Drug intelligence / Profile preview

ficerafusp alfa + pembrolizumab

Development stage
Phase 3
Lead developer
Bicara Therapeutics
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Ficerafusp alfa + pembrolizumab is an investigational combination therapy under clinical evaluation for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). **Ficerafusp alfa (BCA101)** is a recombinant fusion protein engineered to simultaneously target and inhibit both **Epidermal Growth Factor Receptor (EGFR)** and **Transforming Growth Factor beta (TGF-β)**, two pathways implicated in cancer growth and immune resistance. **Pembrolizumab** is a monoclonal antibody that blocks **programmed cell death protein 1 (PD-1)**, restoring immune response against tumor cells. The combination aims to enhance anti-tumor efficacy through dual pathway inhibition and immune checkpoint blockade. Clinical studies show encouraging antitumor activity, especially in HPV-negative HNSCC, with a manageable safety profile[1][3][5][6].

Other names
BCA101 + pembrolizumab
02

Targets

EGFR (Epidermal growth factor receptor)PDCD1 (Programmed cell death protein 1 receptor)TGFB (GARP–latent transforming growth factor beta 1 complex)

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