Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors,  announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.

This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer – one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients.

“This recognition highlights the urgent unmet need for patients with HPV-negative R/M HNSCC,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “It also reinforces our conviction that depth and durability of response, driven by ficerafusp alfa's ability to synergize with pembrolizumab and enable tumor penetration, are key to achieving long-term clinical benefit.”

BTD was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa in combination with pembrolizumab in patients with 1L HPV-negative R/M HNSCC. Data most recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated deep and durable clinical benefit with a median duration of response of 21.7 months, and a median overall survival of 21.3 months, alongside a favorable safety and tolerability profile.

BTD is intended to expedite the development and review of potential new medicines that show substantial improvement over available therapies for serious or life-threatening conditions, providing greater interaction with the FDA, involvement of senior agency leadership, and eligibility for rolling and priority review.

“BTD provides external validation of the importance of ficerafusp alfa’s best-in-disease potential, and solidifies the foundation for our ongoing pivotal trial, FORTIFI-HN01,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. “We look forward to working closely with the FDA to bring this therapy to patients as quickly as possible.”