Agenus announces new data from its BOT/BAL at ESMO 2025

Agenus (AGEN) announced new data from its botensilimab, BOT, a multifunctional, Fc-enhanced CTLA-4 antibody and balstilimab, BAL, a PD-1 inhibitor, combination demonstrating durable survival across multiple cancer types in late-stage patients who have limited treatment options. The results, featured in an oral session at the European Society for Medical Oncology, ESMO, Congress 2025 in Berlin, Germany presented by Dr. Michael Gordon of HonorHealth Research Institute, include emerging two-year survival plateaus indicating a strong clinical signal that BOT/BAL’s benefit may be agnostic to tumor type. New data from expansion cohorts of 411 patients enrolled in the Phase 1b C-800-01 study evaluating BOT/BAL in patients with advanced, refractory disease across more than 5 cancer types. 61% of patients enrolled received three or more prior lines of therapy; Objective response rates: 17% across both BOT 1 mg/kg and 2 mg/kg doses; Signals of benefit across tumor types, including those historically unresponsive to immunotherapy, had prior treatment with checkpoint inhibitors, and/or with active liver metastases; 2-year median overall survival: 39%; Median OS: 17.2 months; Combination was well tolerated with most immune-related side effects were reversible and gastrointestinal in nature; no treatment-related deaths occurred ; Immune activation correlated with improved survival