NEW YORK – Innovent Biologics on Thursday said China's National Medical Products Administration approved Dupert (fulzerasib) as a treatment for patients with KRAS G12C-altered, advanced non-small cell lung cancer (NSCLC).
Dupert is the first KRAS G12C inhibitor approved in China. Innovent is developing and commercializing Dupert in China, Hong Kong, Macau, and Taiwan with GenFleet Therapeutics under a 2021 license agreement.
Suzhou, China-based Innovent submitted data from a single-arm registrational Phase II trial showing that among 116 evaluable patients, the confirmed objective response rate was 49.1 percent, the disease control rate was 90.5 percent, and the median duration of response was not reached. Patients lived a median of 9.7 months without disease progression or death. Median overall survival was also not reached at the time of analysis.
Innovent is also studying fulzerasib with the anti-EGFR monoclonal antibody Erbitux (cetuximab) in newly diagnosed, advanced NSCLC patients harboring KRAS G12C mutations in partnership with Merck KGaA, and it is evaluating the drug with its PD-1 inhibitor Tyvyt (sintilimab) in the same setting.