FDA Leaves Door Open For Further Discussions With Agenus Over BOT/BAL

 
• By Alaric DeArment

The biotech company surprised observers when it announced the agency advised against filing for accelerated approval of the CTLA-4/PD-1 combination.

• Source: Shutterstock

Agenus Inc. got an unwelcome surprise from the US Food and Drug Administration as the agency recommended against the company filing for accelerated approval for the combination of its CTLA-4-targeting monoclonal antibody botensilimab and the PD-1-targeting balstilimab (BOT/BAL) in relapsed/refractory microsatellite-stable colorectal cancer (MSS CRC) with no active liver metastases.

The biotech company said 18 July that it had an end-of-Phase-II meeting with the FDA in which it presented data from the Phase II study that was consistent with a Phase I study of the combination

Key Takeaways

  • Agenus said that in an end-of-Phase-II meeting, the FDA recommended against filing for accelerated approval of BOT/BAL in a type of colorectal cancer based on Phase II results.

  • The announcement came as a surprise for analysts, given that the combination had shown a clear ORR advantage over the control arm

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