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Agenus Provides Update on Balstilimab Development
Company voluntarily withdraws BLA at FDA’s recommendation following full approval of pembrolizumab, which came four months earlier than FDA goal
About this update from Agenus Inc.
[{"type":"text","content":"Company voluntarily withdraws BLA at FDA’s recommendation following full approval of pembrolizumab, which came four months earlier than FDA goal dateBalstilimab achieved trial endpoints with 20% response rates in PD-L1 positive patients, versus 14% reported in pembrolizumab’s label; Agenus successfully completed 3 FDA pre-approval inspections for the PDUFA date of Dec. 16, 2021Agenus plans to launch expanded access programs to give patients access to balstilimab in several countries, including the USAgenus will discontinue its ongoing confirmatory trial (BRAVA) in this population, which is expected to reduce R&D expenses by over $100MAccelerated development of balstilimab in combination with AGEN1181 will be launched in multiple tumor types; clinical update at SITC LEXINGTON, Mass., Oct. 22, 2021 (GLOBE NEWSWIRE) -- Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor. The decision to withdraw the BLA does not change the development plans for balstilimab combinations. Following the full approval of pembrolizumab, announced four months earlier than the FDA goal date, the U.S. Food and Drug Administration (FDA) no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA, with a target action date of December 16, 2021. As part of the BLA review process, Agenus successfully completed 3 FDA inspections with no cited issues, concerns, or Form-483s. As previously reported, in the largest single-arm trial to date in this population (140 evaluable patients), balstilimab demonstrated objective responses in both PD-L1 positive and negative patients, with an objective response rate (ORR) of 20% and 8% respectively1. Pembrolizumab has demonstrated an ORR of 14% and 0% in PD-L1 positive and negative patients respectively, which led to its accelerated approval in 2018. Balstilimab has shown superior killing of PD-L1 negative tumors compared to other anti PD-1 therapies, including pembrolizumab, suggesting a broader mecha...