Kelun-Biotech's cancer drug shows efficacy in PD-L1-negative lung cancer
Kelun-Biotech's sacituzumab tirumotecan combined with pembrolizumab met its primary endpoint in a Phase III trial for first-line treatment of PD-L1-negative non-squamous NSCLC.
Sichuan Kelun-Biotech Biopharmaceutical announced on July 14, 2026, that its cancer drug, sacituzumab tirumotecan (sac-TMT), in combination with pembrolizumab, has met its primary endpoint in a Phase III clinical study. The study focused on the first-line treatment for PD-L1-negative non-squamous non-small cell lung cancer (NSCLC), yielding significant results.
The primary objective was to improve progression-free survival (PFS). The trial demonstrated that the combination of sac-TMT and pembrolizumab was superior to the current standard of care: pembrolizumab combined with conventional chemotherapy (pemetrexed and platinum). A positive trend in overall survival (OS) was also observed.
The Phase III, randomized, open-label, multicenter study, named OptiTROP-Lung06, evaluated the efficacy and safety of the treatments in patients with a PD-L1 tumor proportion score (TPS) of less than 1%. Kelun-Biotech stated this marks the first time globally that a combination of an antibody-drug conjugate and an immune checkpoint inhibitor has met its primary endpoint in a Phase III trial for this patient population.
Kelun-Biotech CEO Michael Ge expressed satisfaction with the findings. The company plans to consult with China's regulatory authorities regarding the results, aiming to expand the drug's application. Previous studies have also shown the efficacy of the sac-TMT combination in PD-L1-positive lung cancer.