Agenus Reports Positive Phase 1b Data for Botensilimab and Balstilimab in Liver Cancer
Event summary
- Agenus published Phase 1b data for botensilimab (BOT) and balstilimab (BAL) in treatment-refractory hepatocellular carcinoma (HCC) patients who progressed after prior immunotherapy.
- The study reported an objective response rate (ORR) of 17%, including one complete response and two partial responses, with a median overall survival (mOS) of 12.3 months.
- The safety profile was consistent with prior reports, with no treatment-related deaths and manageable immune-mediated adverse events.
- The trial enrolled 19 patients between March 2021 and September 2023 across six U.S. sites.
- Agenus is advancing BOT+BAL in a global Phase 3 BATTMAN trial for refractory metastatic colorectal cancer.
The big picture
Agenus' Phase 1b data for BOT+BAL in HCC represents a strategic push into a challenging, post-immunotherapy patient population with limited treatment options. The results add to a growing body of evidence supporting the combination's activity across difficult-to-treat, late-line solid tumors. The company's focus on leveraging botensilimab's Fc-enhanced CTLA-4 design aims to address tumor immune evasion and expand the benefits of immunotherapy to refractory patients.
What we're watching
- Clinical Validation
- Whether the promising Phase 1b data for BOT+BAL in HCC will translate into successful outcomes in larger, more diverse patient populations.
- Regulatory Pathway
- The pace at which Agenus can advance BOT+BAL through subsequent clinical trials and potential regulatory approvals.
- Competitive Positioning
- How Agenus positions BOT+BAL against existing and emerging therapies for treatment-refractory HCC and other late-line solid tumors.
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