Bicara’s Bifunctional Antibody Shows Promise in Head & Neck Cancer, Data Due at ESMO Asia

November 10, 2025 - Cambridge, MA – Bicara Therapeutics is poised to present updated data on its lead investigational asset, ficerafusp alfa, at the upcoming ESMO Asia Congress in Singapore. The novel bifunctional antibody is demonstrating encouraging early clinical results in patients with advanced head and neck squamous cell carcinoma (HNSCC), and recently received Fast Track designation from the FDA. Experts believe this innovative approach could address a significant unmet need in this particularly aggressive cancer.

A New Approach to a Difficult Cancer

HNSCC, especially the non-HPV-associated variety, remains a challenging cancer to treat. Traditional therapies, including chemotherapy, radiation, and surgery, often have limited efficacy and can cause significant side effects. While immunotherapy has revolutionized cancer treatment, many HNSCC patients do not respond, highlighting the need for new therapeutic strategies.

“The biggest hurdle in treating advanced HNSCC is overcoming the tumor’s ability to suppress the immune system and create a hostile microenvironment,” explains a leading oncologist familiar with the research, speaking anonymously. “Current immunotherapies often struggle to penetrate this barrier. Bicara’s approach, targeting both the cancer cells and the tumor microenvironment, is a potentially game-changing strategy.”

How Ficerafusp Alfa Works

Ficerafusp alfa is a first-in-class bifunctional antibody designed to simultaneously target two key pathways in the tumor microenvironment: Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). EGFR is frequently overexpressed in HNSCC and drives cancer cell proliferation, while TGF-β creates a fibrotic, immunosuppressive barrier that shields the tumor from immune attack.

“By targeting both pathways simultaneously, ficerafusp alfa aims to ‘unlock’ the tumor microenvironment, allowing immune cells to infiltrate and effectively kill cancer cells,” explains another oncology expert, also speaking anonymously. “It's a clever design that addresses a critical limitation of existing therapies.”

Promising Early Data & Fast Track Designation
The encouraging early clinical results were based on a Phase 1/1b trial, which demonstrated deep and durable responses in heavily pretreated patients. The trial showed an overall response rate of 64%, with a complete response rate of 18%, and a median duration of response of 21.7 months. Importantly, the data suggested a manageable safety profile.

The promising results earned ficerafusp alfa Fast Track designation from the FDA, which is designed to accelerate the development and review of innovative therapies for serious conditions with unmet medical needs.

FORTIFI-HN01: A Pivotal Trial Underway

Building on the encouraging early data, Bicara is currently conducting a pivotal Phase 2/3 trial, known as FORTIFI-HN01. This global, randomized, double-blinded, placebo-controlled trial is evaluating ficerafusp alfa in combination with pembrolizumab (Keytruda), a checkpoint inhibitor, as a first-line treatment for patients with recurrent or metastatic HPV-negative HNSCC.

The trial is expected to enroll approximately 650 patients and is assessing overall response rate and overall survival as primary endpoints. Secondary endpoints include progression-free survival, duration of response, and quality of life.

“The design of the FORTIFI-HN01 trial is rigorous and well-designed,” notes a clinical trial specialist familiar with the program. “If the results are positive, this combination could become a new standard of care for patients with this devastating disease.”

What to Expect at ESMO Asia
The upcoming ESMO Asia Congress in Singapore will provide a valuable opportunity to see updated data from the Phase 1/1b expansion cohort. While specific details remain under wraps, analysts expect the presentation to include longer follow-up data, further insights into biomarker analysis, and a more comprehensive assessment of the safety profile.

“The ESMO Asia presentation is highly anticipated,” says a biotechnology analyst covering Bicara Therapeutics. “The company is likely to showcase the potential of ficerafusp alfa as a first-in-class therapy and demonstrate its ability to overcome the limitations of existing treatments.”

Looking Ahead

Bicara Therapeutics is at the forefront of developing innovative therapies for HNSCC. With its unique bifunctional antibody approach and promising clinical data, the company is well-positioned to make a significant impact on the lives of patients with this aggressive cancer. The ongoing FORTIFI-HN01 trial and the upcoming presentation at ESMO Asia will be key milestones in determining the future of ficerafusp alfa and its potential to transform the treatment landscape for HNSCC.

Disclaimer: This article is for informational purposes only and should not be considered medical advice. Consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.