RE:FDA guides on how AA can be converted to full approval.July 18, 2024 - The FDA turns down Agenus’ plans to seek accelerated approval for a colorectal cancer combination. Agenus is using a combination of its CTLA-4 blocking antibody botensilimab and PD-1 candidate balstilimab.
Agenus said the FDA discouraged a filing for accelerated approval because of its belief objective response rates may fail to translate into survival benefit.
No biomarker work appears to have been conducted or submitted.
In phase 1, Agenus saw a 23% response rate that translated into an estimated median overall survival of 21.2 months. The biotech made the estimate after a median of 13.6 months of follow-up. The median follow-up in the phase 2 cohorts ranges from 5.5 months to 9.5 months.
The phase 2 data are immature, though. And while Agenus plans to keep talking to the FDA as the data matures, the company faces the prospect of having to run a phase 3 study before it can seek approval.
https://www.fiercebiotech.com/biotech/fda-wrecks-agenus-accelerated-approval-plan-triggering-push-partner-cancer-combination