China-based Sichuan Kelun-Biotech Biopharmaceutical Co Ltd (HK:6990) announced on Tuesday that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with the PD-L1 monoclonal antibody tagitanlimab has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations.

Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting research, development and marketing to address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study.

It marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA.

Dr Michael Ge, Kelun-Biotech CEO, said: "This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible."