Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced new clinical data from pre-planned interim analyses of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) and data from a dose escalation study of AGEN1181, a novel multi-functional enhanced CTLA-4 antibody.
The interim analysis from 34 evaluable patients treated with the combination of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) demonstrated a 20.6% overall response rate (ORR), which included a complete response (CR) rate of 8.8% in second-line cervical cancer. The interim analysis from 44 evaluable patients treated with balstilimab monotherapy demonstrated an ORR of 11.4% in second-line cervical cancer. The clinical activity observed in both studies are comparable to other agents in these therapeutic classes. Both balstilimab monotherapy and the combination of balstilimab and zalifrelimab were well-tolerated with no new safety signals.
Additionally, early clinical data from a dose-escalation study of AGEN1181 revealed a confirmed CR in a patient with a difficult-to-treat, PD-L1 negative, microsatellite stable, endometrial cancer. The patient was treated with a low dose of AGEN1181 (1 mg/kg) and had failed prior treatment with a PD-1 inhibitor. Additionally, stable disease was noted in the majority of patients treated. AGEN1181 monotherapy was well-tolerated. Balstilimab, zalifrelimab and AGEN1181 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.
Presenters will include global experts in immune-oncology, Dr. Chuck Drake, Co-Director, Cancer Immunotherapy Program, Columbia University Herbert Irving Comprehensive Cancer Center, and Dr. Bradley Monk, M.D., FACS, FACOG, CoDirector of GOG Partners, Arizona Oncology (US Oncology Network) and Professor, Gynecologic Oncology at University of Arizona, and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona. 2020 Global Data Point.