Kelun-Biotech announces phase 3 trial of Sacituzumab Tirumotecan versus Chemotherapy as 1L treatment for advanced TNBC met primary endpoint of PFS

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21 May 2026: Kelun-Biotech announces phase 3 trial of Sacituzumab Tirumotecan versus Chemotherapy as 1L treatment for advanced TNBC met primary endpoint of PFS

Sichuan Kelun-Biotech Biopharmaceutical announced that the Phase 3 OptiTROP-Breast03 trial evaluating Sacituzumab Tirumotecan as a first-line treatment for unresectable locally recurrent or metastatic triple-negative breast cancer met its primary endpoint of progression-free survival at a prespecified interim analysis
The study demonstrated a statistically significant and clinically meaningful improvement in PFS versus investigator’s choice chemotherapy, marking the first registrational Phase 3 trial of sac-TMT to achieve positive results in the first-line TNBC setting
The randomized, open-label, multicenter study enrolled patients with PD-L1-negative disease as well as patients with PD-L1-positive TNBC who relapsed after prior anti-PD-(L)1 therapy in early-stage disease, highlighting sac-TMT’s potential across difficult-to-treat patient populations
While overall survival data remain immature, an early positive trend has been observed, and the safety profile remained consistent with previous studies, with no new safety signals identified during the interim analysis
Building on earlier approvals in China across TNBC, NSCLC, and HR+/HER2- breast cancer, Kelun-Biotech plans to engage with China’s CDE on the regulatory pathway for sac-TMT, while global development continues through multiple ongoing Phase 3 TroFuse studies led by Merck & Co.