Kelun-Biotech Announces Phase III Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First-Line Treatment for PD-L1-Negative Non-Squamous NSCLC Met Primary Endpoint

Kelun-Biotech announced that its Phase III study OptiTROP-Lung06 of sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870) plus pembrolizumab has met the primary endpoint of progression-free survival (PFS) at a prespecified interim analysis. The trial is designed as a first-line treatment study for PD-L1-negative locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Conducted with the independent data monitoring committee concluding results, it targets a population considered particularly challenging and compares the investigational approach with standard immunotherapy plus chemotherapy. The company said the strategy replaces conventional pemetrexed/platinum chemotherapy with sac-TMT and reports a significantly prolonged PFS and a positive overall survival trend versus pembrolizumab plus pemetrexed and platinum. Kelun-Biotech also referenced OptiTROP-Lung05, where sac-TMT plus pembrolizumab previously met a primary endpoint in PD-L1-positive NSCLC. The study is described as the first Phase III of an antibody-drug conjugate combined with an immune checkpoint inhibitor to meet its primary endpoint in first-line driver gene-negative, PD-L1-negative non-squamous NSCLC.