- Agenus Inc. (AGEN, Financial) presents promising data for BOT/BAL in pretreated liver cancer at AACR 2025.
- The combination therapy shows a 72% disease control rate in advanced HCC patients.
- Continued evaluation could establish BOT/BAL as a novel treatment approach for difficult cancers.
Agenus Inc. (AGEN), a clinical-stage immuno-oncology company, has shared noteworthy results from its Phase 1 study of botensilimab (BOT) combined with balstilimab (BAL) for hepatocellular carcinoma (HCC). The data was unveiled at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, highlighting durable responses in patients with advanced HCC who had previously not responded to approved immunotherapies.
The study evaluated 19 patients with metastatic and treatment-refractory HCC, with 18 patients assessable for efficacy. These patients received a median of two prior treatments and had progressed following anti-PD(L)-1 therapy. The clinical findings demonstrated a disease control rate of 72%, including a 17% overall response rate and a 56% stable disease rate. Median progression-free survival was noted at 4.4 months, while median overall survival was 12.3 months. The safety profile of the BOT/BAL combination remained manageable and consistent with previous studies.
Dr. Anthony El-Khoueiry from the USC Norris Comprehensive Cancer Center emphasized the unmet need in treating advanced HCC, expressing optimism about the potential of this combination therapy. Agenus' Chief Medical Officer, Dr. Steven O’Day, also noted that consistent responses across various challenging tumor types underscore the clinical utility of BOT and BAL.
This presentation aligns with Agenus' mission to expand cancer immunotherapy benefits through innovative combinations. The detailed results offer encouragement for ongoing and future trials aimed at hard-to-treat cancers.