China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its bispecific antibody, MCLA-129, in combination with befotertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The treatment targets patients with deletion of Exon 19 of the epidermal growth factor receptor (EGFR) or replacement mutation of Exon 21 (L858R).
MCLA-129: A Promising Approach for Advanced Solid Tumors
MCLA-129 is a bispecific antibody targeting both EGFR and c-Mesenchymal-epithelial transition factor (c-Met). It is currently under clinical investigation for advanced solid tumors with EGFR or MET abnormalities. This innovative approach aims to address the complex landscape of EGFR-driven malignancies.
Befotertinib: A Third-Generation EGFR-TKI
Befotertinib, co-developed by InventisBio (SHA: 688382), is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). InventisBio granted Betta Pharmaceuticals the development and commercialization rights for befotertinib in China mainland, Hong Kong, and Taiwan in a licensing deal in December 2018. The drug was approved in China to treat locally advanced or metastatic NSCLC with the EGFR T790M mutation in May this year, following progression after initial EGFR-TKI treatment. Regulatory decisions for its use in the first-line treatment of NSCLC are pending in the country.-Fineline Info & Tech
