Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

Shots: The Chinese NMPA has approved sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy & ≥1L of CT in an advanced setting Approval was based on the P-III (OptiTROP-Breast02) trial assessing sac-TMT vs CT for the…

ByRidhi RastogiFebruary 6, 2026

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Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung05) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs Keytruda monotx. as a 1L treatment for PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥1% The trial met its 1EP of improved PFS, as concluded by IDMC & showed a favorable trend in the OS Additionally, the company…

ByRidhi RastogiNovember 25, 2025

Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC

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