cco gastric cancer ll slides

8/19/2019 CCO Gastric Cancer LL Slides

1/63

Expert Insight on Optimal

Treatment Selection for Patients

With Advanced Gastric Cancer

This program is supported by an educational grant from Lilly.


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About These Slides

Please feel free to use, update, and share some or allof these slides in your noncommercial presentationsto colleagues or patients

When using our slides, please retain the sourceattribution:

These slides may not be published, posted online, or

used in commercial presentations without permission.Please contact [email protected] fordetails

Slide credit: clinicaloptions.com

mailto:[email protected]://www.clinicaloptions.com/oncologyhttp://www.clinicaloptions.com/oncologymailto:[email protected]


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Core acult!

Axel Grothe!" #$Professor , Oncologyayo !linic"ochester, innesota

$avid %& Ilson" #$" Ph$Professor of MedicineWeill !ornell edical !ollege Attending Physician

emorial Sloan #ettering !ancer !enter $ew %or&, $ew %or&


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acult! $isclosures

Axel Grothe!" #$" has no real or apparent conflicts ofinterest to report.

$avid Ilson" #$" Ph$" has disclosed that he has

recei'ed consulting fees from (mgen, Lilly, $o'artis,and Taiho and funds for research support from (mgenand Lilly.


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Agenda

Program O'er'iew

!hoosing Optimal )irst*line Treatment for Patients With (d'anced or etastatic +astric !ancer

Selecting ffecti'e Sal'age Therapy for Patients With (d'anced or etastatic +astric !ancer Who Progress on)irst or Later Lines of Treatment

Targeted Therapies for the anagement of (d'anced oretastatic +astric !ancer

Promising -n'estigational (pproaches in etastatic or (d'anced +astric !ancer

!losing "emar&s, uestion and (nswer Session


http://www.clinicaloptions.com/oncologyhttp://www.clinicaloptions.com/oncology


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Postoperati'e "T ? chemotherapy 4S7A0B

8 Treatment: 1*)CLD ? "T 4-$T*300 study7

8 036 E 1*yr OS> F": 3.2

Preop and postop chemo 4#7 without "TA5B

8 Treatment: !) 4(+-! study7 8 0G6 E 1*yr OS> F": 3.21

Postop chemo 4(sia7: 5 trials, 5333 pts, F": 3.

Sur'i'al impro'ements with all approaches similar, modest

Ad-uvant Therap! in Gastric Cancer

Improves OS

0. Smalley S", et al. = !lin Oncol. 5305>G3:5G52*5GGG.

5. !unningham G11:00*53.

G. Sasa&o , et al. = !lin Oncol. 5300>59:/G;2*/G9G./. $oh SF, et al. Lancet Oncol. 530/>01:0G;9*0G9.



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Esophageal and GE. Adenocarcinoma'

Ad-uvant Therap!

T5*G or $?: Something more than surgery aloneshould be done

Perioperati'e !), preoperati'e !) impro'es OS in

some but not all trials 8 (+-! 4perioperati'e !)7: 0G6 E OS at 1 yrs> F":

3.21 4esophageal, 053 pts7, no increase in "3resectionA0B

8 ))! F": 3.94esophageal cancer, 0;3 pts7 same as (+-!, noepirubicin, increase in "3 resectionA5B

0. !unningham G11:00*53.

5. %chou , et al. = !lin Oncol. 5300>59:0201*0250. Slide credit: clinicaloptions.com



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Esophageal Adenocarcinoma' Consensus

on Ad-uvant Therap!

Preop chemotherapy

8 "! OO*5 4!)7:$ I ;35A0B

81*yr update: 6 OSincrease 's resectionalone

8 S -$T*00G 4!)7: $ I//3A5B

8 $o impact on OS or anyendpoint, including "3rate

"! OO1 4!) 's !J7:$ I 933, S stagedAGB

8 !) H 5 's !J H /:eKui'alent

8 $o sur'i'al benefit withadditional cycles of !J

8 Poor rates of "3resection: 36 to 6

8 52:135*132.

5. #elsen GG9:0929*09;/.

G. !unningham


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'an Fagen P, et al. $ ngl = ed. 5305>G:532/*532;.

Preop C3T 4 Surger! vs Surger! Alone for

Esophageal or .unctional Cancer

PaclitaHel 13 mgCm5 ? carboplatin (! 5 on


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Preop C3T 4 Surger! vs Surger! Alone for

Esophageal or .unctional Cancer' OS

"3 resection increased from96 wCsurgery alone to 956

1*yr OS: /26 's G/6 withsurgery alone

8 SKuamous F": 3./1G

8 (deno F": 3.2G5

Pathologic !" with !"T ?surgery

8 SKuamous: /96

8 (denocarcinoma: 5G6

!onsidered a new standard ofcare

'an Fagen P, et al. $ ngl = ed. 5305>G:532/*532;.

0.3

3.;

3.

3./

3.5

3 05 5/ G /; 3#os

P r o

p o r t i o n S u r v i v i n g

P I .33G

!"T ? surgery

Surgery alone

3

0.3

3.;

3.

3./

3.5

3 05 5/ G /; 3#os

P r o p o r t i o n S u r v i v i n g

3

OS b! Treatment

OS b! Tumor T!pe and

Treatment

S!!, !"T ? surgery

(!, !"T ? surgery

(!, surgery alone

S!!, surgery alone

(!, P I .3/9

S!!, P I .300



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irst6line Chemotherap!


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irst6line Therap! 3ecommendations

Preferred regimens

8 )luoropyrimidine ? cisplatin4category 07 or oHaliplatin 45(7

8

8 !) 4category 07

8 )luorouracil ? irinotecan4category 07

F"5*positi'e disease

8 TrastuMumab ? cisplatinCfluoropyrimidine 4category 07

8 TrastuMumab ? other agentsN

457

Other regimens

8 PaclitaHel ? cis* or carboplatin4category 5(7

8


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Advanced Esophagogastric Cancer

Chemotherap!' Which 3egimen to (se7

06$rug 3egimens )6$rug 3egimens

Oxali'

EO5 orEO8+9

Cape'

EC5 orEO58+9 $C8)9

EC809 5P819 :O8,9 O:I3I8/9

S6+Cis

829

$ /;9 10G 550 05 03 005 539 G31O"",6

// /1 G2 /1 / G1 G9 1/

TTP,mo

.2 .1 1. 2./ 1. 1.; 1.G .3

OS,mo 03./ 03.9 9.5 ;.9 03.1 03.2 9.1 0G.3

0. !unningham G1;:G*/. 5. Dan !utsem , et al.

= !lin Oncol. 533>5/:/990*/992. G. Webb (, et al. = !lin Oncol. 0992>01:50*

52./. #ang %#, et al. (nn Oncol. 5339>53:*2G. 1. (l*atran S, et al. =

!lin Oncol. 533;>5:0/G1*0//5. . +uimbaud ", et al. = !lin Oncol.

530/>G5:G153*G15. 2. #oiMumi W, et al. Lancet Oncol. 533;>9:501*550. Slide credit: clinicaloptions.com



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Phase III TA50), Stud!' $ocetaxel;

Cisplatin;,6( vs Cisplatin;,6(

Primary endpoint: TTP from / mos

Secondary endpoints: OS, "", safety, oL, clinical benefit

Pts with ad'anced gastric

cancer and no pre'iouspalliati'e chemotherapy

4$ I /127

$C

$ocetaxel 21 mgCm5 -D o'er 0 hr on 5/:/990*/992. Slide credit: clinicaloptions.com



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$C vs C in Advanced Gastric Cancer


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$C vs C in Advanced Gastric Cancer


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$ I /0

8 0CG +=, 5CG gastric

O"": G96 's G;6

edian P)S:1.G 's 1.; mos

edian OS:9.1 's 9.2 mos

TT), toHicity fa'oredfirst*line )OL)-"-o'er !J

$oes Epirubicin Add An!thing in

Advanced GE Cancer7 O:I3I vs EC5

+uimbaud ", et al. = !lin Oncol. 530/>G5:G153*G15

Time to Treatment ailure


0.3

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EC5

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Phase III' ,6(;:@ 4 Either Oxaliplatin or

Cisplatin in Adv Gastric Cancer

$ I 553

Treatment: 1*)CLD K5wplus either

8 OHaliplatin ;1 mgCm5 4)LO7 8 !isplatin 13 mgCm5 4)LP7

Primary endpoint: P)S

OHaliplatin noninferior to cisplatin

-n pts R 1 yrs, oHaliplatin showed superior P)S and OS

:O :P P @alue

edian P)S,mos

1.; G.9 .322

O"" 4-TT7, 6 /5 0 .305

(l*atran S, et al. = !lin Oncol. 533;>5:0/G1*0//5.



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(l*atran S, et al. ur = !ancer. 530G>/9:;G1*;/5. Slide credit: clinicaloptions.com

,6(;:@ 4 Oxaliplatin D $ocetaxel in Adv

Gastric Cancer' 3esults in Pts /, Frs

$ I 0/G pts> median age: 23 yrs

Treatment: )LO 's )LOT

8 1*)CoHaliplatin docetaHel

O"": /96 with )LOT 's 5;6 with )LO 4P I .307

P)S: 9 mos with )LOT 's 2 mos with )LO 4P I .3297

OS: 02.G mos with )LOT 's 0/.1 mos with )LO 4P I 3.G97

ToHicity: ;56 grade GC/ (s with )LOT 's G96 with )LO>worse oL with )LOT

ore toHicity with no sur'i'al benefit for )LOT 's )LO in pts R1 yrs



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!unningham G1;:G*/.

3EA:6) Trial' Capecitabine vs ,6("

Oxaliplatin vs Cisplatin

5 H 5 randomiMation, ; cycles

EC 4n I 5/97pirubicin 13 mgCm5 -D KGw

!isplatin 3 mgCm5 -D KGw

1*) 533 mgCm5Cd -D gi'en

continuously

EO 4n I 5G17pirubicin 13 mgCm5 -D KGw

OHaliplatin 0G3 mgCm5 -D KGw

1*) 533 mgCm5

Cd -D gi'encontinuously

EC5 4n I 5/07pirubicin 13 mgCm5 -D KGw

!isplatin 3 mgCm5 -D KGw

!apecitabine 51 mgCm5 PO -<

continuously

EO5 4n I 5G97pirubicin 13 mgCm5 -D KGw

OHaliplatin 0G3 mgCm5 -D KGw

!apecitabine 51 mgCm5

PO -<continuously


$oninferiority of J o'er ) and O o'er !with 0*yr sur'i'al of G16 40*side of 167



22/63


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0

53

3EA: )' OS" Cisplatin vs Oxaliplatin

!unningham G1;:G*/. Slide credit: clinicaloptions.com

033

;3

3

/3

3 3 5 G

/93

/2/

0;2

09;

/0

/;

03

03

!isplatin

OHaliplatin

Pts at 3is" n

Frs Since 3andomiation

P r o b a b i l i t ! o f S u r v i v a l


24/63

Parent $C vs #odified $C in #etastatic

Gastric Cancer

"andomiMed, multicenter phase -- trial

Primary endpoint: safety and *mo P)S

Secondary endpoints: response, median P)S, OS, 0* and 5*yr sur'i'al

Slide credit: clinicaloptions.comShah (, et al. = !lin Oncol. 5301>Apub ahead of printB.

Parent $C

$ocetaxel 21 mgCm5 -D o'er 0 hr on


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Gastric Cancer' Efficac!


Parameter m$C

,1=

Parent$C

0+=

edian cycles,n 4range7

1.24G./*.;7

/.345.1*.G7

*mo P)S, 6 G 1G

*mo TT), 6 1 10

0*yr OS, 6 G 11

5*yr OS, 6 G3 05

O"" 4!" ?P"7, 6 /9 GG

0.3

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#os

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m

Parent

9.2

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.5

#edian

PS" #os P

m

Parent

0;.;

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#edian

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26/63


Gastric Cancer' Grade 0;1 AEs of Interest

%ematologicAE" m$C

,1=

Parent$C

0+=

(nemia 00 G9

Leu&openia 55 /;

$eutropenia4afebrile7

1 /1

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9 0


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,1=

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0+=

(noreHia 3 0G

$ausea 5 5G

Domiting 5 09

)atigue 00 0G

$europathy / 0G

Fypo*

phosphatemia

0G G5

Fypo&alemia 9 0G

T 53 09



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Pt Selection for Chemotherap!

(ssess age, functional status, comorbidities

!ombination chemotherapy preferred o'er single agents

8 ost pts are candidates for doublet chemo

8 onotherapy with 1*), capecitabine, taHanes in elderly,poor PS pts

Triplet:

8Figh functional status, younger pts without comorbidities

8 Willingness to tolerate (s

8 (ccess to freKuent follow*up and toHicity assessment



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Second6line;Salvage Therap!


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Second6line Therap! 3ecommendations


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G3:010G*010;.

5. )ord F, et al. Lancet Oncol. 530/>01:2;*;. Slide credit: clinicaloptions.com

SL!

S!

0.3

3.;

3.

3./

3.5

33 G 9 05 01 0;

#os

S u r v i v a l P r o b a b i l i t !

033

21

51

3

13

O S


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Targeted Therapies


32/63


Genome Atlas Pro-ect' Gene Amplification

in Esophagogastric Cancer

)B/ Esophageal;GastricCancers +B* C3Cs

(mplified genes in G26 ofgastroesophageal tumors

8 EGFR

8 HER2

8 MET

8 FGFR1-2

8 KRAS

Targetable receptors andreceptor tyrosine &inases


33/63

Gastric Adenocarcinoma' 1 Genomic

Subsets

+enomically unstable 41367

8 -ntestinal, present in most += tumors

8 Figh rate of p5 mutation, amplification of "T#s

S-*high 45567: Figh rate of microsatellite instability, genemutation, and promoter hypermethylation

+enomically stable 45367

8 (ssociated with diffuse histology, !H"-1 and RH#A mutation

Figh pstein*arr 'irus burden 4967

8 Figh rate of P$K!A mutation, P"-%1 and P"-%2 amplification,strong -L*05 signaling indicating an immune presence

The !ancer +enome (tlas "esearch $etwor&. $ature. 530/>10G:535*539. Slide credit: clinicaloptions.com


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Targeted Therapies

!on'entional, cytotoHic chemotherapy has limitedbenefit

Targeted agents: designed to bloc& specific tumorgrowth pathways

8 onoclonal antibodies

8 Tyrosine &inase inhibitors

"eceptor*associated tyrosine &inase mediatedpathways and downstream pathways



35/63

Phase III ToGA' Trastuumab 4 Chemo in

Advanced %E3)4 Gastric Cancer

"ationale: a subpopulation of gastric cancers o'ereHpress F"5

Primary endpoint: OSSelected at in'estigatorUs discretion: 1*) ;33 mgCm5Cday infusional on capecitabine 0333 mgCm5 -< on


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Events"

n

02

0;5

#os

59/

593

522

5

5/

55G

539

0;1

02G

0/G

0/2

002

00G

93

93

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/2

1

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/G

5/

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0

50

0/

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2

05

1

/

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3

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Pts at 3is" n

++&+ +0&J

3

3.0

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3./

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)! ? T

)!

%3

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B, CI

3.3*3.90

P @alue

.33/

#edianOS"

mos

0G.;

00.0

Phase III ToGA' OS

ang %=, et al. Lancet. 5303>G2:;2*92. Slide credit: clinicaloptions.com


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Events"

n

053

0G

#os

55;

50;

50;

09;

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023

023

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Pts at 3is" n

++&J +/&*

3

3.0

3.5

3.G

3./

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3.

3.2

3.;

3.9

0.3

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)! ? T

)!

%3

3.1

B, CI

3.10*3.;G

#edian

OS"

mos

0.3

00.;

ang %=, et al. Lancet. 5303>G2:;2*92.

Hploratory analysis


Phase III ToGA' OS in Pts With I%C 04 or

IS%4 and I%C )4


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Pts with F"5*amplified locally

ad'anced, unresectable, or

metastatic gastric, esophageal, or

+= cancer

4$ I 1/17

CapeOx? ? :apatinib 0513 mg <

50*day cycles

CapeOx? 4 Placebo

Fecht =, et al. = !lin Oncol. 5301>Apub ahead of printB.

Phase III :OGiC' CapeOx D :apatinib in

%E3)4 Advanced Gastric Cancer

Primary endpoint: OS

Secondary endpoints: P)S, O"",


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!apeOH ? L

!apeOH ? P

0.3

3.;

3.

3./

3.5

3.3

C u m u l a t i v e S u r v i v a l

P r o b

a b i l i t !

3 1 03 01 53 51 G3 G1 /3 /1

#os Since 3andomiation

CapeOx 4 :

)1B=

CapeOx 4 P

)0J=

#edian OS" #os


40/63

Phase III Clinical Trials of %E3)6$irected

Therap! in Gastric Cancer

)irst line

8 =(!O: capecitabineCcisplatinCtrastuMumab pertuMumab 4planned $ I 2;37A0B

8 FLO-S: capecitabineCcisplatin ? 5 dose le'els oftrastuMumab 4planned $ I /337A5B

Second line

8 +(TS%: paclitaHel 's T*


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@EG 3evisited7' Second and :ater :ine

of Therap!

(D(+(ST: capecitabineCcisplatin be'aciMumabA0B

8 $o OS benefit for addition of be'aciMumab in first*linesetting

(patinib 8 Small*molecule multitargeted T#- with acti'ity against

D+)"

8 Phase --- trial reported at (S!O 530/: median OSsignificantly longer with;13 mg < 's placebo 4091 's 0/3 days, respecti'ely>F": 3.207A5B

0. Ohtsu (, et al. = !lin Oncol. 5300>59:G9;*G92.

5. in S, et al. (S!O 530/. (bstract /33G. Slide credit: clinicaloptions.com


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Phase III 3EGA3$ Trial' KSC D 3amucirumab

in #et Gastric or GE. Cancer

Primary obVecti'e: OS

Secondary endpoints: P)S, 05*w& P)S, O"",


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KSC D 3amucirumab in #etastatic Gastric

or GE. Cancer G;G:G0*G9. Slide credit: clinicaloptions.com


44/63


or GE. Cancer P .33307

0.3

3.;

3.

3./

3.5

3

3 5 / 03 0/; 05 020 G 1 2 00 01 09 0G

#os

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002

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1

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3

3

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3

0

3

0

3

/

0

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5

0

2

/1

/

G3

5

0;

5

Pts at 3is" n

"amucirumab

Placebo

)uchs !S, et al. Lancet. 530/>G;G:G0*G9. Slide credit: clinicaloptions.com


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AE" 3amucirumab )0/= Placebo ++,=

An! Grade Grade 0 An! Grade Grade 0

FypertensionN 0 ; ; G

leedingChemorrhage 0G G 00 G

(rteriothromboembolic 5 0 3 3

Denous thromboembolic / 0 2 /

Proteinuria G 0 G 3

+- perforation 0 0 0 0

)istula 4+- and non*+-7 0 0 0 0

-nfusion*related reaction 0 3 5 3

!ardiac failure 0 3 3 3

-ncludes increased blood pressure.N$o grade / hypertension obser'ed among ramucirumab*treated pts.

)uchs !S, et al. Lancet. 530/>G;G:G0*G9.


or GE. Cancer


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,&)

0&J

,&)

0&/

3amucirumab vs KSC8+9

0,,=

$ocetaxel vs ASC8)9

+0+=

Chemo G;G:G0*G9.

5. )ord F, et al. (S!O +- 530G. (bstract L(/.

G. #ang =F, et al. = !lin Oncol. 5305>G3:010G*010;.

/. Thuss*Patience P!, et al. ur = !ancer. 5300>/2:5G3*5G0/.

0&J

1&*)&1

3 0 5 G / 1

(cti'e treatment S!C(S!

#edian OS b! Stud! Arm" #os

3andomied Second6line Gastric Cancer

Studies


47/63

Wil&e F, et al. Lancet Oncol. 530/>01:055/*05G1.

3AIHKOW' Second6line Paclitaxel D

3amucirumab in Advanced Gastric Cancer

"andomiMed, double*blind phase --- trial


Secondary endpoints: P)S, O"", TTP


Pts with metastatic or locally

ad' unresectable gastric or

+= cancer and progression

on first*line chemo

4$ I 17

3amucirumab ; mgC&g


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)nd6:ine 3amucirumab in Advanced

Gastric Cancer 01:055/*05G1.

5. )uchs !S, et al. Lancet. 530/>G;G:G0*G9.

3AIHKOW8+9 3EGA3$8)9



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3

3.0

3.5

3.G

3./

3.1

3.

3.2

3.;

3.9

0.3

3 5 03 0/ 0; 55#os

"am ? PacPlacebo ? Pac!ensored

P r o b a b i l i t ! o f P

S

3am;Pac Placebo;Pac 3amPtsCe'ents, n GG3C529 GG1C59 5G;C099edian, mos /./3 4/.5/*1.G57 5.; 45.29*G.357 5.0 40.1*5.274916 !-7*mo P)S, 6 G 0205*mo P)S, 6 55 03O"", 6 5; 0 P I .3330 G

P .33307

Second6line 3amucirumab in Adv Gastric

Cancer


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3AIHA::' Capecitabine;,6( 4 Cisplatin

D 3amucirumab in #etastatic Gastric CA

Slide credit: clinicaloptions.com!linicalTrials.go'. $!T35G0/002.

"andomiMed, double*blind, phase --- trial

Primary endpoint: P)S

Secondary endpoints: OS, P)S5, O"",

Pts with

metastatic

gastricC+= !(

with no prior first*line therapy

4$ I 0,

planned7

3amucirumab ; mgC&g -D


51/63

Investigational Therapies

Ph III T i l i G t i C


52/63

Phase III Trials in Gastric Cancer'

EG36Targeted Agents

"(LG: !J panitumumab 4#7A0B

8 $egati'e: panitumumab had inferior outcomes

JP($


53/63


c#ET Antibodies in Gastric Cancer'

Phase III Trials

Primary endpoint: OS in the et -F! 5?CG? pt subgroup

Locally ad'anced or metastatic

gastric and (+ !ancer, T*

positi'e by

immunohistochemistry 4-F!7

F"5 negati'e

Locally ad'anced or metastatic

gastric and (+ !ancer, T*

positi'e byimmunohistochemistry 4-F!7

F"5 negati'e

0. !linicalTrials.go'. $!T3092325. 5. !linicalTrials.go'. $!T305;9.

3I:O#ET6+8+9

#etGastric8)9


"

"

!J ?

"ilotumumab

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Targeting Amplified Gene Signaling

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Immune Checpoint Inhibitors


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Pembroliumab in Gastric Cancer Cohort


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Pembroliumab in Gastric Cancer Cohort


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Gastric Cancer' Tae %ome #essages

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Immune Checpoint Inhibitors in Adv&

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Go Online for #ore CCO

Coverage of Gastric Cancer

Expert revieLs of all the &ey data

Additional slidesets on gastric and other +- malignancies

clinicaloptions&com;oncolog!

cco gastric cancer ll slides

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