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Agenus reported an estimated three-year overall survival of 48% among 35 efficacy-evaluable patients in its recurrent ovarian cancer cohort of the Phase 1b C-800-01 study. The company presented the results at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting on October 3, 2026. The finding is an outcome observed in a small, uncontrolled cohort—not proof that botensilimab plus balstilimab caused patients to live longer.
What the 48% three-year survival estimate means
In the C-800-01 recurrent ovarian cancer cohort, Agenus reported estimated overall survival of 48% at three years and 48% at two years. Median overall survival was 14.8 months. These are separate ways of describing the cohort’s survival: the percentage is an estimated proportion alive at specified time points, while the median is the point by which half the patients had died.
The efficacy analysis covered 35 patients who had at least one tumor scan after starting treatment. It should not be confused with the safety population: 44 patients received at least one dose. At the data cutoff of December 13, 2025, Agenus reported that 11 of those 44 patients (25%) were alive and off all therapy.
The results were presented in poster 969, “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 the data at the meeting in Montréal, Canada.
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Who took part in the ovarian cancer cohort
C-800-01 (NCT03860272) is a multicenter Phase 1b study evaluating botensilimab (BOT), with or without balstilimab (BAL), in advanced solid tumors. The recurrent ovarian cancer cohort enrolled patients whose disease had progressed after standard treatment or for whom no standard therapy was available.
Participants had received substantial prior treatment. Agenus reported a median of four previous lines of therapy; all had received platinum chemotherapy, 77% had received bevacizumab, and 57% had received a PARP inhibitor. Nearly three-quarters had platinum-resistant or platinum-refractory disease.
Other outcomes reported by Agenus
The company reported an objective response rate of 23% (8 of 35 patients): one complete response and seven partial responses. Median duration of response was 9.7 months. A further measure combined response and stable disease: 11 of 35 patients (31%) had a response or stable disease lasting at least 24 weeks.
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1Scan for outdated or missing drivers - takes under a minute2Clear out junk files and repair common Windows errors3Fix the driver behind crashes, sound loss and screen glitchesAgenus said safety in the ovarian cohort was consistent with the known BOT+BAL profile, with no new safety signals or treatment-related deaths reported. This is the company’s characterization of the cohort, not an independent safety assessment.
Results by platinum status and treatment history
Agenus also described outcomes in small patient subgroups. They are within-cohort estimates, not evidence that the treatment worked better in one subgroup than another.
| Group | Patients | Estimated three-year overall survival | Reported response |
|---|---|---|---|
| Platinum-resistant or refractory | 25 | 47% | 20% (5/25): one complete and four partial responses |
| Platinum-sensitive | 10 | 45% | 3/10 (30%), 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% | Two partial responses (12%) |
The subgroups are small, and the announcement does not provide a comparator for the ovarian cohort. The figures therefore describe what Agenus observed in these groups; they do not establish meaningful differences between patient types or a treatment effect.
Why the result does not establish that BOT+BAL extends survival
A 48% estimated survival at three years may be notable in this heavily pretreated cohort, but the number alone cannot show what would have happened to the same patients without BOT+BAL. The report is from a Phase 1b cohort and does not include a controlled comparison for these ovarian cancer results. Patient selection, the small sample, and the analysis method can all affect an estimate from a cohort of this size.
Porter said in Agenus’s announcement that conventional checkpoint immunotherapy has rarely produced lasting benefit in recurrent ovarian cancer, particularly after disease stops responding to platinum chemotherapy. Agenus Chief Medical Officer Steven J. O’Day said the survival curve extended beyond two years among women who had already received multiple treatments, including patients with resistant or refractory disease. These are attributed comments in the company release, not independent validation of the results.
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BOT+BAL remains investigational
Agenus describes botensilimab as a multifunctional, Fc-enhanced anti-CTLA-4 antibody and balstilimab as an anti-PD-1 antibody. Both are investigational and are not approved by the U.S. Food and Drug Administration. The reported data do not make the combination an established treatment option.
The company says access is through clinical trials and certain authorized early-access mechanisms where local rules permit. Its announcement says eligible patients in France may receive the combination through a hospital-based AAC arrangement with reimbursement under defined criteria; it also describes paid named-patient programs in select other countries. These are jurisdiction-specific routes, not a general guarantee of availability.
Source and scope
The results and study details above were reported by Agenus in its announcement of the October 3, 2026 presentation. The announcement is a syndicated issuer release; it is not the full poster or an independent peer-reviewed publication.
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