Innovent Biologics, Inc. a biopharmaceutical company that develops, manufactures and commercializes medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany for the combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX) as a potential treatment for NSCLC patients harboring KRASG12C mutation in a Phase 1b clinical trial in China.

Under the agreement, Innovent will conduct a Phase 1b study to evaluate the anti-tumor activity and safety of the combination therapy of IBI351(GFH925) with cetuximab in patients with advanced or metastatic NSCLC harboring KRASG12C mutation. Merck KGaA, Darmstadt, Germany will provide clinical drug supplies of cetuximab in this multi-center trial. Cetuximab as a monotherapy or as a combination therapy has not been approved in any country for patients with advanced NSCLC.

Currently, Innovent is conducting a single arm registrational trial of IBI351(GFH925) monotherapy in previously treated advanced non-small cell lung cancer patients with KRASG12C mutation, with expected NDA filing by the end of 2023.

Meanwhile, a Phase 1b study of IBI351(GFH925) in combination with sintilimab for previously untreated advanced NSCLC patients with KRASG12C mutation is also under exploration. 

Hui Zhou, senior vice president of Innovent, said, “We are pleased to collaborate with Merck KGaA, Darmstadt, Germany to further explore the potential of IBI351 and cetuximab combination therapy in the early line setting for NSCLC patients harboring KRASG12C mutation, and shed light on next-step clinical development. The combination of a KRASG12C inhibitor and an EGFR inhibitor has shown efficacy in heavily pre-treated patients with metastatic colorectal cancer. Preclinical studies of IBI351 and cetuximab combination therapy also demonstrated potential anti-tumor activity in NSCLC.”