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Posted On: 07/01/2025 12:16:58 AM
Post# of 154782
Quote:
I'm thinking, even if we doubled it to 14% and got it just above the diagonal line dividing the Cold Tumors from the Hot Tumors, then we should get Accelerated Approval on the surrogate biomarker of ORR.
Agenus' BOT/BAL has about 20% ORR from phase 1 and 2 data. (They also have a poster as ESMO.) A year ago, FDA discouraged them from applying for accelerated approval. In their Q1 earnings call from a month ago, they revealed FDA characterized their results as "modest overall response rates" and are not convinced the response rates reasonably predict a meaningful benefit for patients. FDA referenced a NEJM article by Julia Beaver and Richard Pazdur.
With new FDA leadership and more mature data, Agenus has requested a Type B meeting to again pursue accelerated approval. They take exception to the NEJM article.
Will be interesting to see how receptive the new FDA will be to Agenus. Vinay has in the past made the same critical comments on these surrogate endpoints.
Hopefully we get closer to your 30% ORR or even 40%.
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