• Bicara outlined development strategy for ficerafusp alfa (FICERA), an EGFR-directed antibody bound to a TGF-β ligand trap, targeting first-line recurrent or metastatic HPV-negative head and neck squamous cell carcinoma.
• Phase 1b data for FICERA 1500 mg once weekly with pembrolizumab in HPV-negative, CPS≥1 patients showed confirmed ORR 54% (15/28) with CR rate 21% (6/28); median duration of response 21.7 months.
• Overall survival in that cohort was median 21.3 months with 2-year OS rate 46% at median follow-up 25.2 months.
• Company highlighted a manageable safety profile for the 1500 mg regimen with no treatment-related deaths, with EGFR-related adverse events common.
• Pivotal study is underway with interim analysis targeted for mid-2027; additional signal-seeking work planned in other solid tumors starting with metastatic colorectal cancer.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bicara Therapeutics Inc. published the original content used to generate this news brief on May 11, 2026, and is solely responsible for the information contained therein.