Kelun-Biotech’s phase 3 trial of Sac-TMT plus Pembrolizumab met the primary endpoint in 1L PD-L1-negative non-squamous NSCLC

CAR-T Digest - August 2020

Weekly Digest - July 2026

15 July 2026: Kelun-Biotech’s phase 3 trial of Sac-TMT plus Pembrolizumab met the primary endpoint in 1L PD-L1-negative non-squamous NSCLC

Kelun-Biotech announced that its TROP2-targeted antibody-drug conjugate Sacituzumab tirumotecan, in combination with pembrolizumab, met the primary endpoint of progression-free survival in the phase 3 OptiTROP-Lung06 trial as first-line treatment for patients with PD-L1-negative locally advanced or metastatic non-squamous NSCLC
The randomized phase 3 OptiTROP-Lung06 study demonstrated a statistically significant improvement in PFS over pembrolizumab plus chemotherapy at the pre-specified interim analysis. Detailed efficacy and safety data will be presented at a future scientific meeting
The positive outcome expands the clinical evidence for sac-TMT beyond PD-L1-positive disease, following the successful phase 3 OptiTROP-Lung05 study, and has the potential to extend the benefit of the ADC-immunotherapy strategy to a broader first-line NSCLC population with limited treatment options
Sacituzumab tirumotecan is a TROP2-directed ADC that combines a humanized anti-TROP2 antibody with a proprietary topoisomerase I inhibitor payload through a cleavable linker, enabling targeted intracellular delivery of cytotoxic therapy while maintaining a favorable therapeutic profile
Strategically, the successful OptiTROP-Lung06 trial further strengthens Kelun-Biotech’s leadership in TROP2-targeted ADC development, reinforces the clinical potential of ADC-immunotherapy combinations in first-line NSCLC, and supports the company’s strategy of expanding sac-TMT across multiple lung cancer populations and treatment settings