Bicara Therapeutics (BCAX) Study update summary

Study overview and design

• Phase 1/1b expansion cohorts evaluated Ficera (ficerafusp alfa) plus pembrolizumab in first-line recurrent/metastatic HPV-negative head and neck squamous cell carcinoma (HNSCC), enrolling approximately 90 patients across three dose cohorts (750 mg QW, 1,500 mg QW, 2,000 mg Q2W) with up to three years of follow-up.

• The pivotal phase III FORTIFY-HN01 trial is ongoing, with design validated by these results.

• Patient demographics included those with large, bulky tumors, low CPS, and ECOG PS 0-1, reflecting real-world HPV-negative HNSCC populations.

• Baseline characteristics were balanced across cohorts, with most patients male and primary tumors in the oral cavity or oropharynx.

• Data snapshot as of March 31, 2026, with median follow-up up to 36 months in some cohorts.

Efficacy and clinical outcomes

• At 1,500 mg QW, estimated three-year overall survival was 31%, nearly double that of standard of care in HPV-negative patients.

• Confirmed objective response rates ranged from 48% to 57% across cohorts, with complete response rates up to 30% in the highest cohort.

• Deep responses (≥80% tumor shrinkage) were achieved by 64–80% of responders at higher doses, correlating with improved long-term outcomes.

• Median duration of response reached 21.7 months at the pivotal dose, with deep responders experiencing a median DOR of 31.6 months and median PFS of 36.9 months.

• Median progression-free survival improved to 6.9–12.7 months across cohorts, exceeding standard of care.

Safety and tolerability

• Ficera plus pembrolizumab was generally well-tolerated with no new safety signals observed up to three years across all dose cohorts.

• Most common treatment-related adverse events included dermatitis acneiform, pruritus, anemia, and fatigue, with grade 3 or higher events infrequent.

• TGF-beta related adverse events such as mucosal bleeds and anemia were mostly low grade and manageable, with low discontinuation rates (6–10%).

• No treatment-related deaths were reported, and safety profile remained consistent across dose levels.

• Proactive management of baseline anemia was implemented to mitigate TGF-beta trap toxicities.