The application covers first-line recurrent or metastatic triple-negative breast cancer in patients with PD-L1 CPS below 10 or relapse after earlier PD-1/PD-L1 therapy, marking sac-TMT's sixth accepted indication filing.
Kelun-Biotech said China’s drug regulator has accepted for review a new indication application for sacituzumab tirumotecan, or sac-TMT, as a first-line treatment for recurrent or metastatic triple-negative breast cancer in patients with PD-L1 combined positive score below 10 or whose disease recurred after prior PD-1/PD-L1 inhibitor therapy at an early stage. The filing, accepted by the Center for Drug Evaluation of the National Medical Products Administration (China drug regulator), is sac-TMT’s sixth indication application accepted by the NMPA and has also entered the priority review and approval process. The submission is backed by positive results from the randomized, open-label, multicenter Phase III OptiTROP-Breast03 registrational study, which compared sac-TMT with investigator’s choice of chemotherapy in patients with unresectable recurrent or metastatic TNBC who had not received prior systemic therapy for advanced disease. Kelun-Biotech said the study showed statistically significant and clinically meaningful improvement in key efficacy measures versus chemotherapy and demonstrated a clear clinical benefit. Sac-TMT previously received Breakthrough Therapy Designation from the NMPA for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1-negative TNBC. Kelun-Biotech CEO Dr. Michael Ge said the latest milestone follows sac-TMT’s approval for second-line or later TNBC based on Phase III OptiTROP-Breast01 data and addresses what he described as urgent demand for more effective and safer first-line options in PD-L1-negative advanced TNBC. The company describes sac-TMT as a TROP2-directed antibody-drug conjugate, or ADC (targeted cancer therapy linking an antibody to a drug), developed for advanced solid tumors. Kelun-Biotech licensed exclusive rights outside Greater China to MSD in May 2022. In China, sac-TMT has four approved indications and six Breakthrough Therapy Designations, while MSD is running 17 ongoing global Phase III studies of the drug either alone or in combinations.