Final OptiTROP-Lung03 OS: Sac-TMT vs Docetaxel at ELCC 2026

Final survival data from the OptiTROP-Lung03 study are being presented at the 2026 European Lung Cancer Congress (ELCC), comparing sacituzumab tirumotecan (sac-TMT) with docetaxel in EGFR-mutant non–small cell lung cancer (NSCLC). Efficacy readouts spanned progression-free survival (PFS) and a final overall survival (OS) analysis, including unadjusted estimates and crossover-adjusted results. The report also describes regulatory and commercial updates for sac-TMT in connection with the ELCC 2026 disclosure.

For PFS, the study reports a blinded independent central review (BICR)-assessed hazard ratio (HR) of 0.30 (95% CI, 0.20–0.46; p<0.001) for sac-TMT versus docetaxel. Separately, investigator-assessed median PFS was 7.9 months with sac-TMT versus 2.8 months with docetaxel, with an HR of 0.23 (95% CI, 0.15–0.35).

For OS, the median follow-up was 23.8 months and that 41.3% of patients in the control group crossed over to sac-TMT after disease progression. Without crossover adjustment, median OS was 20.0 months for sac-TMT and 13.5 months for docetaxel, with an HR of 0.63 (95% CI, 0.40–0.98). The report then describes use of a rank-preserving structural failure time (RPSFT) model to account for crossover, yielding adjusted median OS of 20.0 months versus 11.2 months (HR, 0.45; 95% CI, 0.28–0.73).

Beyond efficacy, there are several China regulatory and access milestones for sac-TMT, including National Medical Products Administration (NMPA) approval and National Reimbursement Drug List (NRDL) inclusion for two indications, as well as six NMPA Breakthrough Therapy Designations. The article also notes a licensing agreement granting Merck & Co. (MSD) rights outside Greater China, and it reports ongoing development activity comprising 17 global Phase 3 studies run by MSD and 9 registrational studies in China run by Kelun-Biotech.