1L recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
BCAXBicara TherapeuticsCatalyst overview
Research summary
This catalyst tracks a Phase 2/3 data readout for Ficerafusp alfa + Pembrolizumab in 1L recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) . The expected timing is based on the latest available company guidance and may change.
FORTIFI-HN01 trial. 2/25- Dosed 1st participant. 12/06/25:- Optimal dose declaration expected in Q1 2026. 01/12/26:- 1500mg QW combo chosen as Ph3 FORTIFI-HN01 dose; interim analysis planned Mid-2027 after 2026 enrollment. 03/30/26:- Phase 3 FORTIFI-HN01 initiated; substantial enrollment targeted by end 2026, enabling mid-2027 ORR interim analysis. 05/11/26:- FORTIFI-HN01 on track for mid-2027 ORR interim; randomized loading/maintenance regimen study planned to start in Q3 2026. 05/21/26:- FORTIFI-HN01 Ph2/3 continues; alternate loading/maintenance dosing study planned Q3 2026; ASCO poster May 30. 08/11/26:- FORTIFI-FLEX alternate-dosing study was initiated. FORTIFI-HN01 substantial enrollment is expected by year-end 2026; topline interim results will follow in Mid-2027.
Verification
Confirm timing and program details against the company announcement or filing.