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Agenus Announces End-of-Phase-2 Meeting Outcomes and Topline Interim Phase 2 Data for BOT/BAL in MSS Colorectal Cancer
Agreement reached with the FDA on Phase 3 dose for the BOT/BAL combination Accelerated approval pathway discouraged by FDA Preliminary Phase 2 data tracks
About this update from Agenus Inc.
[{"type":"text","content":"\n\nAgreement reached with the FDA on Phase 3 dose for the BOT/BAL combination\n\n\n\nAccelerated approval pathway discouraged by FDA\n\n\n\nPreliminary Phase 2 data tracks with Phase 1 BOT/BAL clinical activity in MSS mCRC (ORR ~19.4% and 90% alive at 6 months)\n\n\n\nStrategic meeting with the European agency scheduled for Q3 2024 to explore additional regulatory opportunities\n\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAgenus Inc. (NASDAQ: AGEN), a leader in developing novel immunological agents to treat various cancers, today announced the results of its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), for the advancement of its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).\n\n\nKey Outcomes of the EOP2 Meeting:\n\n\n\nDosing Regimen: Agenus gained agreement on the proposed BOT/BAL combination dosing regimen of 75mg BOT once every 6 weeks for up to 4 doses in combination with 240mg BAL once every 2 weeks for up to 2 years.\n\n\n\nRandomized Phase 2 Interim Data: Topline interim data suggest best activity seen at 75 mg BOT/240mg BAL combination (ORR 19.4%; 6-month survival rate of 90%; data continues to mature).\n\n\n\nAccelerated Approval: FDA advised against submission of these results in support of an Accelerated Approval based on their view that objective response rates may not translate to survival benefit.\n\n\n\nPhase 3 Protocol Design: The FDA recommended the inclusion of a BOT monotherapy arm at Agenus’ discretion in the Phase 3 study.\n\n\n\nDr. Steven O’Day, Agenus’ Chief Medical Officer, stated, “Based on the high level of enthusiasm from significant numbers of global clinical experts and the promising clinical activity we have seen in the Phase 1 and 2 studies, our commitment to seek all possible pathways to make BOT/BAL available to patients is unwavering. This includes exploring opportunities to partner in the U.S. to accomplish a successful Phase 3 trial.”\n\n\nAgenus previously disclosed data from the Phase 1 trial, which showed an overall response rate (ORR) of 23% in the 77 MSS mCRC patients without active liver metastases, with a median follow up of 13.6 months. The estimated 6-month, 12-month and 18-...