FORTIFI-HN01 Trial Enrolls First Patients for Novel HNSCC Therapy
The FORTIFI-HN01 trial has begun enrolling patients with advanced head and neck cancer to evaluate ficerafusp alfa plus pembrolizumab as a first-line therapy.
Head and neck cancer image: © CLIPAREA.com- stock.adobe.com
The first patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) have been enrolled in the phase 2/3 FORTIFI-HN01 trial (NCT06788990) and treated with the combination of ficerafusp alfa (BCA101) and pembrolizumab (Keytruda) in the first-line.1
Ficerafusp alfa is a novel bifunctional antibody designed to target 2 clinically validated pathways in cancer therapy. It combines an epidermal growth factor receptor (EGFR)-directed monoclonal antibody with a domain that binds to transforming growth factor beta (TGF-β).
By simultaneously inhibiting EGFR-driven tumor cell survival and proliferation while counteracting the immunosuppressive effects of TGF-β within the tumor microenvironment, ficerafusp alfa holds promise for enhancing antitumor activity through a dual-targeting approach.1
“This is a key milestone for Bicara and represents our transition into a late-stage clinical development company,” said David Raben, MD, chief medical officer of Bicara Therapeutics, in a press release. “Supported by encouraging interim phase 1/1b data, which demonstrated durable and clinically meaningful anti-tumor activity with ficerafusp alfa in combination with pembrolizumab, FORTIFI-HN01 will evaluate the potential of ficerafusp alfa as a first-in-class treatment option for patients with advanced head and neck squamous cell carcinoma. The thoughtful and efficient design of this trial underscores our strategic approach to rapidly advancing treatment options for these patients, with the goal of addressing the significant unmet needs in this challenging disease.”
The FORTIFI-HN01 study is a global, randomized, double-blinded, placebo-controlled, phase 2/3 trial designed to evaluate the efficacy of ficerafusp alfa in patients with R/M HNSCC. The study plans to enroll approximately 650 patients, excluding those with human papillomavirus-positive oropharyngeal squamous cell carcinoma.
Enrollment in the trial is open to patients with a PD-L1 combined positive score of ≥1 and must not have received prior systemic therapy in the recurrent/metastatic setting.
In phase 2 of the study, patients will be randomized to 1 of 3 treatment arms at a 1:1:1 ratio.2 Arm A will administer patients ficerafusp alfa 1500 mg once weekly (QW) with pembrolizumab 200 mg every 3 weeks (Q3W). In arm B, patients will be given ficerafusp alfa 750 mg QW with pembrolizumab 200 mg Q3W. Finally, patients in arm C, the control arm, will receive placebo QW with pembrolizumab 200 mg Q3W.
The trial’s primary end points include overall response rate based on RECIST v1.1 and overall survival, with the potential to support regulatory filings for accelerated and full approval. Secondary end points include progression-free survival and duration of response, providing additional insights into the treatment’s long-term efficacy and clinical benefit.
“Head and neck squamous cell carcinoma is a cancer of growing concern across the world,” said John Kaczmar, MD, Medical University of South Carolina Hollings Cancer Center, in the press release.1 “Incidence is rising, yet survival rates remain low, particularly for patients with HPV-negative disease, underscoring the urgent need for innovative treatment options. I’m encouraged by the early signs of clinical activity in these patients we have seen treated with ficerafusp alfa and hopeful it will help address this area of significant unmet need. I look forward to contributing to this important trial to advance new possibilities for our patients.”
REFERENCES:
1. Bicara Therapeutics announces first patients enrolled in FORTIFI-HN01, a pivotal phase 2/3 clinical trial of ficerafusp alfa in 1L recurrent/metastatic head and neck squamous cell carcinoma. Bicara Therapeutics Inc. February 11, 2025. Accessed February 11, 2025. https://tinyurl.com/zvd3yzrr
2. FORTIFI-HN01: a study of ficerafusp alfa (BCA101) or placebo in combination with pembrolizumab in first-line PD-L1-pos, R or M HNSCC (FORTIFI-HN01). ClinicalTrials.gov. Updated January 27, 2025. Accessed February 11, 2025. https://clinicaltrials.gov/study/NCT06788990
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