Cervical Cancer Awareness Month A 24/7 Job at Agenus

Vol. 3 Issue 02 · Jan 21, 2020

Current Statistics on Cervical Cancer Currently, cervical cancer is the 4th most common cancer among women globally and a leading cause of death. In 2018, 570,000 women were diagnosed with cervical cancer globally1. The American Cancer Society predicts that 13,800 women will be diagnosed with cervical cancer in the US during 20202. About 4,290 will die of the disease. Currently, there are no effective therapies for patients with recurrent, metastatic cervical cancer. The best available treatment in recurrent cervical cancer has achieved response rates of only 14%3. Even then, a patient’s disease progresses rapidly after about 2 months. 

While cervical cancer incidence would be expected to decline given prevention efforts such as HPV vaccination and screening with regular Pap smears, there remains an alarmingly high number of new cases globally. Please visit the American Cancer Society website for more information on prevention.

Forward-Looking Statements: This Agenus Newsletter includes forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding clinical and regulatory plans and timelines, and the anticipated benefit of balstilimab and zalifrelimab over currently available treatments for cervical cancer. These statements are subject to risks and uncertainties, including those described in our SEC filings.

Agenus’ Balstilimab/Zalifrelimab Combination Therapy: The Goal of Higher Response Rates and More Durable Benefit for 2L Cervical Cancer PatientsDuring our R&D Day in November, Dr. Bradley Monk highlighted the advantages Agenus’ combination may offer to advanced cervical cancer patients. Dr. Monk pointed to recent data that was presented at the 2019 ESMO Annual Meeting, showing that addition of CTLA-4 to PD-1 therapy resulted in response rates that were meaningfully higher than PD-1 monotherapy alone in cervical cancer6. In fact, the benefit of adding CTLA-4 to PD-1 therapy has now been demonstrated in multiple tumor types. In particular, CTLA-4 + PD-1 combinations significantly enhance longevity of responses in several malignancies, including other deadly cancers such as melanoma and NSCLC.

Agenus is committed to rapidly advance its current generation I-O antibodies to BLA filings - balstilimab (PD-1) monotherapy as well as our balstilimab combination with zalifrelimab (our CTLA-4). In addition, we are also committed to advance our NextGen I-O antibodies including AGEN 1181 for the effective treatment of cervical cancer. We are one of the very few companies to have antibodies targeting both PD-1 and CTLA-4 in our pipeline. At our recent R&D Day, Agenus’ Dr. Anna Wijatyk presented data from patients who responded to and were continuing balstilimab/ zalifrelimab combination therapy:

Current Treatment OptionsDespite increases in cervical cancer screening, a large proportion of women are diagnosed with advanced-stage or metastatic cervical cancer. In contrast with other gynecological cancers, few treatment options exist for patients at this stage. Historically, chemotherapy, radiation and surgery have been the only treatment options. Only three medicines have been approved by the FDA for advanced cervical cancer over the last decade: topotecan, a chemotherapy agent which is not widely used due to toxicity; bevacizumab, a targeted therapy, and most recently pembrolizumab, an anti-PD-1 immunotherapy which has achieved only a 14% response rate3. The other two therapies demosntrated even lower response rates4,5.

Agenus’s pipeline of immunotherapy agents includes both single-agent and combination antibody treatments for patients with recurrent, metastatic cervical cancer. We are planning to file two BLAs with our balstilimab  (PD-1) monotherapy as well as balstilimab combination with zalifrelimab (our CTLA-4 therapy). Agenus’ balstilimab/ zalifrelimab combination has the potential to achieve higher response rates than any currently available cervical cancer therapy.

CERVICAL CANCERAWARENESS MONTH

References:

1. World Health Organization. Cervical Cancer. Available at: https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/

2. American Cancer Society. Key Statistics for Cervical Cancer. Available at: https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html

3. Chung, HC, et al. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results from the Phase II KEYNOTE-158 Study. J. Clinical Oncology. Available at: https://ascopubs.org/doi/full/10.1200/JCO.18.01265

4. Monk, B, et al. Phase II Trial of Bevacizumab in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study. J Clin Oncol. 2009 Mar 1; 27(7): 1069–1074.

5. Bookman, MA, et al. Topotecan in squamous cell carcinoma of the cervix: A Phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2000 Jun;77(3):446-9.

6. Naumann RW, Oaknin A, Meyer T, et al. Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358. Presented at 2019 ESMO Congress; September 27-October 2, 2019; Barcelona, Spain. Abstract LBA62.

Agenus Joins the Cervical Cancer Awareness CommunityOn January 31st, as part of Cervical Cancer Awareness Month, Agenus will be hosting a healthy eating teach-in for cervical cancer patients and survivors in the Greater Boston area with Chef German Lam. Chef Lam is a cancer survivor and author of The Dragon Turns to Water: Chef Lam Fights Cancer with a Freestyle Lifestyle.