Kelun-Biotech says sac-TMT study selected for oral presentation at ASCO

Two registrational studies of the trophoblast cell-surface antigen 2-directed antibody drug conjugate sacituzumab tirumotecan, or sac-TMT, and the next-generation selective rearranged during transfection inhibitor lunbotinib fumarate from Kelun-Biotech have been selected for oral presentation session on Lung Cancer – Non-Small Cell Metastatic at the 2026 American Society of Clinical Oncology Annual Meeting to be held in Chicago from May 29 to June 2, local time, the company reported. A total of 413 patients with previously untreated locally advanced or metastatic NSCLC without epidermal growth factor receptor or anaplastic lymphoma kinase alterations and with programmed death ligand 1 positive, covering both squamous and non-squamous histologies, were enrolled and randomized to receive sac-TMT plus pembrolizumab or pembrolizumab monotherapy. The primary endpoint was progression-free survival assessed by blinded independent central review, and the key secondary endpoint was overall survival. As of September 29, 2025, the median follow-up was 10.5 months. “OptiTROP-Lung05 is the first Phase III clinical study demonstrating a significant improvement in PFS and a positive trend in OS with an ADC combined with pembrolizumab compared to pembrolizumab in first-line treatment for PD-L1 positive advanced NSCLC. Based on these results, a supplemental New Drug Application for this combination regimen has been accepted for review and included in the priority review and approval process by the National Medical Products Administration (NMPA) in China,” the company stated. In May 2022, the company licensed the exclusive rights to Merck (MRK) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China, which includes Mainland China, Hong Kong, Macao and Taiwan.