Agenus Inc. (NASDAQ: AGEN) has published the results of its Phase 1b C‑800‑01 study of the botensilimab plus balstilimab (BOT+BAL) combination in women with platinum‑refractory ovarian cancer. The peer‑reviewed paper, appearing in the Journal for ImmunoTherapy of Cancer, reports a 23 % overall response rate (ORR) and a 31 % clinical benefit rate (CBR) in a cohort of 44 heavily pre‑treated patients.
The 23 % ORR represents a striking improvement over the 8‑10 % response rates historically seen with first‑generation checkpoint inhibitors in this setting, while the median overall survival of 14.8 months and 75 % 12‑month survival rate exceed the typical 6‑8 month survival observed in platinum‑refractory disease. These outcomes suggest that BOT+BAL can convert a historically refractory population into one that experiences durable benefit.
The trial enrolled 44 women who had progressed after platinum‑based therapy and at least one prior line of systemic treatment. Median duration of response was 9.7 months, and no new safety signals were identified, confirming the manageable safety profile that has been observed in earlier studies of the platform.
Steven O'Day, Chief Medical Officer, said the data “offer a meaningful signal of clinical activity for women with platinum‑refractory ovarian cancer, a group that has seen little therapeutic progress.” CEO comments echoed this confidence, noting that the results reinforce the platform’s potential and support plans to advance BOT+BAL into larger, randomized studies.
The publication strengthens the case for BOT+BAL beyond its established activity in colorectal cancer and opens the door to partnership and commercialization opportunities in ovarian cancer and other solid tumors. Agenus is positioning the combination for expanded clinical development, with the goal of demonstrating efficacy in phase 2 and phase 3 trials that could ultimately support regulatory approval and market access.
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