Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) announced that an Independent Data Monitoring Committee has confirmed the Phase 3 OptiTROP-Lung06 trial met its primary endpoint. The study evaluated sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870) combined with pembrolizumab as first-line therapy for PD-L1-negative, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

The randomized, open-label, multicenter trial compared sac-TMT + pembrolizumab with the current standard regimen of pembrolizumab plus pemetrexed and platinum chemotherapy. Blinded independent central review confirmed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the sac-TMT arm at the pre-specified interim analysis. A positive overall survival trend was also observed. Safety findings were consistent with prior studies and revealed no new signals.

OptiTROP-Lung06 is the world’s first Phase 3 study in which an antibody–drug conjugate (ADC) combined with an immune checkpoint inhibitor achieved its primary endpoint in driver gene-negative, PD-L1-negative, first-line non-squamous NSCLC. Kelun-Biotech plans to engage China’s National Medical Products Administration (NMPA) Center for Drug Evaluation regarding a potential filing based on these data.

The result follows the earlier success of OptiTROP-Lung05, in which sac-TMT plus pembrolizumab met the primary endpoint as first-line therapy for PD-L1-positive NSCLC. That dataset was presented orally at the 2026 ASCO Annual Meeting and published in The Lancet, underpinning an ongoing new-indication review by the NMPA.

Sac-TMT overview • First TROP2-targeting ADC approved globally for lung cancer. • Four China-approved indications to date, including triple-negative breast cancer and EGFR-mutant NSCLC; two are listed on the National Reimbursement Drug List. • Six NMPA Breakthrough Therapy Designations granted. • Ten registrational studies active in China; MSD (Merck & Co.) is leading 17 global Phase 3 trials under its ex-Greater China license signed in May 2022.

Risk reminder Sac-TMT is not yet approved for several investigated indications. Shareholders and potential investors should exercise caution when dealing in Kelun-Biotech securities.