------------Phase I(800) 672-6372

    DPX-0907 ImmunovaccineHalifax, Canada

    (see also ovarian, prostate) Phase I(902) 492-1819

    eniluracil Adherex TechnologiesRsch. Triangle Park, NC

    metastatic breast cancer(combination therapy)

    Phase II(919) 636-4530

    entinostat Syndax PharmaceuticalsWaltham, MA

    (see also colorectal, kidney, leukemia, lung, lymphoma)

    Phase II(781) 419-1400

    etirinotecan pegol (NKTR-102)

    Nektar TherapeuticsSan Francisco, CA

    metastatic breast cancer(see also colorectal, ovarian, solid tumors)

    Phase III(855) 482-6587

    EZN-2208(PEG-SN38, firtecan pegol)

    Enzon PharmaceuticalsPiscataway, NJ

    metastatic breast cancer(see also colorectal, solid tumors)

    Phase II(973) 980-4500

    Faslodex®fulvestrant

    AstraZenecaWilmington, DE

    first-line advanced breast cancer Phase III(800) 236-9933

    folate binding protein (E39) vaccine

    Galena BiopharmaLake Oswego, OR

    (see also ovarian, other) Phase I(855) 855-4253

    Folotyn®pralatrexate

    Allos TherapeuticsWestminster, CO

    (see also bladder, lung, lymphoma) Phase II(303) 426-6262

    ganetespib (Hsp90i)

    Synta PharmaceuticalsLexington, MA

    (see also colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach)

    Phase II(781) 274-8200

    ganitumab(AMG 479)

    AmgenThousand Oaks, CA

    combination therapy(see also colorectal, lung, pancreatic, sarcoma)

    Phase II(800) 772-6436

    GDC-0980(PI3 kinase/mTOR dual inhibitor)

    GenentechSouth San Francisco, CA

    hormone receptor-positive breast cancer(see also lymphoma, solid tumors)

    Phase II(800) 626-3553

    GSK2302024A(WT1 antigen-specific cancerimmunotherapeutic)

    GlaxoSmithKlineRsch. Triangle Park, NC

    neoadjuvant breast cancer Phase I/II(888) 825-5249

    GVAX® Breastcancer vaccine

    BioSante PharmaceuticalsLincolnshire, IL

    Phase I(847) 478-0500

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201212

    Breast CanCer

    product Name Sponsor Indication Development Status

    HER2 antigen-specific cancerimmunotherapeutic

    GlaxoSmithKlineRsch. Triangle Park, NC

    Phase II(888) 825-5249

    icrucumab(LY3012212/IMC-18F1)

    Eli LillyIndianapolis, INImCloneBridgewater, NJ

    metastatic breast cancer(see also bladder, colorectal)

    Phase II(800) 545-5979

    imetelstat GeronMenlo Park, CA

    metastatic breast cancer(combination therapy)(see also leukemia, lung, multiple myeloma)

    Phase II(650) 473-7700

    IMT-1012 immunotherapeuticvaccine

    ImmunotopeDoylestown, PA

    (see also ovarian) Phase I(215) 253-4180

    indibulin(ZIO-301)

    ZIOPHARM OncologyNew York, NY

    late-stage breast cancer Phase I/II(646) 214-0700

    iniparib(BSI-201)

    Sanofi USBridgewater, NJ

    neoadjuvant breast cancer(see also lung, ovarian)

    Phase II(800) 981-2491

    KW-2450 Kyowa Hakko Kirin PharmaPrinceton, NJ

    first-line breast cancer, second-line breast cancer

    Phase I/II(609) 919-1100

    LFA102(anti-prolactin receptor anti-body)

    Novartis PharmaceuticalsEast Hanover, NJXOMABerkeley, CA

    (see also prostate) Phase I(888) 669-6682

    LGK974(WNT signaling pathway inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    (see also skin) Phase I(888) 669-6682

    linifanib Abbott LaboratoriesAbbott Park, IL

    breast cancer (combination therapy)(see also colorectal, kidney, liver, lung)

    Phase II(847) 937-6100

    liposome encapsulated paclitaxel (LEP-ETU)

    Insys TherapeuticsPhoenix, AZ

    Phase II(602) 910-2617

    litronesib(LY2523355)

    Eli LillyIndianapolis, IN

    metastatic breast cancer(see also lung)

    Phase II(800) 545-5979

    LOR-2040 Lorus TherapeuticsToronto, Canada

    metastatic breast cancer(see also colorectal, kidney, leukemia, prostate)

    Phase II(416) 798-1200

    Lymphoseek®Tc-99m tilmanocept

    Navidea PharmaceuticalsDublin, OH

    breast cancer (diagnosis)(see also head/neck, skin)

    application submitted(614) 793-7500

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 13

    Breast CanCer

    product Name Sponsor Indication Development Status

    maraciclatide GE HealthcareWaukesha, WI

    breast cancer (diagnosis) in clinical trialswww.gehealthcare.com

    MK-0752(notch signaling pathway inhibitor)

    MerckWhitehouse Station, NJ

    early-stage breast cancer, late-stage breast cancer(see also other)

    Phase I(800) 672-6372

    MK-2206(c-akt inhibitor)

    MerckWhitehouse Station, NJ

    HER2-positive breast cancer(see also other)

    Phase I(800) 672-6372

    MM-111 Merrimack PharmaceuticalsCambridge, MA

    breast cancer (combination therapy) Phase I/II(617) 441-1000

    MM-302(anti-HER2 antibody doxorubicin conjugate)

    Merrimack PharmaceuticalsCambridge, MA

    Phase I(617) 441-1000

    motesanib AmgenThousand Oaks, CA

    (see also colorectal, lung, other) Phase I/II(800) 772-6436

    MVA-BN® HeR2(HER-2/neu-based MVA vaccine)

    BN ImmunoTherapeuticsMountain View, CA

    Phase I(650) 681-4660

    Myocet™doxorubicin liposomal

    Sopherion TherapeuticsPrinceton, NJ

    first-line breast cancer (combination therapy) (Fast Track)

    Phase III(609) 986-2020

    NeuVax™cancer vaccine E75

    Galena BiopharmaLake Oswego, OR

    early-stage breast cancer(prevention of relapse)(see also prostate)

    Phase III(855) 855-4253

    Nexavar®sorafenib

    Bayer HealthCare PharmaceuticalsWayne, NJ

    (see also colorectal, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other)

    Phase III(888) 842-2937

    nimotuzumab YM Biosciences USALehigh Valley, PA

    (see also brain, prostate) Phase I(610) 560-0600

    NK-012 Nippon KayakuTokyo, Japan

    (see also lung) Phase IIwww.nipponkayaku.co.jp

    OBP-301 Oncolys BiopharmaTokyo, Japan

    (see also head/neck, liver, lung) Phase Iwww.oncolys.com

    OGX-427 OncoGenex PharmaceuticalsBothell, WA

    (see also lung, ovarian) Phase I(425) 686-1500

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201214

    Breast CanCer

    product Name Sponsor Indication Development Status

    onartuzumab GenentechSouth San Francisco, CA

    metastatic breast cancer (combination therapy)(see also colorectal, lung)

    Phase II(800) 626-3553

    OPT-822/OPT-821 Optimer BiotechnologySan Diego, CA

    Phase II/III(858) 909-0736

    PB-272 (neratinib) Puma BiotechnologyLos Angeles, CA

    second-line breast cancer, neoadjuvant breast cancer

    Phase II(424) 248-6500

    pertuzumab GenentechSouth San Francisco, CA

    first-line metastatic breast cancer

    --------------------------------------------------second-line late-stage breast cancer

    application submitted(800) 626-3553-------------------------------------------Phase II(800) 626-3553

    pertuzumab companion diagnostic(HER2 FISH pharmDx™)

    DakoGlostrup, DenmarkGenentechSouth San Francisco, CA

    breast cancer (diagnostic) Phase IIIwww.dako.com(800) 626-3553

    pertuzumab companiondiagnostic(HercepTest™)

    DakoGlostrup, DenmarkGenentechSouth San Francisco, CA

    breast cancer (diagnosis) Phase IIIwww.dako.com(800) 626-3553

    pixantrone Cell TherapeuticsSeattle, WA

    breast cancer (Fast Track)(see also lymphoma)

    Phase II(800) 215-2355

    PTC299 PTC TherapeuticsSouth Plainfield, NJ

    (see also solid tumors, other) Phase I/II(908) 222-7000

    Quinamed®amonafide

    CephalonFrazer, PA

    (see also ovarian, prostate) Phase II(610) 344-0200

    ramucirumab(IMC-1121B)

    Eli LillyIndianapolis, INImClone SystemsBridgewater, NJ

    metastatic breast cancer(see also colorectal, stomach)

    Phase III(800) 545-5979

    Reximmune-C®personalized cancer vaccine

    Epeius BiotechnologiesSan Marino, CA

    Phase I/II(626) 441-6695

    Rexin-G® Epeius BiotechnologiesSan Marino, CA

    metastatic breast cancer(see also pancreatic, sarcoma)

    Phase I/II(626) 441-6695

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 15

    Breast CanCer

    product Name Sponsor Indication Development Status

    ridaforolimus ARIAD PharmaceuticalsCambridge, MAMerckWhitehouse Station, NJ

    metastatic breast cancer(see also kidney, lung, prostate, sarcoma, other)

    Phase II(800) 672-6372

    rucaparib Clovis OncologyBoulder, CO

    (see also ovarian) Phase II(303) 625-5000

    sagopilone Bayer HealthCare PharmaceuticalsWayne, NJ

    (see also ovarian, prostate) Phase II completed(888) 842-2937

    samarium SM-153 lexidronaminjection

    EUSA PharmaLanghorne, PA

    (see also multiple myeloma, prostate, sarcoma, other)

    Phase II(800) 833-3533

    SAR245408 (XL147)(oral PI3K inhibitor)

    Sanofi USBridgewater, NJExelixis South San Francisco, CA

    (see also other) Phase II(800) 981-2491(650) 837-7000

    SAR245409 (XL765)(PI3K/mTOR inhibitor)

    Sanofi USBridgewater, NJExelixis South San Francisco, CA

    (see also lymphoma) Phase II(800) 981-2491(650) 837-7000

    SAR256212 (MM-121)(anti-ErbB3 mAb)

    Merrimack PharmaceuticalsCambridge, MASanofi USBridgewater, NJ

    (see also lung, ovarian) Phase II(800) 981-2491

    SF1 (sonodynamic therapy) SonneMedBoston, MA

    advanced breast cancer Phase I/IIwww.sonnemed.com

    SpRYCeL®dasatinib

    Bristol-Myers SquibbPrinceton, NJ

    (see also brain, pancreatic, prostate, other)

    in clinical trials(800) 332-2056

    SR 16234 SRI InternationalMenlo Park, CA

    Phase II(650) 859-2000

    tarceva®erlotinib

    GenentechSouth San Francisco, CAOSI PharmaceuticalsFarmingdale, NY

    (see also brain, head/neck, leukemia, liver, lung, other)

    Phase II(800) 626-3553(631) 962-0600

    tesetaxel GentaBerkeley Heights, NJ

    first-line breast cancer (see also bladder, prostate, skin, stomach)

    Phase II(908) 286-9800

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201216

    Breast CanCer

    product Name Sponsor Indication Development Status

    thermoDox®doxorubicin liposomal

    CelsionLawrenceville, NJ

    recurrent breast cancer(see also colorectal, liver)

    Phase I/II(609) 896-9100

    tigatuzumab(anti-DR5 antibody)

    Daiichi SankyoParsippany, NJ

    (see also colorectal, liver, lymphoma, ovarian, pancreatic)

    Phase II(973) 944-2600

    tivozanib(ASP4130/AV-951)

    Astellas Pharma USDeerfield, ILAVEO PharmaceuticalsCambridge, MA

    breast cancer (combination therapy)(see also colorectal, kidney)

    Phase I/II(800) 695-4321(617) 299-5000

    TKI258(dovitinib)

    Novartis PharmaceuticalsEast Hanover, NJ

    metastatic breast cancer(see also kidney, multiple myeloma, prostate, skin, other)

    Phase II(888) 669-6682

    trabectedin Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

    metastatic breast cancer (see also ovarian, prostate, sarcoma)

    Phase III(800) 817-5286

    trastuzumab-DM1(RG3502)

    GenentechSouth San Francisco, CA

    Phase III(800) 626-3553

    trastuzumab-DM1 companion diagnostic(HercepTest™)

    DakoGlostrup, DenmarkGenentechSouth San Francisco, CA

    breast cancer (diagnosis) Phase IIIwww.dako.com(800) 626-3553

    trastuzumab-DM1 companion diagnostic(HER2 FISH pharmDx™)

    DakoGlostrup, DenmarkGenentechSouth San Francisco, CA

    breast cancer (diagnosis) Phase IIIwww.dako.com(800) 626-3553

    TRC 105(ENG protein inhibitor)

    TRACON PharmaceuticalsSan Diego, CA

    (see also ovarian, prostate, other) Phase I/II(858) 550-0780

    trebananib (AMG386)

    AmgenThousand Oaks, CA

    (see also colorectal, kidney, liver, ovarian, stomach, other)

    Phase II(800) 772-6436

    tykerb®lapatinib

    GlaxoSmithKlineRsch. Triangle Park, NC

    inflammatory breast cancer (see also colorectal, head/neck, stomach)--------------------------------------------------adjuvant breast cancer, first-line metastatic breast cancer--------------------------------------------------neoadjuvant breast cancer

    application submitted(888) 825-5249

    -------------------------------------------Phase III(888) 825-5249-------------------------------------------Phase II(888) 825-5249

    upamostat (WX-671)

    WilexMunich, Germany

    Phase IIwww.wilex.de

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 17

    Breast CanCer

    product Name Sponsor Indication Development Status

    varlitinib ASLAN PharmaceuticalsSingapore

    Phase IIwww.aslanpharma.com

    VeriStrat®companion diagnostic testEGFR-TKI

    BiodesixBoulder, CO

    advanced breast cancer (diagnosis-outcome test in HER2-overexpressing tumors)

    Phase III(303) 417-0500

    YM155(sepantronium)

    Astellas Pharma USDeerfield, IL

    (see also lymphoma) Phase II(800) 695-4321

    Zolinza®vorinostat

    MerckWhitehouse Station, NJ

    (see also leukemia, lung, lymphoma, multiple myeloma, other)

    Phase II(800) 672-6273

    Zytiga®abiraterone

    Janssen BiotechHorsham, PA

    second-line metastatic breast cancer(see also prostate)

    Phase II(800) 526-7736

    CerviCal CanCer

    product Name Sponsor Indication Development Status

    ADXS-HPV AdvaxisPrinceton, NJ

    cervical cancer, cervical intraepithelial neoplasia

    Phase II(609) 452-9813

    PM-00104 PharmaMarMadrid, Spain

    (see also sarcoma, other) Phase IIwww.pharmamar.com

    PV701(replication-competent oncolytic virus)

    Wellstat BiologicsGaithersburg, MD

    (see also colorectal) Phase II(240) 683-2500

    terameprocol Erimos PharmaceuticalsHouston, TX

    cervical intraepithelial neoplasia (intravaginal)(see also brain, head/neck, solid tumors, other)

    Phase II(713) 541-2000

    V503(HPV virus-like particle (VLP) vaccine)

    MerckWhitehouse Station, NJ

    prevention of cervical cancer, prevention of vulvovaginal cancer

    Phase III(800) 672-6372

    V505(HPV vaccine)

    MerckWhitehouse Station, NJ

    prevention of cervical cancer Phase II completed(800) 672-6372

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201218

    CerviCal CanCer

    product Name Sponsor Indication Development Status

    verpasep caltespen(cancer vaccine)

    Akela PharmaAustin, TX

    cervical intraepithelial neoplasia Phase I completed(512) 834-0449

    VGX-3100(DNA cancer vaccine)

    Inovio PharmaceuticalsBlue Bell, PA

    cervical intraepithelial neoplasia Phase II(877) 446-6846

    ColoreCtal CanCer

    product Name Sponsor Indication Development Status

    ABT-888 (veliparib)(PARP inhibitor)

    Abbott LaboratoriesAbbott Park, IL

    (see also brain, breast, lung, lymphoma, ovarian, prostate, skin, other)

    Phase II(847) 937-6100

    Aptocine™talaporfin

    Light Sciences OncologyBellevue, WA

    metastatic colorectal cancer Phase III(425) 957-8900

    AUY922(Hsp90 inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    second-line colorectal cancer (combination therapy)(see also breast, lung, multiplemyeloma, stomach)

    Phase I(888) 669-6682

    Avastin®bevacizumab

    GenentechSouth San Francisco, CA

    metastatic colorectal cancer (treatment beyond progression) (see also brain, breast, lung, ovarian, other)

    Phase III(800) 626-3553

    AVX701(CEA cancer immunotherapy)

    AlphaVaxRsch. Triangle Park, NC

    colorectal cancer prevention in patients with advanced or metastatic CEA-expressing malignancies

    Phase I/II(919) 595-0400

    belinostat Spectrum PharmaceuticalsHenderson, NV

    colorectal cancer (combination therapy)(see also leukemia, liver, lung, lymphoma, ovarian, other)

    Phase I/II(702) 835-6300

    brivanib(VEGFR/FGFR kinase inhibitor)

    Bristol-Myers SquibbPrinceton, NJ

    metastatic colorectal cancer(see also liver, sarcoma)

    Phase II(800) 332-2056

    CPX-1(irinotecan/floxuridine)

    Celator PharmaceuticalsPrinceton, NJ

    Phase II completed(609) 243-0123

    CT-011 CureTechYavne, Israel

    first-line metastatic colorectal cancer (combination therapy)(see also leukemia, lymphoma)

    Phase IIwww.curetechbio.com

    E7820 EisaiWoodcliff Lake, NJ

    Phase II(888) 422-4743

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 19

    ColoreCtal CanCer

    product Name Sponsor Indication Development Status

    efatutazone Daiichi SankyoParsippany, NJ

    metastatic colorectal cancer(see also lung, other)

    Phase II(973) 944-2600

    EGEN-001 EGENHuntsville, AL

    (see also ovarian, other) Phase I/II(256) 512-0077

    EGFR antagonist companion diagnostic

    QIAGENValencia, CA

    colorectal cancer (diagnosis) application submittedwww.qiagen.com

    encapsulated cell therapy(macrobeads)

    Rogosin InstituteNew York, NY

    refractory metastatic colorectal cancer(see also pancreatic, prostate)

    Phase II(212) 746-1566

    entinostat Syndax PharmaceuticalsWaltham, MA

    metastatic colorectal cancer(combination therapy)(see also breast, kidney, leukemia, lung, lymphoma)

    Phase II(781) 419-1400

    eRBItUX®cetuximab

    Bristol-Myers SquibbPrinceton, NJEli LillyIndianapolis, IN

    first-line colorectal cancer(see also stomach)

    in clinical trials(800) 332-2056(800) 545-5979

    etirinotecan pegol(NKTR-102)

    Nektar TherapeuticsSan Francisco, CA

    second-line colorectal cancer(see also breast, ovarian, solid tumors)

    Phase II/III(855) 482-6587

    EZN-2208(PEG-SN38, firtecan pegol)

    Enzon PharmaceuticalsPiscataway, NJ

    metastatic colorectal cancer(see also breast, solid tumors)

    Phase II(973) 980-4500

    FANG™ Vaccineautologous tumor cell vaccine

    GradalisCarrollton, TX

    (see also ovarian, skin) Phase II(214) 442-8100

    ganetespib (Hsp90i)

    Synta PharmaceuticalsLexington, MA

    refractory, metastatic colorectal cancer(see also breast, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach)

    Phase II(781) 274-8200

    ganitumab(AMG 479)

    AmgenThousand Oaks, CA

    second-line metastatic colorectal cancer (combination therapy)(see also breast, lung, pancreatic, sarcoma)

    Phase II(800) 772-6436

    GI-4000(cancer vaccine)

    GlobeImmuneLouisville, CO

    (see also lung, pancreatic) Phase II(303) 625-2700

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201220

    ColoreCtal CanCer

    product Name Sponsor Indication Development Status

    GM-CT-01 Galectin TherapeuticsNewton, MA

    colorectal cancer (combination therapy)

    Phase II(617) 559-0033

    GS-6624(monoclonal antibody)

    Gilead SciencesFoster City, CA

    (see also pancreatic) Phase II(800) 445-3235

    GVAX® Colorectalcancer vaccine

    BioSante PharmaceuticalsLincolnshire, IL

    Phase I(847) 478-0500

    icrucumab(LY3012212/IMC-18F1)

    Eli LillyIndianapolis, INImCloneBridgewater, NJ

    (see also bladder, breast) Phase II(800) 545-5979

    IMO-2055(TLR9 agonist)

    Idera PharmaceuticalsCambridge, MA

    (see also head/neck, lung) Phase I(617) 679-5000

    Imprime pGG® BiotheraEagan, MN

    (see also leukemia, lung, skin) Phase III(651) 675-0300

    JX-594 (pexastimogene devacirepvec)

    Jennerex BiotherapeuticsSan Francisco, CA

    (see also liver) Phase I/II(415) 281-8886

    KRN-330 Kyowa Hakko Kirin PharmaPrinceton, NJ

    colorectal cancer (combination therapy)--------------------------------------------------colorectal cancer (monotherapy)

    Phase I/II(609) 919-1100-------------------------------------------Phase I(609) 919-1100

    labetuzumab I-131(IMMU-111)

    ImmunomedicsMorris Plains, NJ

    Phase II(973) 605-8200

    labetuzumab-SN-38(IMMU-130)

    ImmunomedicsMorris Plains, NJ

    Phase I(973) 605-8200

    LGX818(RAF inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    metastatic colorectal cancer(see also skin)

    Phase I(888) 669-6682

    linifanib Abbott LaboratoriesAbbott Park, IL

    second-line colorectal cancer(see also breast, kidney, liver, lung)

    Phase II(847) 937-6100

    LOR-2040 Lorus TherapeuticsToronto, Canada

    metastatic colorectal cancer(see also breast, kidney, leukemia, prostate)

    Phase II(416) 798-1200

    motesanib AmgenThousand Oaks, CA

    (see also breast, lung, other) Phase I(800) 772-6436

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 21

    ColoreCtal CanCer

    product Name Sponsor Indication Development Status

    Nexavar®sorafenib

    Bayer HealthCare PharmaceuticalsWayne, NJ

    metastatic colorectal cancer (see also breast, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other)

    Phase II(888) 842-2937

    NPC-1C(ensituximab)

    Neogenix OncologyRockville, MD

    metastatic colorectal cancer(see also pancreatic)

    Phase I(301) 917-6893

    onartuzumab GenentechSouth San Francisco, CA

    (see also breast, lung) Phase II(800) 626-3553

    oncoVAX®active specific immunotherapy

    VaccinogenFrederick, MD

    (Fast Track) Phase I/II(301) 668-8400

    perifosine AEterna ZentarisBasking Ridge, NJ

    refractory metastatic colorectal cancer (combination therapy)(Fast Track)(see also brain, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

    Phase III(908) 626-5428

    PHY906 PhytoCeuticaNew Haven, CT

    (see also liver, pancreatic, cancer-related)

    Phase I/II(203) 777-3462

    picoplatin Ponaird PharmaceuticalsSeattle, WA

    (see also lung, ovarian, prostate) Phase II(206) 281-7001

    polyclonal antibody stimulator Cancer AdvancesDurham, NC

    (see also pancreatic, stomach) Phase II(919) 361-2162

    PV701(replication-competent oncolytic virus)

    Wellstat BiologicsGaithersburg, MD

    (see also cervical) Phase II(240) 683-2500

    ramucirumab(IMC-1121B)

    Eli LillyIndianapolis, INImCloneBridgewater, NJ

    (see also breast, stomach) Phase III(800) 545-5979

    regorafenib Bayer HealthCare PharmaceuticalsWayne, NJ

    metastatic colorectal cancer (Fast Track)(see also kidney, lung, solid tumors, stomach)

    Phase III(888) 842-2837

    Reolysin®reovirus

    Oncolytics BiotechCalgary, Canada

    (see also brain, head/neck, lung, ovarian, pancreatic, sarcoma,skin, solid tumors)

    Phase I(403) 670-7377

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201222

    ColoreCtal CanCer

    product Name Sponsor Indication Development Status

    RG7160(EGFR inhibitor)

    RocheNutley, NJ

    second-line metastatic colorectal cancer (combination therapy)

    Phase II(973) 235-5000

    RG7414(EGFL7 inhibitor)

    GenentechSouth San Francisco, CA

    (see also lung) Phase II(800) 626-3553

    RIGScan™tumor-specific, radio-labeled monoclonal antibody targeting agent

    Navidea BiopharmaceuticalsDublin, OH

    metastatic colorectal cancer (diagnosis)

    application submitted(800) 793-0079

    robatumumab MerckWhitehouse Station, NJ

    (see also sarcoma, solid tumors) Phase II completed(800) 672-6372

    Sym004 SymphogenLyngby, Denmark

    metastatic colorectal cancer Phase IIwww.symphogen.com

    TAS-102 Taiho Pharma U.S.A.Princeton, NJ

    Phase I(609) 750-5300

    telatinib ACT BiotechSan Francisco, CA

    (see also stomach) Phase I(415) 230-3900

    TF2(pretargeted radioimmuno-therapy)

    ImmunomedicsMorris Plains, NJ

    colorectal cancer Phase I(973) 605-8200

    thermoDox®doxorubicin liposomal

    CelsionLawrenceville, NJ

    adjuvant inoperable/unresectable, metastatic colorectal cancer(see also breast, liver)

    Phase II(609) 896-9100

    tigatuzumab(anti-DR5 antibody)

    Daiichi SankyoParsippany, NJ

    (see also breast, liver, lymphoma, ovarian, pancreatic)

    Phase I(973) 944-2600

    tivantinib (ARQ 197)

    ArQuleWoburn, MADaiichi SankyoParsippany, NJ

    (see also kidney, liver, lung, pancreatic, sarcoma, other)

    Phase I/II(781) 994-0300(973) 944-2600

    tivozanib(ASP4130/AV-951)

    Astellas Pharma USDeerfield, ILAVEO PharmaceuticalsCambridge, MA

    colorectal cancer (combination therapy)(see also breast, kidney)

    Phase II(800) 695-4321(617) 299-5000

    trebananib (AMG386)

    AmgenThousand Oaks, CA

    (see also breast, kidney, liver, ovarian, stomach, other)

    Phase II(800) 772-6436

    tykerb®lapatinib

    GlaxoSmithKlineRsch. Triangle Park, NC

    metastatic colorectal cancer(see also breast, head/neck, stomach)

    Phase II(888) 825-5249

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 23

    ColoreCtal CanCer

    product Name Sponsor Indication Development Status

    Vectibix®panitumumab

    AmgenThousand Oaks, CA

    first-line and second-line colorectal cancer (see also head/neck)

    application submitted(800) 772-6436

    Xeloda®capecitabine

    GenentechSouth San Francisco, CA

    first-line and second-line metastatic colorectal cancer (combination therapy)(see also brain, liver, stomach)

    application submitted(800) 626-3553

    Zaltrap™aflibercept

    Regeneron PharmaceuticalsTarrytown, NYSanofi USBridgewater, NJ

    second-line metastatic colorectal cancer(see also prostate)

    application submitted(914) 345-7400(800) 981-2491

    Zelboraf®vemurafenib

    GenentechSouth San Francisco, CAPlexxikonBerkeley, CA

    (see also brain, other) Phase I(800) 626-3553

    Head/neCk CanCer

    product Name Sponsor Indication Development Status

    ACE-041(dalantercept)

    Acceleron PharmaCambridge, MA

    (see also multiple myeloma) Phase II(617) 649-9200

    afatinib(BIBW2992)

    Boehringer IngelheimPharmaceuticalsRidgefield, CT

    second-line head/neck cancer(see also breast, brain, lung)

    Phase II(800) 243-0127

    AP5346 Access PharmaceuticalsDallas, TX

    Phase II(214) 905-5100

    E7050 EisaiWoodcliff Lake, NJ

    (see also brain, liver, skin, solid tumors, stomach)

    Phase I/II(888) 422-4743

    foretinib(GSK1363089)

    GlaxoSmithKlineRsch. Triangle Park, NC

    (see also kidney, liver, lung) Phase II completed(888) 825-5249

    GL-0810(orphan Drug)

    GliknikBaltimore, MD

    Phase Iwww.gliknik.com

    GL-0817(orphan Drug)

    GliknikBaltimore, MD

    (see also multiple myeloma) Phase Iwww.gliknik.com

    HF-10 Takara BioShiga, Japan

    Phase Iwww.takara-bio.com

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201224

    Head/neCk CanCer

    product Name Sponsor Indication Development Status

    IMO-2055(TLR9 agonist)

    Idera PharmaceuticalsCambridge, MA

    second-line head and neck cancer(combination therapy)(see also colorectal, lung)

    Phase II(617) 679-5000

    IRX-2 IRX TherapeuticsNew York, NY

    (Fast Track) Phase II(212) 582-1199

    Lymphoseek®Tc-99m tilmanocept

    Navidea PharmaceuticalsDublin, OH

    head and neck cancer (diagnosis)(see also breast, skin)

    Phase III(614) 793-7500

    Multikine®leukocyte interleukin(orphan Drug)

    CEL-SCIVienna, VA

    first-line head and neck cancer Phase III(703) 506-9460

    Nexavar®sorafenib

    Bayer HealthCare PharmaceuticalsWayne, NJ

    (see also breast, colorectal, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other)

    Phase II(888) 842-2937

    OBP-301 Oncolys BiopharmaTokyo, Japan

    (see also breast, liver, lung) Phase Iwww.oncolys.com

    PX-866 OncothyreonSeattle, WA

    head and neck cancer (combination therapy)(see also brain, lung, prostate)

    Phase II(206) 801-2100

    Reolysin®reovirus

    Oncolytics BiotechCalgary, Canada

    metastatic head and neck cancer (combination therapy)(see also brain, colorectal, lung, ovarian, pancreatic, sarcoma, skin, solid tumors)

    Phase III(403) 670-7377

    RG7597(EGFR antagonist)

    GenentechSouth San Francisco, CA

    Phase II(800) 626-3553

    seliciclib(CYC202)

    Cyclacel PharmaceuticalsBerkeley Heights, NJ

    nasopharyngeal cancer (see also solid tumors)

    Phase II(908) 517-7330

    tarceva®erlotinib

    GenentechSouth San Francisco, CAOSI PharmaceuticalsFarmingdale, NY

    first-line head/neck cancer (combination therapy)(see also brain, breast, leukemia,liver, lung, other)

    Phase II(800) 626-3553(631) 962-0600

    TAS-106 Taiho Pharma U.S.A.Princeton, NJ

    Phase II(609) 750-5300

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 25

    Head/neCk CanCer

    product Name Sponsor Indication Development Status

    terameprocol Erimos PharmaceuticalsHouston, TX

    head and neck cancer (intratumoral)(see also brain, cervical, solid tumors, other)

    Phase I(713) 541-2000

    tNFerade™golnerminogene pradenovec

    GenVecGaithersburg, MD

    (see also prostate, skin, stomach) Phase I/II completed(877) 943-6832

    tykerb®lapatinib

    GlaxoSmithKlineRsch. Triangle Park, NC

    head and neck squamous cell carcinoma (resectable disease)(see also breast, colorectal, stomach)

    Phase III(888) 825-5249

    VB4-845(orphan Drug)

    Viventia BiotechnologiesMississauga, Canada

    (Fast Track)(see also bladder)

    Phase II(905) 362-2973

    Vectibix®panitumumab

    AmgenThousand Oaks, CA

    first-line head and neck cancer(see also colorectal)--------------------------------------------------second-line head and neck cancer

    Phase III(800) 772-6436-------------------------------------------Phase II(800) 772-6436

    kidney CanCer

    product Name Sponsor Indication Development Status

    Afinitor®everolimus

    Novartis PharmaceuticalsEast Hanover, NJ

    hepatocellular carcinoma(see also breast, lymphoma)

    Phase II(888) 669-6682

    AGS-003(personalized dendritic cell vaccine)

    Argos TherapeuticsDurham, NC

    renal cancer (combination therapy)(Fast Track)--------------------------------------------------metastatic renal cancer (monotherapy)

    Phase II(919) 287-6300-------------------------------------------Phase II(919) 287-6300

    AMG 172 AmgenThousand Oaks, CA

    Phase I(800) 772-6436

    anti-PD1 (BMS-936558)

    Bristol-Myers SquibbPrinceton, NJ

    renal cell carcinoma(see also lung, skin)

    Phase II(800) 332-2056

    BNC105 BionomicsThebarton, Australia

    Phase IIwww.bionomics.com.au

    cabozantinib(XL184)

    ExelixisSouth San Francisco, CA

    renal cell carcinoma(see also breast, lung, ovarian, prostate, other)

    Phase I(650) 837-7000

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201226

    kidney CanCer

    product Name Sponsor Indication Development Status

    CVX 060 (PF-04856884)(Ang2 antagonist)

    PfizerNew York, NY

    renal cell carcinoma(see also solid tumors)

    Phase II(860) 732-5156

    CYT107(interleukin-7)

    CytherisRockville, MD

    (see also skin) Phase I(301) 231-0451

    entinostat Syndax PharmaceuticalsWaltham, MA

    (see also breast, colorectal, leukemia, lung, lymphoma)

    Phase I/II(781) 419-1400

    foretinib(GSK1363089)

    GlaxoSmithKlineRsch. Triangle Park, NC

    (see also head/neck, liver, lung) Phase II(888) 825-5249

    IMA901(cancer vaccine)

    immatics biotechnologiesTüebingen, Germany

    renal cancer Phase IIIwww.immatics.com

    Inlyta®axitinib(orphan Drug)

    PfizerNew York, NY

    advanced renal cell carcinoma in treatment-naive patients(see also liver, other)

    Phase III(860) 732-5156

    Istodax®romidepsin

    CelgeneSummit, NJ

    renal cancer(see also pancreatic, prostate, other)

    Phase II(908) 673-9000

    LBH589 (panobinostat)

    Novartis PharmaceuticalsEast Hanover, NJ

    renal cancer(see also leukemia, multiple myeloma, prostate, solid tumors)

    Phase II(888) 669-6682

    linifanib Abbott LaboratoriesAbbott Park, IL

    renal cancer (see also breast, colorectal, liver, lung)

    Phase II(847) 937-6100

    LOR-2040(orphan Drug)

    Lorus TherapeuticsToronto, Canada

    metastatic renal cancer(see also breast, colorectal, leukemia, prostate)

    Phase II(416) 798-1200

    naptumomab estafenatox Active BiotechLund, Sweden

    (see also lung, pancreatic) Phase I completedwww.activebiotech.com

    Nexavar®sorafenib

    Bayer HealthCare PharmaceuticalsWayne, NJ

    renal cell carcinoma (adjuvant therapy)(see also breast, colorectal, head/neck, leukemia, liver, lung, multiple myeloma, ovarian, other)

    Phase III(888) 842-2937

    oncophage®vitespen(orphan Drug)

    AgenusLexington, MA

    renal cell carcinoma (Fast Track) Phase II(781) 674-4400

    OSI-027(TORC1/TORC2 inhibitor)

    OSI PharmaceuticalsFarmingdale, NY

    renal cancer(see also lymphoma)

    Phase II(631) 962-0600

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 27

    kidney CanCer

    product Name Sponsor Indication Development Status

    perifosine AEterna ZentarisBasking Ridge, NJ

    metastatic renal cancer(see also brain, colorectal, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

    Phase II(908) 626-5428

    Redectane®girentuximab I-124 companion diagnostic

    WilexMunich, Germany

    renal cancer (diagnosis) Phase III completedwww.wilex.de

    regorafenib Bayer HealthCare PharmaceuticalsWayne, NJ

    renal cancer(see also colorectal, lung, solid tumors, stomach)

    Phase II(888) 842-2837

    Rencarex®girentuximab(orphan Drug)

    WilexMunich, Germany

    clear cell renal cell carcinoma(Fast Track)

    Phase IIIwww.wilex.de

    ridaforolimus ARIAD PharmaceuticalsCambridge, MAMerckWhitehouse Station, NJ

    (see also breast, lung, prostate, sarcoma, other)

    Phase I(800) 672-6372

    SGN-75(vorsetuzumab mafodotin)

    Seattle GeneticsBothell, WA

    renal cancer(see also lymphoma)

    Phase I(425) 527-4000

    Sutent®sunitinib(orphan Drug)

    PfizerNew York, NY

    renal cell carcinoma (adjuvant therapy)

    Phase III(860) 732-5156

    tivantinib (ARQ 197)

    ArQuleWoburn, MADaiichi SankyoParsippany, NJ

    (see also colorectal, liver, lung, pancreatic, sarcoma, other)

    Phase II(781) 994-0300(973) 944-2600

    tivozanib(ASP4130/AV-951)

    Astellas Pharma USDeerfield, ILAVEO PharmaceuticalsCambridge, MA

    first-line renal cancer (see also breast, colorectal)

    --------------------------------------------------renal cancer(combination therapy)

    Phase III(800) 695-4321(617) 299-5000-------------------------------------------Phase I(800) 695-4321(617) 299-5000

    TKI258(dovitinib)

    Novartis PharmaceuticalsEast Hanover, NJ

    (see also breast, multiple myeloma, prostate, skin, other)

    Phase III(888) 669-6682

    torisel®temsirolimus(orphan Drug)

    PfizerNew York, NY

    renal cell carcinoma Phase III(860) 732-5156

    trebananib (AMG386)

    AmgenThousand Oaks, CA

    renal cancer(see also breast, colorectal, liver, ovarian, stomach, other)

    Phase II(800) 772-6436

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201228

    kidney CanCer

    product Name Sponsor Indication Development Status

    TVI-Kidney-1(cellular immunotherapyvaccine)

    TVAX BiomedicalLenexa, KS

    renal cell carcinoma Phase II completed(913) 492-2221

    veglin (VEGF antisense)

    VasGene TherapeuticsLos Angeles, CA

    (see also lung, skin) Phase I(323) 221-7818

    Votrient™pazopanib

    GlaxoSmithKlineRsch. Triangle Park, NC

    (see also ovarian, other) Phase III(888) 825-5249

    leukemia

    product Name Sponsor Indication Development Status

    ABIO-0501 (TALL104)

    Abiogen PharmaPisa, Italy

    chronic myeloid leukemia (CML) Phase IIwww.abiogen.it

    AC220(quizartinib)

    Ambit BiosciencesSan Diego, CAAstellas Pharma USDeerfield, IL

    second-line and third-line acute myeloid leukemia (AML) (monotherapy)(see also solid tumors)--------------------------------------------------acute lymphocytic leukemia (ALL) (combination therapy), first-line AML

    Phase II(858) 334-2100(800) 695-4321

    -------------------------------------------Phase I(858) 334-2100(800) 695-4321

    AC430(JAK2 inhibitor)

    Ambit BiosciencesSan Diego, CA

    Phase I(858) 334-2100

    Adcetris™brentuximab vedotin

    Millennium PharmaceuticalsCambridge, MASeattle GeneticsBothell, WA

    (see also lymphoma) Phase II(800) 390-5663(425) 527-4000

    AEG35156(XIAP inhibitor)

    Aegera TherapeuticsMontreal, Canada

    AML(see also lymphoma)--------------------------------------------------chronic lymphocytic leukemia (CLL)

    Phase II(514) 288-5532-------------------------------------------Phase I/II(514) 288-5532

    AFX-9154 Afecta PharmaceuticalsIrvine, CA

    in clinical trials(949) 253-4688

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 29

    leukemia

    product Name Sponsor Indication Development Status

    AGS-005 Argos TherapeuticsDurham, NC

    CLL Phase I/II(919) 287-6300

    ALD-151 AldagenDurham, NC

    Phase I(919) 484-2571

    ALXN6000(samalizumab)

    Alexion PharmaceuticalsCheshire, CT

    CLL(see also multiple myeloma)

    Phase I/II completed(203) 272-2596

    aminopterin Syntrix BiosystemsAuburn, WA

    ALL Phase II completed(253) 833-8009

    anti-CD22/CD19 mAb-toxinconjugate

    Abiogen PharmaPisa, Italy

    ALL Phase Iwww.abiogen.com

    AR-42 Arno TherapeuticsFlemington, NJ

    CLL(see also lymphoma, multiple myeloma)

    Phase I/II(862) 703-7170

    AR-67 Arno TherapeuticsFlemington, NJ

    myelodysplastic syndromes(see also brain, solid tumors)

    Phase II(862) 703-7170

    Arranon®nelarabine(orphan Drug)

    GlaxoSmithKlineRsch. Triangle Park, NC

    first-line ALL(see also lymphoma)--------------------------------------------------second-line ALL

    Phase III(888) 669-6682-------------------------------------------Phase I/II(888) 669-6682

    ARRY-520(KSP inhibitor)

    Array BioPharmaBoulder, CO

    AML(see also multiple myeloma, solid tumors)

    Phase II(877) 633-2436

    Arzerra®ofatumumab(orphan Drug)

    GlaxoSmithKlineRsch. Triangle Park, NC

    first-line CLL (combination therapy)(see also lymphoma)

    Phase III(888) 825-5249

    AT-101(oral pan Bcl-2 inhibitor)

    Ascenta TherapeuticsMalvern, PA

    CLL(see also brain, lung, lymphoma, prostate, stomach)

    Phase II(610) 408-0301

    AT-406/Debio-1143 Ascenta TherapeuticsMalvern, PADebiopharmLausanne, Switzerland

    AML(see also lymphoma)

    Phase I(610) 408-0301www.debiopharm.com

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201230

    leukemia

    product Name Sponsor Indication Development Status

    AT7519(CDK inhibitor)

    Astex PharmaceuticalsDublin, CA

    CLL(see also lymphoma, multiple myeloma, solid tumors)

    Phase II(925) 560-0100

    AT9283(aurora/Jak2 inhibitor)(orphan Drug)

    Astex PharmaceuticalsDublin, CA

    AML(see also lymphoma, multiple myeloma, solid tumors)

    Phase I/II(925) 560-0100

    AVL-292(Btk inhibitor)

    CelgeneSummit, NJ

    second-line CLL (combination therapy)(see also lymphoma, unspecified)

    Phase I(908) 673-9000

    AZD1208(Pim kinase inhibitor)

    AstraZenecaWilmington, DE

    AML Phase I(800) 236-9933

    bafetinib(orphan Drug)

    CytRx Los Angeles, CA

    second-line CLL (see also brain, prostate)--------------------------------------------------ALL, CML

    Phase II(310) 826-5648-------------------------------------------Phase I(310) 826-5648

    Bcl-2 inhibitor(ABT-199/GDC-0199)

    Abbott LaboratoriesAbbott Park, ILGenentechSouth San Francisco, CA

    CLL(see also lymphoma)

    Phase I(847) 937-6100(800) 626-3553

    belinostat Spectrum PharmaceuticalsHenderson, NV

    AML(see also colorectal, liver, lung, lymphoma, ovarian, other)

    Phase I/II(702) 835-6300

    BI-811283(aurora kinase B inhibitor)

    Boehringer IngelheimPharmaceuticalsRidgefield, CT

    AML(see also solid tumors)

    Phase I/II(800) 243-0127

    BI-836826 Boehringer IngelheimPharmaceuticalsRidgefield, CT

    CLL Phase I(800) 243-0127

    bosutinib PfizerNew York, NY

    previously treated CML application submitted(860) 732-5156

    cenersen(orphan Drug)

    EleosOmaha, NE

    AML Phase II completed(402) 393-3034

    Ceplene®histamine dihydrochloride injection(orphan Drug)

    EpiCeptTarrytown, NY

    AML application submitted(914) 606-3500

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 31

    leukemia

    product Name Sponsor Indication Development Status

    CLL immunotherapeutic vaccine MaxCyteGaithersburg, MD

    CLL Phase I/II(301) 944-1700

    Clolar®clofarabine injection (orphan Drug)

    GenzymeCambridge, MA

    AML (adults) Phase III(617) 252-7500

    CNDO-109(tumor activated NK cells)

    Coronado BiosciencesBurlington, MA

    AML Phase I(781) 238-6621

    CPX-351(cytarabine/daunorubicin)(orphan Drug)

    Celator PharmaceuticalsPrinceton, NJ

    AML Phase II(609) 243-0123

    CT-011 CureTechYavne, Israel

    second-line AML (combination therapy)(see also colorectal, lymphoma)

    Phase IIwww.curetechbio.com

    CWP232291 JW PharmaceuticalSeoul, South Korea

    AML Phase I

    Dacogen®decitabine

    EisaiWoodcliff Lake, NJ

    AML

    --------------------------------------------------pediatric AML

    application submitted(888) 422-4743-------------------------------------------Phase II(888) 422-4743

    danusertib Nerviano Medical SciencesNerviano, Italy

    CML Phase IIwww.nervianoms.com

    DCC-2036 Deciphera PharmaceuticalsLawrence, KS

    ALL, CML

    --------------------------------------------------AML

    Phase I/II(785) 830-2100-------------------------------------------Phase I(785) 830-2100

    DCDS-4501A GenentechSouth San Francisco, CA

    CLL(see also lymphoma)

    Phase I(800) 626-3553

    DCDT-2980S GenentechSouth San Francisco, CA

    recurrent CLL(see also lymphoma)

    Phase I(800) 626-3553

    elacyt™elacytarabine(orphan Drug)

    Clavis PharmaOslo, Norway

    late-stage AML(Fast Track)--------------------------------------------------early-stage AML

    Phase IIIwww.clavispharma.com-------------------------------------------Phase IIwww.clavispharma.com

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201232

    leukemia

    product Name Sponsor Indication Development Status

    elesclomol Synta PharmaceuticalsLexington, MA

    AML(see also lung, ovarian)

    Phase I(781) 274-8200

    entinostat Syndax PharmaceuticalsWaltham, MA

    (see also breast, colorectal, kidney, lung, lymphoma)

    Phase II(781) 419-1400

    epratuzumab(orphan Drug)

    ImmunomedicsMorris Plains, NJUCBAtlanta, GA

    ALL in children (combination therapy)(see also lymphoma)

    Phase II(973) 605-8200

    forodesine(orphan Drug)

    BioCryst PharmaceuticalsDurham, NC

    CLL(see also lymphoma)

    Phase II(919) 859-1302

    ganetespib (Hsp90i)

    Synta PharmaceuticalsLexington, MA

    ALL, AML, CML(see also breast, colorectal, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach)--------------------------------------------------myelodysplastic syndromes

    Phase I/II(781) 274-8200

    -------------------------------------------Phase I(781) 274-8200

    GNKG-168 SBI BiotechTokyo, Japan

    CLL Phase Iwww.sbibiotech.jp

    GRNVAC1(dendritic cell vaccine)

    Argos TherapeuticsDurham, NCGeronMenlo Park, CA

    AML(see also prostate)

    Phase II(650) 473-7700

    GS-1101(PI3K delta inhibitor)

    Gilead SciencesFoster City, CA

    second-line CLL (see also lymphoma)

    Phase III(800) 445-3235

    GSK2110183(protein kinase B inhibitor)

    GlaxoSmithKlineRsch. Triangle Park, NC

    (see also multiple myeloma) Phase II(888) 825-5249

    GSK2130579A(WT1 antigen-specific cancer immunotherapeutic)

    GlaxoSmithKlineRsch. Triangle Park, NC

    AML Phase II(888) 825-5249

    GVAX® Leukemiacancer vaccine(orphan Drug)

    BioSante PharmaceuticalsLincolnshire, IL

    AML, CML Phase II(847) 478-0500

    HuM195-Ac-225(lintuzumab Ac-225)

    Actinium PharmaceuticalsNewark, NJ

    AML Phase I(973) 344-6500

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 33

    leukemia

    product Name Sponsor Indication Development Status

    HuM195-Bi-213(lintuzumab Bi-213)

    Actinium PharmaceuticalsNewark, NJ

    AML Phase I/II(973) 344-6500

    HuM195/rGel(lintuzumab-gelonin conjugate)

    Targa TherapeuticsSan Diego, CA

    AML, CML, myelodysplasticsyndromes

    Phase I(858) 483-6600

    ibrutinib(PCI-32765)

    Janssen BiotechHorsham, PAPharmacyclicsSunnyvale, CA

    CLL(see also lymphoma, multiple myeloma)

    Phase I/II(800) 526-7736(408) 774-0330

    imatinib sublingual Kedem PharmaceuticalsMesa, AZ

    CML in clinical trials(604) 324-4244

    imetelstat GeronMenlo Park, CA

    CLL(see also breast, lung, multiple myeloma)

    Phase I/II(650) 473-7700

    Imprime pGG® BiotheraEagan, MN

    CLL(see also colorectal, lung, skin)

    Phase I/II(651) 675-0300

    INNO-305(WT-1 vaccine)

    CytRxLos Angeles, CA

    AML, myelodysplastic syndromes(see also solid tumors)

    Phase I(310) 826-5648

    inotuzumab ozogamicin PfizerNew York, NY

    ALL(see also lymphoma)

    Phase I(860) 732-5156

    ISF35(recombinant immunotherapeutic vaccine)

    MemgenSan Diego, CA

    CLL (monotherapy)(see also lymphoma)--------------------------------------------------refractory metastatic CLL (combination therapy)

    Phase II(858) 524-5400-------------------------------------------Phase I(858) 524-5400

    JNJ-26481585(quisinostat)

    Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

    myelodysplastic syndromes, metastatic leukemia(see also lymphoma)

    Phase I(800) 817-5286

    JVRS-100(lipid-DNA complex vaccine)

    Colby PharmaceuticalSan Jose, CA

    Phase I(650) 333-3152

    KX2-391 Kinex PharmaceuticalsBuffalo, NY

    AML in the elderly(see also prostate)

    Phase I(716) 898-8626

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201234

    leukemia

    product Name Sponsor Indication Development Status

    LBH589 (panobinostat)

    Novartis PharmaceuticalsEast Hanover, NJ

    ALL, AML, myelodysplastic syndromes(see also kidney, multiple myeloma, prostate, solid tumors)

    Phase II(888) 669-6682

    LDE225(erismodegib)

    Novartis PharmaceuticalsEast Hanover, NJ

    CML (combination therapy)(see also pancreatic, solid tumors, skin)

    Phase I(888) 669-6682

    lestaurtinib(orphan Drug)

    CephalonFrazer, PA

    AML Phase II(610) 344-0200

    leukemia DNA vaccine Inovio PharmaceuticalsBlue Bell, PAUniversity of SouthamptonSouthampton, United Kingdom

    AML, CML Phase II(877) 446-6846

    LG740(activated T-cells)

    LentigenGaithersburg, MDUniversity of PennsylvaniaPhiladelphia, PA

    ALL, B-cell prolymphocytic leukemia, CLL(see also lymphoma)

    Phase I(301) 527-4200

    LOR-2040(orphan Drug)

    Lorus TherapeuticsToronto, Canada

    AML (combination therapy)(see also breast, colorectal, kidney, prostate)--------------------------------------------------CML, myelodysplastic syndromes

    Phase II(416) 798-1200

    -------------------------------------------Phase I (416) 798-1701

    lurbinectedin PharmaMarMadrid, Spain

    (see also solid tumors) Phase Iwww.pharmamar.com

    Marqibo®vincristine liposomal(orphan Drug)

    Talon TherapeuticsSan Mateo, CA

    relapsed or refractory Philadelphia chromosome-negative ALL (Fast Track)(see also lymphoma, skin, other)--------------------------------------------------ALL in the elderly (Fast Track)

    application submitted(650) 588-6404

    -------------------------------------------Phase III(650) 588-6404

    milatuzumab ImmunomedicsMorris Plains, NJ

    CLL (monotherapy)(see also lymphoma, multiple myeloma)

    Phase I/II(973) 605-8200

    MK-7956(dinaciclib)(orphan Drug)

    MerckWhitehouse Station, NJ

    CLL(see also lymphoma)

    Phase II(800) 672-6372

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 35

    leukemia

    product Name Sponsor Indication Development Status

    MK-8242 MerckWhitehouse Station, NJ

    AML(see also solid tumors)

    Phase I(800) 672-6372

    mocetinostat(MGCD0103, HDAC inhibitor)

    MethylGeneMontreal, Canada

    CLL(see also lymphoma, solid tumors)

    Phase II completed(514) 337-3333

    Mozobil®plerixafor

    GenzymeCambridge, MA

    AML Phase I(617) 252-7500

    navitoclax(ABT-263)

    Abbott LaboratoriesAbbott Park, IL

    first-line CLL (combination therapy)(see also lung, lymphoma)--------------------------------------------------CLL, lymphoid leukemia

    Phase II(847) 937-6100-------------------------------------------Phase I(847) 937-6100

    Nexavar®sorafenib

    Bayer HealthCare PharmaceuticalsWayne, NJ

    AML, myelodysplastic syndromes(see also breast, colorectal, head/neck, kidney, liver, lung, multiple myeloma, ovarian, other)

    Phase I/II(888) 842-2937

    obatoclax(orphan Drug)

    CephalonFrazer, PA

    CLL(see also lung, lymphoma, multiple myeloma)

    Phase I/II completed(610) 344-0200

    obinutuzumab(GA101/RG7159)

    Biogen IdecWeston, MAGenentechSouth San Francisco, CA

    first-line CLL (combination therapy)(see also lymphoma)

    Phase III(781) 464-2000(800) 626-3553

    omapro™omacetaxine(orphan Drug)

    CephalonFrazer, PA

    second-line CML(see also solid tumors)--------------------------------------------------AML, myelodysplastic syndromes

    application submitted(610) 344-0200-------------------------------------------Phase II(610) 344-0200

    ON 013105 Onconova TherapeuticsNewtown, PA

    ALL(see also lymphoma)

    Phase I(267) 759-3680

    oral azacitidine(orphan Drug)

    CelgeneSummit, NJ

    myelodysplastic syndromes(Fast Track) (see also lung, lymphoma, solid tumors)--------------------------------------------------AML, CML

    Phase II(908) 673-9000

    -------------------------------------------Phase I(908) 673-9000

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201236

    leukemia

    product Name Sponsor Indication Development Status

    oral clofaribine GenzymeCambridge, MA

    myelodysplastic syndromes Phase I(617) 252-7500

    OVI-123(orphan Drug)

    OncoVista Innovative TherapiesSan Antonio, TX

    TdT-positive leukemia Phase I(210) 677-6000

    OXi4503 OXiGENESouth San Francisco, CA

    AML, myelodysplastic syndromes Phase I(650) 635-7000

    perifosine AEterna ZentarisBasking Ridge, NJ

    refractory metastatic CLL(see also brain, colorectal, kidney, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

    Phase II(908) 626-5428

    PKC412(midostaurin)

    Novartis PharmaceuticalsEast Hanover, NJ

    AML Phase III(888) 669-6682

    PLX3397(CSF-1R kinase inhibitor)

    PlexxikonBerkeley, CA

    recurrent or refractory AML(see also brain, lymphoma, solid tumors)

    Phase I/II(510) 647-4000

    ponatinib(orphan Drug)

    ARIAD PharmaceuticalsCambridge, MA

    Philadelphia-positive ALL, CML

    --------------------------------------------------AML

    Phase II(617) 494-0400-------------------------------------------Phase I(617) 494-0400

    PR104 ProactaLa Jolla, CA

    AML Phase I/II(858) 642-0386

    Revlimid®lenalidomide(orphan Drug)

    CelgeneSummit, NJ

    CLL, myelodysplastic syndromes(see also lymphoma)

    Phase III(908) 673-9000

    rigosertib(orphan Drug)

    Onconova TherapeuticsNewtown, PA

    myelodysplastic syndromes (intravenous)(see also lymphoma, ovarian, pancreatic)--------------------------------------------------CLL

    --------------------------------------------------AML

    --------------------------------------------------myelodysplastic syndromes (oral)

    Phase III(267) 759-3680

    -------------------------------------------Phase II(267) 759-3680-------------------------------------------Phase I/II(267) 759-3680-------------------------------------------Phase I(267) 759-3680

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 37

    leukemia

    product Name Sponsor Indication Development Status

    sapacitabine (CYC682)(orphan Drug)

    Cyclacel PharmaceuticalsBerkeley Heights, NJ

    first-line AML (see also lung, solid tumors)--------------------------------------------------CLL (combination therapy),myelodysplastic syndromes

    Phase III(908) 517-7330-------------------------------------------Phase II(908) 517-7330

    SB989 (pracinostat)

    S*BIOOakland, CA

    myelodysplastic syndromes(see also solid tumors, other)

    Phase I(650) 730-2860

    SB1518 (pacritinib)

    S*BIOOakland, CA

    myelodysplastic syndromes

    --------------------------------------------------myeloid leukemia

    Phase II(650) 730-2860-------------------------------------------Phase I/II(650) 730-2860

    SF1126(orphan Drug)

    Semafore PharmaceuticalsIndianapolis, IN

    CLL(see also multiple myeloma, solid tumors)

    Phase I(317) 876-3075

    SGI110(DNMT inhibitor)

    Astex PharmaceuticalsDublin, CA

    AML, myelodysplastic syndromes Phase I/II(925) 560-0100

    SL-401(recombinant fusion protein)(orphan Drug)

    Stemline TherapeuticsNew York, NY

    AML, myelodysplastic syndromes Phase I/II(646) 502-2310

    tamibarotene(orphan Drug)

    CytRxLos Angeles, CA

    acute promyelocytic leukemia (APL) (Fast Track)(see also lung)--------------------------------------------------APL (combination therapy)

    Phase II(310) 826-5648

    -------------------------------------------Phase I(310) 826-5648

    tarceva®erlotinib

    GenentechSouth San Francisco, CAOSI OncologyFarmingdale, NY

    myelodysplastic syndromes(see also brain, breast, head/neck, liver, lung, other)

    Phase II(800) 626-3553(631) 962-0600

    tasigna®nilotinib(orphan Drug)

    Novartis PharmaceuticalsEast Hanover, NJ

    CML (adolescents and children), ALL (adolescents and children)(see also skin, stomach)

    Phase II(888) 669-6682

    temodar®temozolomide

    MerckWhitehouse Station, NJ

    AML(see also lung)

    Phase II(800) 672-6372

    TH-302 Threshold PharmaceuticalsSouth San Francisco, CA

    (see also brain, multiple myeloma, pancreatic, sarcoma)

    Phase I(650) 474-8200

    thiarabine Access PharmaceuticalsDallas, TX

    (see also lymphoma) Phase I/II(215) 904-5100

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201238

    leukemia

    product Name Sponsor Indication Development Status

    TL-32711(birinapant)

    TetraLogic PharmaceuticalsMalvern, PA

    AML(see also solid tumors)

    Phase I/II(610) 889-9900

    tosedostat(orphan Drug)

    Chroma TherapeuticsOxon, United Kingdom

    AML Phase IIwww.chromatherapeutics.com

    trametinib GlaxoSmithKlineRsch. Triangle Park, NC

    relapsed or refractory leukemia(see also brain, lung, lymphoma, multiple myeloma, pancreatic, skin)

    Phase III(888) 825-5249

    treanda®bendamustine

    CephalonFrazer, PA

    ALL in children, AML in children(see also lymphoma, multiple myeloma)

    Phase I/II(610) 344-0200

    treosulfan MedacWedel, Germany

    ALL, AML, myelodysplastic syndromes

    Phase IIwww.medac.de

    TRU-016(humanized anti-CD37 therapeutic)

    Emergent BioSolutionsRockville, MD

    CLL(see also lymphoma)

    Phase II(301) 795-1800

    Velcade®bortezomib

    Millennium PharmaceuticalsCambridge, MA

    second-line T-cell prolymphocytic leukemia (see also lymphoma, other, cancer-related)

    Phase II(800) 390-5663

    veltuzumab(orphan Drug)

    ImmunomedicsMorris Plains, NJ

    CLL(see also lymphoma)

    Phase I/II(973) 605-8200

    Vidaza®azacitidine(orphan Drug)

    CelgeneSummit, NJ

    AML in the elderly(see also lymphoma)

    Phase III(908) 673-9000

    vosaroxin(orphan Drug)

    Sunesis PharmaceuticalsSouth San Francisco, CA

    second-line AML(Fast Track)(see also ovarian)--------------------------------------------------AML in the elderly

    Phase III(650) 266-3739

    -------------------------------------------Phase II(650) 266-3739

    XmAb® 5574(MOR208, anti-CD19 mAb)

    MorphoSysPlanegg, GermanyXencorMonrovia, CA

    recurrent CLL Phase Iwww.morphosys.com(626) 305-5900

    Zolinza®vorinostat

    MerckWhitehouse Station, NJ

    AML, myelodysplastic syndromes(see also breast, lung, lymphoma, multiple myeloma, other)

    Phase II(800) 672-6273

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 39

    liver CanCer

    product Name Sponsor Indication Development Status

    ALN-VSP Alnylam PharmaceuticalsCambridge, MA

    Phase I(617) 551-8200

    bavituximab Peregrine PharmaceuticalsTustin, CA

    (see also lung, pancreatic) Phase I/II(715) 508-6000

    BAY 86-9766(MEK inhibitor)

    Ardea BiosciencesSan Diego, CABayer HealthCare PharmaceuticalsWayne, NJ

    first-line liver cancer (combination therapy)(see also pancreatic)

    Phase II(888) 842-2937

    belinostat Spectrum PharmaceuticalsHenderson, NV

    inoperable/unresectable liver cancer(see also colorectal, leukemia, lung, lymphoma, ovarian, other)

    Phase I/II(702) 835-6300

    BIIB 022 Biogen IdecCambridge, MA

    (see also lung) Phase I completed(617) 679-2000

    brivanib(VEGFR/FGFR kinase inhibitor)

    Bristol-Myers SquibbPrinceton, NJ

    first-line liver cancer, liver cancer (TACE)(see also colorectal, sarcoma)

    Phase III(800) 332-2056

    cixutumumab(LY3012217/IMC-A12)

    Eli LillyIndianapolis, INImCloneBridgewater, NJ

    (see also lung) Phase II(800) 545-5979

    darinaparsin(ZIO-101)

    ZIOPHARM OncologyNew York, NY

    (see also lymphoma, multiple myeloma, solid tumors)

    Phase II(646) 214-0700

    DC Bead®doxorubicin-eluting beads

    Bayer HealthCare PharmaceuticalsWayne, NJBiocompatiblesSurrey, United Kingdom

    Phase II(888) 842-2937

    E7050 EisaiWoodcliff Lake, NJ

    (see also brain, head/neck, skin, solid tumors, stomach)

    Phase I/II(888) 422-4743

    foretinib(GSK1363089)

    GlaxoSmithKlineRsch. Triangle Park, NC

    (see also head/neck, kidney, lung) Phase I(888) 825-5249

    ganetespib (Hsp90i)

    Synta PharmaceuticalsLexington, MA

    (see also breast, colorectal, leukemia, lung, multiple myeloma, pancreatic, prostate, skin, stomach)

    Phase II(781) 274-8200

    Inlyta®axitinib

    PfizerNew York, NY

    (see also kidney, other) Phase II(860) 732-5156

    irinotecan eluting beads Biocompatibles InternationalSurrey, United Kingdom

    liver metastases from colorectal cancer

    Phase IIwww.biocompatibles.com

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201240

    liver CanCer

    product Name Sponsor Indication Development Status

    JX-594 (pexastimogene devacirepvec)(orphan Drug)

    Jennerex BiotherapeuticsSan Francisco, CA

    (see also colorectal) Phase II(415) 281-8886

    lansoprazole (orphan Drug)

    Apricus BiosciencesSan Diego, CA

    first-line liver cancer Phase II(858) 220-8041

    linifanib Abbott LaboratoriesAbbott Park, IL

    first-line liver cancer (monotherapy)(see also breast, colorectal, kidney, lung)

    Phase III(847) 937-6100

    mapatumumab Human Genome SciencesRockville, MD

    liver cancer (combination therapy)(see also lung, multiple myeloma)

    Phase II(301) 309-8504

    MB07133(HepDirect HepB inhibitor)

    Ligand PharmaceuticalsLa Jolla, CA

    inoperable/unresectable liver cancer Phase I/II completed(858) 550-7500

    melphalan drug delivery system Delcath SystemsNew York, NY

    inoperable/unresectable liver cancer application submitted(212) 489-2100

    muparfostat (PI-88) Progen PharmaceuticalsQueensland, Australia

    liver cancer (Fast Track)(see also skin)

    Phase IIIwww.progen.com.au

    Nexavar®sorafenib(orphan Drug)

    Bayer HealthCare PharmaceuticalsWayne, NJ

    heptocellular carcinoma (adjuvant therapy)(see also breast, colorectal, head/neck, kidney, leukemia, lung, multiple myeloma, ovarian, other)

    Phase III(888) 842-2937

    NV-1020 CatherexPhiladelphia, PA

    Phase I/II completed

    OBP-301 Oncolys BiopharmaTokyo, Japan

    (see also breast, head/neck, lung) Phase Iwww.oncolys.com

    PEG arginine deiminase (ADI-PEG 20)

    Polaris PharmaceuticalsSan Diego, CA

    hepatocellular carcinoma(see also prostate, skin, other)

    Phase III(858) 452-6688

    PHY906 PhytoCeuticaNew Haven, CT

    (see also colorectal, pancreatic, cancer-related)

    Phase I/II completed(203) 777-3462

    PV-10(rose bengal sodium)(orphan Drug)

    Provectus PharmaceuticalsKnoxville, TN

    liver cancer, liver metastases(see also skin)

    Phase I(866) 594-5999

    RG7686 RocheNutley, NJ

    metastatic liver cancer(combination therapy)

    Phase II(973) 235-5000

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 41

    liver CanCer

    product Name Sponsor Indication Development Status

    tarceva®erlotinib

    GenentechSouth San Francisco, CAOSI PharmaceuticalsFarmingdale, NY

    first-line inoperable/unresectable liver cancer (combination therapy)(see also brain, breast, head/neck, leukemia, lung, other)--------------------------------------------------second-line liver cancer (combination therapy)

    Phase III(800) 626-3553(631) 962-0600

    -------------------------------------------Phase II(800) 626-3553(631) 962-0600

    TGF-ß R1 inhibitor(LY2157299)

    Eli LillyIndianapolis, IN

    (see also brain) Phase II(800) 545-5979

    thermoDox®doxorubicin liposomal(orphan Drug)

    CelsionLawrenceville, NJ

    first-line inoperable/unresectable liver cancer (Fast Track)(see also breast, colorectal)

    Phase III(609) 896-9100

    tigatuzumab(anti-DR5 antibody)

    Daiichi SankyoParsippany, NJ

    (see also breast, colorectal, lymphoma, ovarian, pancreatic)

    Phase II(973) 944-2600

    tivantinib (ARQ 197) ArQuleWoburn, MADaiichi SankyoParsippany, NJ

    second-line liver cancer (see also colorectal, kidney, lung, pancreatic, sarcoma, other)--------------------------------------------------liver cancer (combination therapy)

    Phase II(781) 994-0300(973) 944-2600------------------------------------------Phase I(781) 994-0300(973) 944-2600

    trebananib (AMG386)

    AmgenThousand Oaks, CA

    (see also breast, colorectal, kidney, ovarian, stomach, other)

    Phase II(800) 772-6436

    Xeloda®capecitabine

    GenentechSouth San Francisco, CA

    biliary cancer (combination therapy)(see also brain, colorectal, stomach)

    Phase II(800) 626-3553

    Zadaxin®thymalfasin alfa 1(orphan Drug)

    SciClone PharmaceuticalsFoster City, CA

    (see also skin) Phase II/III(650) 358-3456

    Medicines in Development for Cancer

  • Medicines in Development Cancer 201242

    lung CanCer

    product Name Sponsor Indication Development Status

    Abraxane®albumin-bound paclitaxel

    CelgeneSummit, NJ

    first-line non-small-cell lung cancer (NSCLC)(see also bladder, breast, ovarian, pancreatic, skin)

    application submitted(908) 673-9000

    ABT-888 (veliparib)(PARP inhibitor)

    Abbott LaboratoriesAbbott Park, IL

    NSCLC(see also brain, breast, colorectal, lymphoma, ovarian, prostate, skin, other)

    Phase II(847) 937-6100

    AC480(pan-HER inhibitor)

    Ambit BiosciencesSan Diego, CA

    NCSLC(see also brain, breast)

    Phase I(858) 334-2100

    Actimid®pomalidomide

    CelgeneSummit, NJ

    small-cell lung cancer (SCLC)(see also lymphoma, multiple myeloma, pancreatic)

    Phase I/II(908) 673-9000

    afatinib(BIBW2992)

    Boehringer IngelheimPharmaceuticalsRidgefield, CT

    first-line NSCLC(see also brain, breast, head/neck)--------------------------------------------------second-line NSCLC (Fast Track)

    Phase III(800) 243-0127-------------------------------------------Phase II/III(800) 243-0127

    Alimta®pemetrexed

    Eli LillyIndianapolis, IN

    first-line and maintenance NSCLC Phase III(800) 545-5979

    AMG888/U3-1287(anti-HER3 antibody)

    AmgenThousand Oaks, CADaiichi SankyoParsippany, NJ

    NSCLC Phase II(800) 772-6436(973) 944-2600

    amrubicin(orphan Drug)

    CelgeneSummit, NJ

    SCLC (Fast Track)(see also breast)--------------------------------------------------first-line SCLC

    Phase III(908) 673-9000-------------------------------------------Phase II(908) 673-9000

    amuvatinib(MP470)

    Astex PharmaceuticalsDublin, CA

    SCLC (combination therapy)(see also lymphoma)

    Phase II(925) 560-0100

    anti-PD1 (BMS-936558)

    Bristol-Myers SquibbPrinceton, NJ

    (see also kidney, skin) Phase II(800) 332-2056

    AP26113 ARIAD PharmaceuticalsCambridge, MA

    NSCLC Phase I(617) 494-0400

    apricoxib(TG01)

    Tragara PharmaceuticalsSan Diego, CA

    second-line NSCLC (combination therapy)(see also pancreatic)

    Phase II(858) 350-6900

    Medicines in Development for Cancer

  • Medicines in Development Cancer 2012 43

    lung CanCer

    product Name Sponsor Indication Development Status

    astuprotimut-R(MAGE-A3 antigen-specific cancer immunotherapeutic)

    GlaxoSmithKlineRsch. Triangle Park, NC

    adjuvant NSCLC (see also skin)

    Phase III(888) 825-5249

    AT-101(oral pan Bcl-2 inhibitor)

    Ascenta TherapeuticsMalvern, PA

    NSCLC (combination therapy), SCLC (combination therapy) (see also brain, leukemia, lymphoma, prostate, stomach)

    Phase II(610) 408-0301

    AUY922(Hsp90 inhibitor)

    Novartis PharmaceuticalsEast Hanover, NJ

    third-line NSCLC(see also breast, colorectal, multiple myeloma, stomach)--------------------------------------------------second-line late-stage NSCLC(combination therapy)

    Phase II(888) 669-6682

    -------------------------------------------Phase I/II(888) 669-6682

    Avastin®bevacizumab

    GenentechSouth San Francisco, CA

    adjuvant NSCLC (see also brain, breast, colorectal, ovarian, other)

    Phase III(800) 626-3553

    bavituximab Peregrine PharmaceuticalsTustin, CA

    first-line NSCLC, second-line NSCLC(see also liver, pancreatic)

    Phase II(715) 508-6000

    belinostat Spectrum PharmaceuticalsHenderson, NV

    mesothelioma(see also colorectal, leukemia, liver, lymphoma, ovarian, other)--------------------------------------------------NSCLC