China-based Innovent Biologics (HKG: 1801) has announced a clinical study and supply agreement with German pharmaceutical giant Merck KGaA (NYSE: MRK). The collaboration aims to explore the combination of Innovent’s KRAS G12C inhibitor, IBI351, and Merck’s Erbitux (cetuximab) in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
Phase Ib Clinical Study and Agreement Details
According to the agreement, Innovent Biologics will conduct a Phase Ib clinical study to assess the safety, tolerability, and preliminary efficacy of the combination therapy in NSCLC patients. Merck will provide cetuximab, a monoclonal antibody not yet approved for the treatment of NSCLC. This study marks a significant step in exploring new treatment options for patients with KRAS G12C-mutated NSCLC.
Innovent Biologics’ IBI351 and Its Potential
Innovent Biologics secured a USD 312 million deal with GenFleet in September 2021, obtaining exclusive development and commercialization rights to IBI351 in Greater China. The drug has received breakthrough therapy designations for use in advanced NSCLC patients with KRAS G12C mutation who have received at least one systemic treatment and advanced colorectal cancer (CRC) with KRASG12C mutation who have received at least two systemic treatments in China.
Erbitux’s Background and Global Approvals
Erbitux, the world’s first IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR), was originally developed by ImClone (now owned by Eli Lilly) and acquired by Merck for ex-North America development in 1998. The drug has an antibody-dependent cytotoxic effect (ADCC) on EGFR-positive tumor cells and has been approved in over 100 countries/regions worldwide for the treatment of RAS wild-type metastatic CRC, locally advanced and recurrent, and/or metastatic head and neck squamous cell carcinoma.-Fineline Info & Tech
