Agenus Presents Results from Two Large Cervical Cancer Trials at ESMO

• 160 patient balstilimab (PD-1) monotherapy trial achieves response rates of 14% in all treated patients and 19% in PD-L1 positive patients
• 155 patient balstilimab (PD-1) + zalifrelimab (CTLA-4) combination trial achieves response rates of 22% in all patients and 27% in PD-L1 positive patients

LEXINGTON, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today presented preliminary results from two large clinical trials of more than 150 patients each at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Both trials were conducted in patients with recurrent/metastatic cervical cancer which has limited effective treatment options and disproportionately affects younger women.

“Balstilimab has shown activity in both PD-L1 positive and negative tumors, suggesting that we may have a potentially differentiated PD-1,” said Dr. Garo Armen, Chairman and CEO of Agenus. “Furthermore, we have also shown important expansion in response rates, to near doubling in PD-L1 positive patients, and durability of response when patients receive zalifrelimab in combination with balstilimab.”

The presentation was made by Dr. David O’Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). Dr. O’Malley is the lead investigator of the trials presented.

“These trials represent the largest trials of immuno-oncology therapies in relapsed cervical cancer to date and show that balstilimab and zalifrelimab may present meaningful new therapies for patients with cervical cancer,” said Dr. O’Malley. “Advances in these agents offer renewed hope for patients who have limited treatment options.”

Summary of Data Presented at ESMO2020

	AGEN PD-1 Balstilimab n=160*		AGEN PD-1 + CTLA-4 Balstilimab + Zalifrelimab n=143*
Response rates (ORR) PD-L1(+) PD-L1(-)	14% 19% 10%		22% 27% 11%
ORR by tumor histology Squamous cell carcinoma