Bicara Therapeutics released an abstract at the ESMO Asia 2025 Congress that reports early Phase 1b expansion‑cohort data for its lead candidate, ficerafusp alfa, in combination with pembrolizumab. The abstract, presented on December 1 2025, details the efficacy and safety of a 750 mg weekly dose in patients with first‑line, HPV‑negative recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
The 750 mg cohort achieved a 57 % overall response rate (ORR), with 50 % partial responses and 7 % complete responses, and an 83 % disease‑control rate. These results are consistent with the 1500 mg dose, which previously reported a 64 % ORR in the same patient population. Safety profiles for both doses were comparable, with no new safety signals identified. The consistency across dose levels supports the selection of 750 mg for the pivotal FORTIFI‑HN01 trial and suggests that a lower dose may provide similar efficacy with potentially reduced toxicity.
The data reinforce Bicara’s strategy to advance ficerafusp alfa through the regulatory pathway. The FDA’s Breakthrough Therapy Designation for the combination in first‑line HPV‑negative R/M HNSCC underscores the clinical promise of the dual EGFR/TGF‑β mechanism and positions the company for accelerated approval if pivotal trial results confirm the early signals. The Phase 1b findings also inform the design of the pivotal trial, including enrollment targets, dose‑escalation plans, and biomarker endpoints.
In the current treatment landscape, pembrolizumab alone is the standard of care for HPV‑negative R/M HNSCC, yet outcomes remain suboptimal. Ficerafusp alfa’s bifunctional design aims to overcome resistance by blocking EGFR signaling while neutralizing TGF‑β–mediated immunosuppression, potentially enhancing tumor penetration and immune activation. The early data suggest that this approach can achieve durable responses in a population with limited options, addressing a significant unmet need.
Analysts at H.C. Wainwright and Stifel have maintained buy ratings for Bicara, citing the consistent efficacy data and the Breakthrough Therapy Designation as key drivers of investor confidence. The company’s stock was trading at $18.56 on December 1, reflecting the market’s recognition of the milestone. The positive market reaction is largely attributed to the 57 % ORR at the 750 mg dose and the regulatory endorsement, both of which strengthen the company’s competitive positioning.
Management emphasized the significance of the findings. CEO Claire Mazumdar said the data “validate our platform and give us confidence in the pivotal trial’s design,” while Chief Medical Officer David Raben highlighted that the consistent ORR “reinforces our belief that a lower dose can achieve similar efficacy, which is critical for patient safety and trial feasibility.
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