Kelun-Bota Biopharma (06990) has announced that a new supplemental New Drug Application (sNDA) for its TROP2-targeting antibody-drug conjugate (ADC), sacituzumab govitecan (sac-TMT, also known as SKB264/MK-2870), has been accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The application seeks approval for sac-TMT in combination with Merck's anti-PD-1 monoclonal antibody, pembrolizumab, as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have a PD-L1 Tumor Proportion Score (TPS) of 1% or greater, and who are negative for EGFR mutations and ALK rearrangements. This regulatory milestone is supported by positive results from the OptiTROP-Lung05 Phase 3 registrational study. This marks the fifth NDA for sac-TMT accepted by the NMPA. OptiTROP-Lung05 is a randomized, open-label, multicenter Phase 3 clinical trial designed to evaluate the efficacy and safety of sac-TMT combined with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC. A pre-specified interim analysis confirmed that the study met its primary endpoint of Progression-Free Survival (PFS), demonstrating a statistically significant and clinically meaningful improvement, with a trend towards benefit also observed in Overall Survival (OS). Notably, the OptiTROP-Lung05 study is the first Phase 3 trial to meet its primary endpoint evaluating an immunotherapy combined with an ADC in the first-line NSCLC setting. The study's results have also been selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Previously, the combination of sac-TMT and pembrolizumab for this specific patient population had received Breakthrough Therapy Designation (BTD) from the NMPA. On April 9, 2026, the CDE website indicated that this application has been included in a priority review pathway. This is the fifth indication for sac-TMT to be granted priority review status by the CDE, a designation expected to significantly shorten the review timeline and potentially accelerate its path to market.
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