Sacituzumab tirumotecan (Sac-TMT) approved for marketing for third indication by the National Medical Products Administration in EGFRm NSCLC following progresssion on EGFR-TKI therapy

CAR-T Digest - August 2020

Weekly Digest - October 2025

12 October 2025: Sacituzumab tirumotecan (Sac-TMT) approved for marketing for third indication by the National Medical Products Administration in EGFRm NSCLC following progresssion on EGFR-TKI therapy

Sichuan Kelun-Biotech announced that its TROP2-directed ADC, sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870), received marketing approval from the NMPA for its third indication the treatment of EGFR-mutant locally advanced or metastatic non-squamous NSCLC patients who progressed after EGFR-TKI therapy
The approval was supported by data from the Phase 3 OptiTROP-Lung04 trial, a randomized, open-label, multicenter study comparing sac-TMT (5 mg/kg Q2W) monotherapy against pemetrexed plus platinum chemotherapy in EGFR-mutant NSCLC patients, which showed clinically meaningful improvements in both PFS and OS
Sac-TMT becomes the first and only ADC worldwide to demonstrate a statistically significant overall survival (OS) benefit compared with platinum doublet chemotherapy, marking a new standard in second-line therapy for advanced NSCLC post-TKI progression
The pivotal OptiTROP-Lung04 results have been recognized as a late-breaking abstract (LBA5) and will be presented in the Presidential Symposium at ESMO 2025, emphasizing the clinical significance of sac-TMT’s findings in the global oncology landscape
Following its previous approvals, sac-TMT continues to expand its clinical reach, with ongoing Phase 3 trials evaluating sac-TMT plus osimertinib as first-line therapy for EGFR-mutant NSCLC, reflecting Kelun-Biotech’s strategic goal to position sac-TMT as a cornerstone therapy across multiple stages of lung cancer treatment