Agenus Confirms Agreement With FDA On Design Of Global BATTMAN Phase 3 Trial

Agenus also confirmed that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of the global BATTMAN Phase 3 trial. The FDA waived the need for a BOT monotherapy arm, allowing for a simple two-arm study design. These new BOT/BAL data were reported at the 2025 ESMO Gastrointestinal Cancers Congress (ESMO-GI) in Barcelona, Spain, along with regulatory updates from its July 1, 2025 End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA).

FDA Meeting Outcomes

Official minutes from the July 1, 2025 End-of-Phase 2 (EoP2) meeting reflect a meaningful shift in FDA alignment since July 2024, establishing two new areas of agreement:

1. Contribution of components – FDA wrote that the current data "appears to support" balstilimab's contribution to the combination's clinical activity and therefore a registrational Phase 3 trial may proceed without a BOT monotherapy arm.
2. Phase 3 registrational trial –BATTMAN (CCTG CO.33): FDA and Agenus aligned on the core design of this global registration study for BOT/BAL. Agenus is incorporating the Agency's feedback and will initiate BATTMAN in Q4 2025.