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

About this update from Sichuan Kelun-biotech Biopharmaceutical Co., Ltd. Class H

CHENGDU, China, July 14, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced today that the Independent Data Monitoring Committee (IDMC) concluded that the 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) (佳泰莱®), in combination with MSD's[1] anti-programmed cell death protein 1 (PD-1) therapy KEYTRUDA®[2] (pembrolizumab) 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) has met its primary endpoint of progression‑free survival (PFS) at a prespecified interim analysis. 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 randomized, open‑label, multicenter 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 tumor proportion score (TPS) <1%. The primary endpoint of the study was PFS assessed by blinded independent central review (BICR); secondary endpoints included overall survival (OS), safety and others. At a pre-specified interim analysis, the sac-TMT combined with pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in PFS compared with pembrolizumab combined with pemetrexed and platinum-based chemotherapy, and a positive trend in OS was also observed. The safety profile of sac-TMT combined with pembrolizumab was consistent with that observed in previously reported studies, and no new safety signals were observed. The Company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China based on the results of this sac‑TMT study.

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