Bicara Therapeutics (BCAX) Study update summary

Study design and objectives

• Ficerafusp alfa (FICERA), a bifunctional EGFR/TGF-β antibody, is being evaluated in the pivotal FORTIFI-HN01 trial for first-line recurrent/metastatic HPV-negative head and neck squamous cell carcinoma (HNSCC), using a seamless Phase 2/3 design for accelerated dose selection and efficient Phase 3 initiation.

• The study includes phase II dose optimization and phase III pivotal portions, with patients randomized to 1,500 mg weekly plus pembrolizumab or standard of care, and a parallel exploratory cohort testing 2,000 mg every two weeks with pembrolizumab.

• Additional cohorts and a phase 1b expansion evaluated less frequent dosing strategies (2,000 mg Q2W) to support commercialization and patient convenience.

• Plans are underway to explore a loading phase followed by every-three-week maintenance dosing to enhance patient convenience.

Patient characteristics and dosing

• The 2,000 mg Q2W ficerafusp alfa plus pembrolizumab cohort included 30 patients, median age 63, with 67% male and 33% female, most with oral cavity or oropharynx as the primary site and all with CPS ≥1.

• ECOG performance status was 0 or 1 for all participants.

Key efficacy and safety findings

• Ficerafusp alfa plus pembrolizumab at 2,000 mg Q2W showed a 48% confirmed response rate, 26% complete response rate, and 85% disease control rate, with 77% of responders achieving ≥80% tumor shrinkage.

• Median time to response was 1.6 months, with deep and durable responses observed and 100% of responders maintaining deep responses at 24 weeks.

• Durability of response is notable, with several patients maintaining response beyond 20 months.

• Safety profile was generally well-tolerated and consistent across dosing regimens, with low discontinuation rates, no new safety signals at higher doses, and most common adverse events including dry skin, anemia, fatigue, epistaxis, stomatitis, pruritus, headache, and nausea.

• Grade 3 anemia was slightly higher at the 2,000 mg dose but manageable with standard supportive care.