Ficerafusp alfa is under clinical development by Bicara Therapeutics and currently in Phase II for Cutaneous Squamous Cell Carcinoma (cSCC). According to GlobalData, Phase II drugs for Cutaneous Squamous Cell Carcinoma (cSCC) have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ficerafusp alfa’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ficerafusp alfa overview

Ficerafusp alfa (BCA-101) is under development for the treatment of solid tumors like squamous cell lung cancer (SqCLC), squamous cell carcinoma of the head and neck (HNSCC), pancreatic cancer, colorectal cancer, squamous non-small cell lung cancer, metastatic or unresectable, recurrent, oropharyngeal cancer, oral cavity (mouth) cancer, cutaneous squamous cell carcinoma, hypopharyngeal cancer, laryngeal cancer, squamous cell carcinoma of the anal canal (SCCAC) and any solid tumor with KRAS mutation. The drug candidate is a fusion protein of a monoclonal antibody against EGFR with TGF beta 2 receptor fragment that binds and neutralizes TGF beta. It is being developed based on technology platform which involves discovery and development of targeted immunoconjugates. It is administered intravenously. It acts by targeting EGFR and TGF beta. The drug candidate was also under development for the treatment of infectious diseases, hepatocellular carcinoma (HCC), anaplastic thyroid cancer (ATC).

Bicara Therapeutics overview

Bicara Therapeutics (Bicara) is a clinical-stage biotechnology company that develops therapies for treating cancer. The company designs and develops dual-action biologics to spur immune response in the tumor microenvironment. Its product pipeline includes a protein-based epidermal growth factor receptor (EGFR), BCA101, and precision immune-cytokine, BCA356. Bicara’s antibodies restrict tumor growth and metastasis by inhibiting EGFR and disabling TGF-ß at the site of the tumor. The company’s bifunctional antibodies and other biologics are used for treating solid tumors. It was funded by Red Tree Venture Capital, RA Capital, F Prime, Eight Roads, Invus, Omega Funds, Piper Sandler, Bioqube Ventures, Acorn, Janus Henderson, Biocon, and Premji Invest. Bicara is headquartered in Cambridge, Massachusetts, the US.

For a complete picture of Ficerafusp alfa’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.