Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, today announced that it 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 frontline treatment for NSCLC patients harboring KRAS^G12C 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 Chinese patients with advanced or metastatic NSCLC harboring KRAS^G12C mutation. Merck KGaA, Darmstadt, Germany will provide clinical drug supplies of cetuximab in this multi-center trial in China. 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 KRAS^G12C mutation in China, with expected NDA filing by the end of 2023. A Phase 1b study of IBI351(GFH925) in combination with sintilimab for previously untreated advanced NSCLC patients with KRAS^G12C mutation is also under exploration. Latest data of a Phase 1 study of IBI351(GFH925) monotherapy in 67 previously-treated NSCLC patients with KRAS^G12C mutation were presented at the 2023 American Association for Cancer Research(AACR) Annual Meeting [Link].

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "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 KRAS^G12C mutation, and shed light on next-step clinical development. The combination of a KRAS^G12C inhibitor and an EGFR inhibitor has shown efficacy in heavily pre-treated patients with metastatic colorectal cancer ^[1],[2],[3]. Preclinical studies of IBI351 and cetuximab combination therapy also demonstrated potential anti-tumour activity in NSCLC. Innovent has observed favorable safety and promising antitumor activity of IBI351 monotherapy in previously-treated advanced NSCLC harboring KRAS^G12C mutation, and we are actively expanding treatment lines, hoping to provide better treatment options for more cancer patients. "