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Agenus

Agenus Reports 48% Estimated Three-Year Survival With BOT+BAL in Recurrent Ovarian Cancer at IGCS 2026

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Agenus reported an estimated 48% overall survival at three years among 35 efficacy-evaluable patients treated with investigational botensilimab plus balstilimab (BOT+BAL) for recurrent ovarian cancer. The company also reported 48% estimated survival at two years. These are outcomes from a small, uncontrolled Phase 1b cohort—not evidence that the combination caused the survival observed or an established treatment option.

What Agenus reported

The results were presented October 3, 2026, at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting in Montréal. Agenus said the analysis used data cut off on December 13, 2025. The poster, number 969, was titled “Next Generation Immune Checkpoint Inhibition with Botensilimab Plus Balstilimab in Recurrent Ovarian Cancer: Results by Platinum Sensitivity Status and 3-Year Overall Survival.” Rebecca L. Porter, MD, of Dana-Farber Cancer Institute, presented it.

In the 35-patient efficacy group, Agenus reported estimated overall survival of 48% at both two and three years, with median overall survival of 14.8 months. The announcement does not provide a comparator for this ovarian cohort. The estimates describe what happened in the reported group; they do not establish that BOT+BAL improved survival relative to another treatment or no treatment.

Who was in the study

The results came from the recurrent ovarian cancer cohort of C-800-01 (NCT03860272), a multicenter Phase 1b study evaluating botensilimab with or without balstilimab in advanced solid tumors. Patients in the ovarian cohort had recurrent disease and either had no standard therapy available or had experienced progression after standard treatment.

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Agenus reported a median of four prior lines of therapy. All patients had received platinum chemotherapy; 77% had previously received bevacizumab and 57% a PARP inhibitor. Nearly three-quarters had platinum-resistant or platinum-refractory disease.

The denominators matter: the efficacy analysis included 35 patients who had at least one tumor scan after starting therapy. The safety population comprised all 44 patients who received at least one dose. At last follow-up, 11 of those 44 patients (25%) were alive and off all therapy.

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Other reported measures of tumor activity

Agenus reported an objective response rate of 23% (8 of 35): one complete response and seven partial responses. Median duration of response was 9.7 months. Eleven of 35 patients (31%) had a response or stable disease lasting at least 24 weeks. These measures describe tumor response or disease control; they are not interchangeable with overall survival.

Subgroup results, read cautiously

Agenus also reported results for groups defined by platinum sensitivity and prior treatment. These are small, descriptive subsets within the same cohort, not comparisons that establish which patients benefit more.

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Group Patients Estimated three-year overall survival Reported response
Platinum-resistant or refractory 25 47% 20% (5/25): 1 complete and 4 partial responses
Platinum-sensitive 10 45% 30% (3/10), all partial responses
At least four prior lines of therapy 23 48% 17% (4/23), all partial responses
Disease progressed on a PARP inhibitor 17 61% 12% (2 partial responses)

The groups reflect different patient characteristics and may overlap. Their sizes are small, and the announcement supplies no controlled comparison; the figures should not be used to rank subgroups or predict an individual patient’s outcome.

What the 48% estimate does—and does not—show

Overall survival is the proportion of patients estimated to be alive at a given time point. A reported three-year estimate of 48% in this cohort is not the same as saying treatment extended each patient’s life by three years. Median overall survival of 14.8 months is a separate statistic: it marks the point at which the estimated survival curve reaches 50%, and can coexist with a longer-term estimate below 50%.

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The Phase 1b cohort was small and the company announcement reports no control group for these ovarian-cancer results. Without a comparator, the observed outcomes cannot show what would have happened to similar patients under another therapy or establish a causal treatment effect. Agenus’s announcement is a syndicated company release describing the presentation; it is not an independent validation of the full poster methods or analysis.

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What BOT+BAL is and its availability

Agenus describes botensilimab (BOT) as a multifunctional, Fc-enhanced anti-CTLA-4 antibody and balstilimab (BAL) as an anti-PD-1 antibody. Both remain investigational and are not approved by the U.S. Food and Drug Administration. Agenus says access is through clinical trials and certain authorized early-access mechanisms, subject to local rules. Its announcement describes a hospital-based AAC arrangement with reimbursement under defined criteria for eligible patients in France and possible paid named-patient access in select other countries; those company-described pathways are jurisdiction-specific and do not guarantee access.

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Agenus said safety was consistent with the known BOT+BAL profile, with no new safety signals or treatment-related deaths reported in this ovarian cohort. This is the company’s characterization of the cohort, not an independent safety assessment.

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