Bicara selects 1500 mg ficerafusp alfa dose for Phase 3 pivotal HNSCC study

Bicara Therapeutics Inc.

Selected 1500 mg QW ficerafusp alfa plus pembrolizumab as optimal dose for Phase 3 FORTIFI-HN01 in 1L HPV-negative R/M HNSCC.
Expects substantial enrollment by end-2026 to enable interim analysis mid-2027 for potential accelerated filing.
Plans to present Phase 1b expansion data in 1L HNSCC (Q1 2026) and long-term follow-up (Q2 2026).
Will explore ficerafusp alfa in other solid tumors; Phase 1b mCRC data expected H2 2026.
Planning critical commercial hires in 2026, including Chief Commercial Officer, to prepare for launch.

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