Kelun-Biotech announces Breakthrough Therapy Designation granted in China for Sacituzumab Tirumotecan (sac-TMT) in combination with immunotherapy Pembrolizumab for first-Line treatment of PD-L1-positive NSCLC

CAR-T Digest - August 2020

Weekly Digest - January 2026

05 January 2026: Kelun-Biotech announces Breakthrough Therapy Designation granted in China for Sacituzumab Tirumotecan (sac-TMT) in combination with immunotherapy Pembrolizumab for first-Line treatment of PD-L1-positive NSCLC

The Company has reached a major regulatory milestone as its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT; SKB264/MK-2870), in combination with MSD’s PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®), was granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA)
The designation applies to the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are PD-L1 positive (TPS ≥1%) and lack EGFR and ALK alterations, addressing a significant unmet medical need in this patient population
The BTD decision is supported by robust clinical evidence from the Phase 3 OptiTROP-Lung05 trial, where sac-TMT combined with pembrolizumab delivered a statistically significant and clinically meaningful improvement in progression-free survival, with a favorable trend also observed in overall survival
Notably, OptiTROP-Lung05 is the first Phase 3 study of an ADC-immunotherapy combination to meet its primary endpoint in the first-line NSCLC setting, positioning sac-TMT as a potential new standard of care and accelerating its path toward regulatory approval in China
To date, sacituzumab tirumotecan (sac-TMT) has secured five Breakthrough Therapy Designations (BTDs) across multiple solid tumor indications, reflecting its broad clinical potential. These include triple-negative breast cancer (TNBC) in both later-line and first-line settings, EGFR-mutant non-small cell lung cancer (NSCLC) following EGFR-TKI progression, hormone receptor–positive/HER2-negative breast cancer after multiple prior therapies, and first-line NSCLC in combination with immunotherapy for patients without actionable genomic alterations, with designations granted between July 2022 and June 2025