Bicara Therapeutics Reports Positive Early Data for Ficerafusp Alfa Plus Pembrolizumab in Head and Neck Cancer Trial
Reuters
Dec 01, 2025
Bicara Therapeutics Reports Positive Early Data for Ficerafusp Alfa Plus Pembrolizumab in Head and Neck Cancer Trial
Bicara Therapeutics Inc. has announced the publication of an abstract with early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa administered weekly in combination with pembrolizumab in first-line, HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The results will be highlighted in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress. Preliminary data indicate that the overall response rate and safety profile at the 750mg dose are consistent with those observed at the 1500mg dose. These findings are being used to inform dose selection for the ongoing pivotal FORTIFI-HN01 clinical trial and have supported the FDA Breakthrough Therapy Designation for ficerafusp alfa in this setting. The company will discuss these results in a conference call and webcast scheduled for December 6, 2025.
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