Junshi Biosciences announced their collaboration on a clinical trial program designed to investigate the efficacy and safety of anti-PD-1 mAb toripalimab in combination with Cetuximab as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck in China. Cetuximab 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, inducing antitumor immune effect. In February 2020, Cetuximab was granted an approval by China’s National Medical Products Administration for the first-line treatment of R/M SCCHN using a combination chemotherapy regimen.
Developed by Junshi Biosciences, toripalimab 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.