Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in HPV-Negative Head and Neck Cancer
📅 October 14, 2025 | Boston, MA
Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company developing bifunctional antibody therapies for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its lead candidate ficerafusp alfa, in combination with pembrolizumab, for the first-line (1L) treatment of patients with HPV-negative recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS ≥1).
A Distinct Subtype with Unmet Need
HPV-negative HNSCC is increasingly recognized as a distinct and more aggressive clinical entity within head and neck cancer, often associated with poor outcomes and limited treatment options. Approximately 80% of R/M HNSCC cases are HPV-negative, and these patients frequently experience severe local recurrence, pain, and reduced quality of life.
“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 reinforces our conviction that ficerafusp alfa’s synergistic mechanism with pembrolizumab can drive durable and deep responses.”
Clinical Evidence Supporting Breakthrough Designation
The BTD is supported by results from multiple Phase 1/1b cohorts, evaluating ficerafusp alfa in combination with pembrolizumab.
At the 2025 ASCO Annual Meeting, data demonstrated:
- Median Duration of Response: 21.7 months
- Median Overall Survival: 21.3 months
- Favorable safety and tolerability profile
These findings indicate deep, durable clinical benefit and strong potential for long-term disease control.
Accelerated Development Pathway
Breakthrough Therapy Designation enables enhanced FDA collaboration and expedited review for therapies showing substantial improvement over existing treatments. It provides opportunities for:
- Frequent FDA guidance
- Rolling submission of data
- Priority review eligibility
“This designation validates ficerafusp alfa’s best-in-disease potential,” said Claire Mazumdar, PhD, MBA, CEO of Bicara Therapeutics. “It strengthens our foundation as we advance the pivotal FORTIFI-HN01 trial.”
About the FORTIFI-HN01 Trial
FORTIFI-HN01 is a global, double-blind, placebo-controlled Phase 2/3 study enrolling ~650 patients with HPV-negative R/M HNSCC and PD-L1 CPS ≥1.
- Primary Endpoints: Overall response rate and overall survival
- Secondary Endpoints: Progression-free survival and duration of response
Results from this study could support both accelerated and full regulatory approval.
About Ficerafusp Alfa
Ficerafusp alfa is a first-in-class bifunctional antibody that combines:
- EGFR-targeting monoclonal antibody domain, and
- TGF-β–binding domain
This design aims to reverse the fibrotic, immune-excluded tumor microenvironment, enhancing tumor penetration and synergy with checkpoint inhibitors like pembrolizumab.
About Bicara Therapeutics
Bicara Therapeutics is advancing bifunctional antibody therapies to overcome the challenges of solid tumor treatment. Its lead program, ficerafusp alfa, is being evaluated in head and neck squamous cell carcinoma and other solid tumors with significant unmet needs.
🔗 Learn more at Bicara Therapeutics
Source: Bicara Therapeutics Press Release (Oct 13, 2025)
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