Bicara Therapeutics Data From Phase 1b Expansion Cohort Of 2000mg Of Ficerafusp Alfa Every Other Week In Combination With Pembrolizumab Shows Q2W Generally Well-Tolerated, Safety Profile Consistent; Demonstrated 48% Overall Response Rate

Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today presented preliminary safety and efficacy data from an exploratory Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every other week (Q2W) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The expansion cohort data, which explore a higher dose and less-frequent dosing regimen of ficerafusp alfa, are being highlighted in a plenary presentation today at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS).

Ficerafusp alfa is the first and only bifunctional epidermal growth factor receptor (EGFR)-directed antibody combined with a TGF-β ligand trap designed to drive increased tumor penetration and improve survival outcomes. Bicara is currently evaluating ficerafusp alfa at 1500mg weekly (QW) in Phase 3 of the ongoing FORTIFI-HN01 pivotal study.

The Phase 1b expansion cohort data presented at MHNCS show that 2000mg Q2W ficerafusp alfa in combination with pembrolizumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC. 2000mg Q2W of ficerafusp alfa demonstrated a 48% confirmed overall response rate (ORR), with 26% of patients achieving a complete response (CR) and 77% of responders demonstrating deep responses of at least 80% tumor shrinkage. Preliminary efficacy data demonstrated enhanced durability and additional outcomes data continue to mature.