On December 22, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported the publication of results in the Journal of Clinical Oncology (JCO) from a global Phase 2 clinical study of balstilimab (Bal) plus zalifrelimab (Zal) in second-line (2L) recurrent/metastatic cervical cancer patients who had relapsed after treatment with platinum-based therapy (Press release, Agenus, DEC 22, 2021, View Source [SID1234597621]).
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"We’re excited to present this data from the largest study conducted to date, assessing the benefit from combined PD-1 and CTLA-4 inhibition in this patient population," said Steven O’Day, MD, Chief Medical Officer of Agenus. "The combination data with Bal (anti-PD-1) and Zal (anti-CTLA-4) in recurrent/metastatic cervical cancer represents a meaningful improvement over currently available therapies while demonstrating a well-tolerated safety profile. We are committed to pursuing the benefit of combination therapies with first-generation antibodies like Zal as well as with our next-generation candidates which include our Fc-enhanced anti-CTLA-4 antibody AGEN1181."
The trial showed that in the 125 evaluable patients treated with Bal/Zal, ORR was 25.6%; among PD-L1+ patients, the ORR was 32.8%. The Phase 2 trial was conducted in patients with recurrent/metastatic cervical cancer who had relapsed after prior platinum-based therapy, a population disproportionately represented by younger women, who have limited effective treatment options. Complete and partial responses were achieved by 8.0% and 17.6% of all patients respectively. The disease control rate in the trial was 52.0%. Responses achieved in patients were highly durable, with a median duration of response not yet reached (NR) following 21-month median follow-up (95% CI: 9.7 months to NR). Median overall survival was 12.8 months, with 69.2% and 53.3% of patients remaining alive at 6 and 12 months, respectively. Responses were observed across tumor histologies in the trial.
"With durable responses and a well-tolerated safety profile, the combined inhibition of PD-1 and CTLA-4 is a much-needed option for patients in this setting," said David O’Malley, MD, lead study investigator; Professor and Director of the Division of Gynecologic Oncology, The Ohio State University – James Cancer Center.
The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified. TRAEs leading to discontinuations occurred in 7.7% of patients.
About Cervical Cancer
Cervical cancer is a malignancy that originates in the cervix, the lower part of the uterus. It is the fourth most common cancer diagnosed among women globally, with nearly 14,500 patients expected to be diagnosed in the U.S. alone in 2021. Cervical cancer disproportionately affects younger women and is most frequently diagnosed between the ages of 35 to 44 in the U.S., with the average age at diagnosis being 50. Despite preventable measures such as HPV vaccination and early pap-smear that exist for prevention and early detection of disease, over 50% of cervical cancer cases in the U.S are only detected after the disease has spread. In patients whose disease has spread to distant parts of the body, 5-year survival rate in the U.S. is estimated to be 17%. Nearly 4,300 women are expected to die from cervical cancer in the U.S. in 2021.
About Balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.
About Zalifrelimab
Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 (IgG1) designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) from interacting with its ligands CD80 and CD86. CTLA-4 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.