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Junshi Biosciences, a China-based biopharmaceutical company specializing in discovery, development and commercialization of novel therapies, and Merck, a world leading science and technology company, announced their collaboration on a clinical trial program designed to investigate the efficacy and safety of anti-PD-1 mAb toripalimab (TUOYI®) in combination with Cetuximab (Erbitux®) as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck (R/M SCCHN) in China.
Cetuximab (Erbitux®) is an IgG1 monoclonal antibody that specifically targets the EGFR. The inhibition of EGFR blocks the processes involved in tumor cell growth and progression. Cetuximab is also a potent inducer of antibody-dependent cell mediated cytotoxicity (ADCC), inducing antitumor immune effect. In February 2020, Cetuximab was granted an approval by China’s National Medical Products Administration (NMPA) for the first-line treatment of R/M SCCHN using a combination chemotherapy regimen (platinum plus 5-FU).
Developed by Junshi Biosciences, toripalimab (TUOYI®) is the first domestically marketed PD-1 monoclonal antibody in China. Anti-PD-1 mAb is an immunotherapy that can activate and direct the body’s own immune system to attack tumor cells by inhibiting the PD-1 pathway. Over 30 toripalimab mono and combo clinical trials have been conducted globally for more than 10 tumor types, and show encouraging anti-tumor outcomes.
Cetuximab and PD-1 inhibitors are believed to have a synergistic mechanism of action in SCCHN treatment. Preliminary data of early-phase studies have shown promising results from combining immune checkpoint inhibitors with cetuximab.
