Junshi Biosciences, a China-based biopharmaceutical company, and Merck have entered a collaboration for a clinical trial program 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.

Head and neck cancer is one of the most common cancer types in China, with more than 135,000 new cases each year and about 70,000 deaths.

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).

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.  

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.