NMPA accepted the new indication application for sac-TMT plus pembrolizumab as 1L treatment for PD-L1-negative non-squamous NSCLC

CAR-T Digest - August 2020

Weekly Digest - October 2026

27 October 2026: NMPA accepted the new indication application for sac-TMT plus pembrolizumab as 1L treatment for PD-L1-negative non-squamous NSCLC

Kelun-Biotech announced that China’s NMPA has accepted for review a new indication application for Sacituzumab tirumotecan in combination with Pembrolizumab as first-line treatment for adults with locally advanced or metastatic, EGFR-negative and ALK-negative, PD-L1-negative non-squamous non-small cell lung cancer. This marks the seventh indication application for sac-TMT accepted for review in China
The application is supported by the phase 3 OptiTROP-Lung06 trial, where sac-TMT plus pembrolizumab significantly improved median progression-free survival (PFS) to 15.0 months versus 5.7 months with pembrolizumab plus pemetrexed and platinum-based chemotherapy (HR = 0.49; p < 0.001). Overall survival data were immature at the interim analysis
The application addresses a major unmet need in first-line PD-L1-negative advanced NSCLC, where outcomes remain poor with standard immunotherapy plus chemotherapy and treatment options are limited for patients without targetable genomic alterations
Sac-TMT is a TROP2-directed ADC that uses a proprietary bifunctional linker to deliver KL610023, a belotecan-derived topoisomerase I inhibitor payload, to tumor cells. Pembrolizumab is a PD-1 immune checkpoint inhibitor that enhances antitumor immune responses, providing a rationale for combining targeted cytotoxic delivery with immunotherapy
Strategically, the application advances sac-TMT’s ADC-immunotherapy combination into the PD-L1-negative first-line NSCLC setting, following progress in PD-L1-positive disease. Positive phase 3 results could broaden the combination’s role in first-line lung cancer and reinforce the potential of ADC-immunotherapy regimens as alternatives to conventional chemotherapy-containing treatment