Bicara Therapeutics Makes a Strong Showing: Data from Ficerafusp Alfa Trial Signals Promising Results in Head and Neck Cancer
BOSTON, June 01, 2025 – Emerging from the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Bicara Therapeutics Inc. (BCAX), a clinical-stage biopharmaceutical firm, unveiled compelling new data from its Phase 1/1b trial of ficerafusp alfa in combination with pembrolizumab. The focus is on patients battling first-line recurrent/metastatic (1L R/M) head and neck squamous cell carcinoma (HNSCC). Ficerafusp alfa, a first-in-class bifunctional antibody, is engineered to penetrate the complex tumor microenvironment, potentially revolutionizing the treatment landscape for various solid tumors. This approach leverages two clinically validated targets: an epidermal growth factor receptor (EGFR) antibody and a domain targeting human transforming growth factor beta (TGF-β).
“Our goal with ficerafusp alfa has been to reshape the tumor microenvironment, facilitating deeper and more durable responses,” stated Dr. David Raben, Chief Medical Officer of Bicara Therapeutics. “The clinical outcomes are starting to validate this approach with responses nearing two years and a significant improvement in overall survival for HPV-negative patients – a group often facing grim prognoses.” The data highlighted a median duration of response (DOR) of 21.7 months, with 80% of responders achieving a deep response, defined as at least 80% tumor shrinkage. Median overall survival (OS) reached an impressive 21.3 months, culminating in a two-year OS rate of 46%. This collective data bolsters the continued advancement of FORTIFI-HN01, Bicara’s pivotal Phase 2/3 trial tailored for the first-line recurrent/metastatic setting.
Key takeaways from the presentation include:
* In the Phase 1/1b trial, the combination of ficerafusp alfa and pembrolizumab showed robust antitumor activity, with extended overall survival compared to historical data, specifically in patients with 1L R/M HPV-negative HNSCC (PD-L1 CPS ≥1) who had at least 24 months of follow-up.
* Analyzing the HPV-negative patient cohort (n=28) further unveiled:
* A median duration of response of 21.7 months among responders (n=15).
* A median overall survival of 21.3 months and a remarkable 2-year OS rate of 46%.
* An overall response rate (ORR) of 54% (15/28), further amplified to 64% (18/28) when including unconfirmed responses, including a 21% complete response rate.
* An impressive 80% (12/15) of responders achieved a deep response, indicating significant tumor shrinkage.
* A commendable disease control rate of 89% (25/28 patients).
* A median progression-free survival of 9.9 months.
* A manageable safety profile, consistent with established adverse event profiles.
“These latest Phase 1/1b results are particularly impressive, especially the duration of response,” commented Dr. Christine H. Chung, Chair of the Department of Head and Neck-Endocrine Oncology and Deputy Physician-in-Chief at the Moffitt Cancer Center. “This shows ficerafusp alfa’s ability to reshape the tumor environment, allowing the immune cells to effectively reach and attack the tumors, leading to deep and durable results. The prolonged overall survival, backed by a median OS of 21.3 months, reinforces the potential of ficerafusp alfa to address a critical unmet need, delivering significant tumor response and raising the patient’s quality of life.”
Bicara Therapeutics will discuss these findings further in a conference call and webcast later today.
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