Bicara Phase 1b data: ficerafusp alfa 2000mg Q2W shows 48% ORR, 26% CR in 1L HPV-negative HNSCC

Bicara Therapeutics Inc.

48% confirmed ORR and 26% complete response rate in 27 patients with 1L HPV-negative R/M HNSCC.
77% of responders achieved deep responses (≥80% tumor shrinkage); median time to response 1.6 months.
Safety profile consistent with known profile of ficerafusp alfa plus pembrolizumab; generally well tolerated.
Company plans to develop loading and every-three-week maintenance regimen pending regulatory alignment.
Median PFS, DoR, and OS not yet estimable; data continue to mature.

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