Bicara Therapeutics presented data from a Phase 1b expansion cohort of its lead candidate ficerafusp alfa at a 2000 mg every‑other‑week dose in combination with pembrolizumab at the Multidisciplinary Head and Neck Cancers Symposium. The cohort, comprising first‑line human papillomavirus‑negative recurrent/metastatic head and neck squamous cell carcinoma patients, reported a 48 % confirmed overall response rate, 26 % complete responses, and 77 % of responders achieving deep responses of at least 80 % tumor shrinkage.
Compared with the 1500 mg weekly cohort that achieved a 54 % overall response rate and 18 % complete responses, the 2000 mg Q2W schedule delivers a slightly lower overall response but a markedly higher complete response rate and a deep response rate that exceeds 75 %. The higher complete response rate suggests that the less frequent dosing does not compromise efficacy and may even enhance tumor eradication, a finding that could shift the therapeutic window for patients who require fewer clinic visits.
Safety data for the 2000 mg Q2W cohort were consistent with earlier ficerafusp alfa studies, with no new safety signals identified. The most common adverse events were infusion‑related reactions and fatigue, occurring at rates comparable to the 1500 mg weekly cohort. Early durability signals are encouraging, as several time‑to‑event endpoints remain not estimable due to immature follow‑up, but the depth of response and sustained tumor shrinkage observed to date suggest durable benefit.
Biomarker and pharmacokinetic analyses demonstrated that the 2000 mg Q2W regimen maintains robust TGF‑β neutralization and immune activation, mirroring the pharmacodynamic profile of the 1500 mg weekly schedule. Tumor biopsies showed sustained TGF‑β ligand trap activity and increased CD8+ T‑cell infiltration, supporting the mechanistic rationale for the alternative dosing strategy.
Bicara is advancing a loading and every‑three‑week maintenance strategy that would begin with a 2000 mg Q2W loading phase followed by 2000 mg every three weeks. The company believes this schedule could improve patient convenience and adherence while preserving the deep responses seen in the expansion cohort. The pivotal FORTIFI‑HN01 trial continues to enroll patients on the 1500 mg weekly regimen, and the company is engaging regulators to align on the alternative dosing pathway.
Chief Medical Officer David Raben said, “Results from this alternative dosing cohort, including rapid, deep and durable responses, a consistent safety profile, and sustained TGF‑β neutralization in 1L HPV‑negative R/M HNSCC patients, reinforce the strength of ficerafusp alfa’s differentiated mechanism of action.” Chief Executive Officer Claire Mazumdar added, “Ficerafusp alfa, the first and only bifunctional EGFR‑directed antibody x TGF‑β ligand trap, was purposefully designed to deliver deep and durable responses with the potential to meaningfully extend overall survival for patients.”
The data were well received by the oncology community, with clinicians noting the potential for improved patient convenience and the ability to maintain efficacy with a less frequent dosing schedule. The company’s strong liquidity position, with $407.6 million in cash and a current ratio of 14.14, supports continued investment in clinical development and regulatory engagement.
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