Chinese pharmaceutical company Sichuan Kelun-Biotech Biopharmaceutical Co Ltd (HK:6990) announced on Tuesday that a Phase III clinical study (OptiTROP-Lung06) of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with MSD's anti-programmed cell death protein 1 (PD-1) therapy KEYTRUDA (pembrolizumab), has met its primary endpoint.

The Independent Data Monitoring Committee (IDMC) concluded that the trial of this combination as a first-line treatment for programmed death-ligand 1 (PD-L1)-negative locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) met the primary endpoint of progression-free survival (PFS) at a prespecified interim analysis.

Kelun-Biotech said that this is the world's first Phase III clinical study of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in the first-line treatment of driver gene-negative and PD-L1-negative non-squamous NSCLC.

OptiTROP-Lung06 is a randomised, open-label, multicentre Phase III clinical study evaluating the efficacy and safety of sac-TMT in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-squamous NSCLC who have PD-L1 tumour proportion score (TPS)