NMPA Accepts Merck's Pembrolizumab Plus Sac-TMT Filing for First-Line PD-L1-Negative Non-Squamous NSCLC

Prior to this filing, pembrolizumab subcutaneous formulation (KEYTRUDA QLEX, BLA761467) had been approved in the United States across a series of indications, including first-line metastatic nonsquamous NSCLC with no EGFR or ALK aberrations in combination with pemetrexed and platinum chemotherapy . Sacituzumab tirumotecan (sac-TMT, MK-2870) is a TROP2 ADC from Merck/MSD and Kelun's collaboration, with multiple phase 3 studies underway on its combination with pembrolizumab; for example, NCT06422143 (MK-2870-023) evaluates pembrolizumab maintenance with or without sac-TMT in metastatic squamous NSCLC, with overall survival as primary endpoint, planned enrollment of 851 subjects, started June 2024 .

The core facts of this news: MSD has filed in China a marketing application for pembrolizumab subcutaneous formulation plus sac-TMT as first-line treatment for PD-L1 TPS <1% (negative), EGFR mutation-negative, ALK-negative locally advanced or metastatic nonsquamous NSCLC. The application is based on positive results from the phase 3 registrational study OptiTROP-Lung06, head-to-head against pembrolizumab plus chemotherapy standard of care, and the study was selected for LBA at this year's ESMO congress. In June this year, the same combination for first-line treatment in the PD-L1 TPS >=1% population had its application accepted by NMPA, based on the OptiTROP-Lung05 study.

In terms of evidentiary advance, OptiTROP-Lung06 is described in the source material as the first phase 3 study of an immune checkpoint inhibitor plus ADC to reach its primary endpoint in first-line PD-L1-negative nsq-NSCLC, while OptiTROP-Lung05 was previously described as the first IO+ADC regimen with positive phase 3 results in first-line PD-L1-positive NSCLC. With both studies succeeding, the material concludes that IO+ADC replacing IO+chemotherapy has achieved comprehensive clinical breakthrough in first-line NSCLC, the most important indication setting. Note that industry media coverage corresponds to this study; the combination is investigational everywhere, and Merck (MSD) holds sac-TMT rights outside Greater China ; specific efficacy figures have not been disclosed at the regulatory or registry level.

Undisclosed information includes: the review timeline for this application, detailed efficacy and safety data from OptiTROP-Lung06 (expected at ESMO LBA), and filing plans in other regions. Key milestones ahead include the ESMO data presentation, NMPA review progress on the two applications, and readouts from the MK-2870 study series .