Bicara Therapeutics (NASDAQ:BCAX) said new data to be presented at the 2026 American Society of Clinical Oncology annual meeting support the clinical profile of ficerafusp alfa, also referred to by the company as Ficara, in first-line recurrent or metastatic HPV-negative head and neck cancer.
On an investor call, Chief Executive Officer Claire Mazumdar said the ASCO update includes two posters and represents “the most comprehensive and mature clinical data set” the company has assembled for ficerafusp alfa in this setting. The data span approximately 90 patients across three dose cohorts, with up to three years of follow-up at the 1,500 milligram weekly dose now being evaluated in the company’s pivotal Phase III FORTIFY-HN01 study.
Ficerafusp alfa is a bifunctional EGFR-directed antibody combined with a TGF-beta ligand trap. Mazumdar said the drug is designed to target tumors through EGFR while modulating the tumor microenvironment through TGF-beta inhibition, with the goal of improving immune-cell penetration and reducing resistance mechanisms.
Company Highlights Three-Year Survival Data
Mazumdar said the 1,500 milligram weekly dose of ficerafusp alfa plus pembrolizumab showed a 31% overall survival rate at approximately three years. She compared that with about 15% overall survival at nearly three years for pembrolizumab monotherapy in a real-world study of HPV-negative patients.
The company noted that recurrent or metastatic HPV-negative head and neck cancer remains an area of significant unmet need. Mazumdar said standard-of-care pembrolizumab has shown response rates of 19% as a single agent and 36% in combination with chemotherapy, while median overall survival remains about 12 to 13 months in the broader population. She added that real-world data in HPV-negative disease show worse survival outcomes, as low as seven to nine months.
Chief Medical Officer Bill Schelman said the mature 1,500 milligram weekly cohort showed median overall survival of 21.3 months. He said the 750 milligram weekly and 2,000 milligram every-other-week cohorts are still maturing, but early overall survival trajectories are trending toward the 1,500 milligram cohort.
Responses Deepened Across Dose Cohorts
The three cohorts evaluated in the Phase Ib study were 750 milligrams weekly, 1,500 milligrams weekly and 2,000 milligrams every other week. According to the company, all three cohorts showed high and consistent overall response rates, while deeper responses were more pronounced at higher doses.
Schelman said that in the 1,500 milligram weekly cohort, 80% of responders achieved a “deep response,” defined as more than 80% tumor reduction. In the 2,000 milligram every-other-week cohort, 77% of responders achieved deep responses. He said complete response rates increased in each cohort compared with prior presentations.
The company also reported progression-free survival across the three dose cohorts:
- 6.9 months at 750 milligrams weekly;
- 9.9 months at 1,500 milligrams weekly;
- 12.7 months at 2,000 milligrams every other week.
Schelman compared those figures with a median progression-free survival of 3.2 months for pembrolizumab in an HPV all-comer population. He said the 2,000 milligram every-other-week result supports further development of the company’s loading and maintenance dosing approach.
For duration of response, Schelman said the 1,500 milligram cohort had a mature median duration of response of 21.7 months at a prior two-year update. He said the 750 milligram and 2,000 milligram cohorts are still maturing but have surpassed approximately 17 months and 13 months, respectively.
Biomarker Data Support TGF-Beta Mechanism, Company Says
Schelman said updated biomarker analyses showed sustained TGF-beta neutralization in plasma across all three dose cohorts. He also said the company observed intra-tumoral reductions in phospho-Smad2, a pharmacodynamic marker of TGF-beta pathway inhibition, across all three doses.
The company also reported increased CD8-positive T-cell infiltration in paired biopsies, reaching statistical significance in the 1,500 milligram weekly and 2,000 milligram every-other-week dose groups. Schelman said the findings support the company’s view that TGF-beta inhibition enables immune cells to enter tumors and drive immune activation at the disease site.
In a separate analysis combining the three cohorts, Bicara compared patients with more than 80% tumor shrinkage against responders with 30% to 80% shrinkage. Schelman said deep responders had a median progression-free survival of 37 months and median overall survival had not yet been reached. He said deep responders were 65% more likely to remain progression-free and 63% more likely to remain alive, corresponding to hazard ratios of 0.35 and 0.37, respectively.
Safety Profile Remains Consistent
As of a March 31, 2026, data cutoff, Schelman said ficerafusp alfa continued to show a generally well-tolerated safety profile across all three dose cohorts, with no new safety signals. He said hypothesized TGF-beta-related adverse events, including mucosal bleeds, gingival bleeds and epistaxis, were generally low grade.
In response to an analyst question about safety for TGF-beta traps, Schelman said the treatment-related adverse event profile was consistent with the drug’s mechanism, with skin toxicity being the most common effect associated with EGFR inhibition. He said anemia and low-grade non-mucosal bleeding were observed in connection with TGF-beta biology, but anemia had been managed with iron supplementation and supportive measures.
Ryan Cohlhepp, Bicara’s president and chief operating officer, said the company had designed the molecule’s TGF-beta trap with the extracellular domain of TGF-beta receptor 2 in an effort to mitigate historical safety concerns associated with TGF-beta approaches.
FORTIFY-HN01 and Dosing Plans
Bicara executives said the ASCO data increase their confidence in the Phase III FORTIFY-HN01 trial, including its overall response rate-based interim analysis and confirmatory overall survival endpoint. Cohlhepp said the trial’s inclusion and exclusion criteria are consistent with the Phase Ib study and were designed with the KEYNOTE-048 trial in mind as a historical anchor.
The company also discussed a planned maintenance dosing strategy involving 1,500 milligrams weekly for 12 weeks followed by 2,250 milligrams every three weeks. Cohlhepp said the maintenance dose was selected because it replicates the 750 milligram weekly exposure profile on a pharmacokinetic basis, while the initial weekly phase is intended to drive rapid and deep responses.
Mazumdar said the company intends to begin the design of the every-three-week maintenance study in the third quarter and aims to have progression-free survival data available by the time of a potential approval. Cohlhepp also said Bicara is conducting feasibility work on a possible subcutaneous formulation, though the near-term focus is on developing the every-three-week maintenance regimen.
About Bicara Therapeutics (NASDAQ:BCAX)
Bicara Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel neurohormone-based therapies for psychiatric and neurological disorders. The company's research focuses on harnessing endogenous signaling pathways in the brain, with the goal of offering new treatment options for conditions that remain inadequately addressed by existing medications. Bicara applies proprietary peptide engineering and intranasal delivery platforms to optimize central nervous system uptake and therapeutic effect.
The company's lead candidates include PST-001, an intranasal vasopressin-1A receptor antagonist in development for postpartum depression, and PST-002, an oxytocin receptor modulator being investigated for social anxiety and autism spectrum disorder.
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