The sNDA for Sacituzumab Tirumotecan in combination with Pembrolizumab as 1L treatment for PD-L1 positive NSCLC accepted for review by NMPA

CAR-T Digest - August 2020

Weekly Digest - May 2026

08 May 2026: The sNDA for Sacituzumab Tirumotecan in combination with Pembrolizumab as 1L treatment for PD-L1 positive NSCLC accepted for review by NMPA

Kelun-Biotech has reached another major regulatory milestone after China’s NMPA accepted the sNDA for Sacituzumab tirumotecan plus Pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC, marking the fifth indication filing for the TROP2 ADC in China
The filing is backed by the Phase 3 OptiTROP-Lung05 trial, where sac-TMT combined with Keytruda demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus pembrolizumab alone, while also showing a positive overall survival trend
OptiTROP-Lung05 became the first Phase 3 study of an ADC plus immunotherapy combination to successfully meet its primary endpoint in first-line NSCLC, highlighting the growing potential of ADC-IO combinations to reshape lung cancer treatment
The application has already entered China’s priority review pathway after previously receiving Breakthrough Therapy Designation, potentially accelerating approval timelines for patients with PD-L1-positive, EGFR/ALK-negative NSCLC
With four approved indications already on the market in China and 17 global Phase 3 studies being advanced by MSD, sac-TMT is rapidly emerging as one of the most aggressively developed TROP2 ADC programs worldwide, expanding across multiple tumor types and treatment settings