Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced the first patient dosed in the global multi-center Phase III TROPION-Lung08 study in China. The trial is assessing the efficacy and safety of Dato-DXd combined with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 without driver gene mutation, compared with pembrolizumab alone.
Trial Design and Objectives
TROPION-Lung08 is the world’s first trial to assess a TROP2 ADC as a first-line NSCLC therapy. The primary endpoints are progression-free survival (PFS) and overall survival (OS), while the study is expected to enroll about 740 patients in multiple locations in Asia, Europe, North America, and South America.
Dato-DXd: Technology and Partnership
DATO-DXd (datopotamab deruxtecan, DS-1062a), one of Daiichi Sankyo’s three core Dxd antibody-drug conjugates (ADCs), was designed using DXd ADC technology and composed of a humanized TROP2 IgG1 monoclonal antibody, topoisomerase I inhibitor (camptothecin derivatives), and a cleavable tetrapeptide linker, with a 4-drug antibody ratio (DAR). The company struck a partnership with UK major AstraZeneca in July 2020, to co-develop and commercialize the drug around the globe except for Japan. Daiichi Sankyo is conducting the TROPION-Lung08 study on behalf of both firms, as per the agreement.-Fineline Info & Tech
