Sichuan Kelun-Biotech Biopharmaceutical Company has announced a major milestone for its first-line lung cancer therapy trial.

According to the company, the Independent Data Monitoring Committee (IDMC) has shown satisfaction in the Phase III OptiTROP-Lung05 study that evaluated TROP2-targeted therapy, sacituzumab tirumotecan (sac-TMT), in combination with US pharma giant Merck's KEYTRUDA (pembrolizumab), as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC).

The study “has demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS),” the trial’s primary endpoint. A “positive trend in overall survival” was also observed.

“This is the first Phase III clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC,” the company said.

OptiTROP-Lung05 is a randomized, open-label, multicenter study comparing sac-TMT plus pembrolizumab to pembrolizumab alone in patients with PD-L1-positive locally advanced or metastatic NSCLC. At a pre-specified interim analysis, the combination therapy showed a statistically significant and clinically meaningful PFS improvement.

Based on these results, Kelun-Biotech plans to discuss a supplemental new drug application (sNDA) submission with China’s Center for Drug Evaluation (CDE).

Sac-TMT is already approved in China for EGFR-mutant NSCLC in second-line and later settings and has shown “dual benefits in PFS and overall survival (OS)” in EGFR-TKI-resistant lung cancer patients. These findings were published in The New England Journal of Medicine and The BMJ.

The therapy is currently being evaluated in ten registrational lung cancer studies globally, including five in China and five multicenter Phase III trials.

Sac-TMT, Kelun-Biotech’s core product, is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors such as NSCLC, breast, gastric, and gynecological cancers.