Kelun Biotech seeks marketing approval on sac-TMT for the first-line treatment of PD-L1-negative TNBC
On July 30, 2026, Sichuan Kelun Biotech Co., Ltd. (“Kelun”) announced that its independently developed antibody-drug conjugate (ADC) targeting human trophoblast surface antigen 2 (TROP2), sac-TMT (also known as SKB264/MK-2870) (Gitalay®), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC) with a programmed cell death ligand 1 (PD-L1) composite positive score (CPS) <10 or who have received programmed cell death protein-1 (PD-1)/PD-L1 inhibitors in the early stages. This is the sixth indication application for sac-TMT to be accepted by the NMPA.
This acceptance is based on positive results from the randomized, open-label, multicenter phase III registrational OptiTROP-Breast03 study. This study aimed to evaluate the efficacy and safety of salvagen-sartuzumab (sac-TMT) versus investigator-selected chemotherapy in patients with advanced-stage, unresectable, recurrent or metastatic TNBC who had not received prior systemic therapy. The enrolled population included patients with PD-L1 CPS <10 and those who had relapsed after prior early-stage PD-1/PD-L1 inhibitor therapy. The results showed that salvagen-sartuzumab (sac-TMT) achieved statistically significant and clinically meaningful improvements in key efficacy endpoints compared to investigator-selected chemotherapy, demonstrating clear clinical benefits.
Previously, sac-TMT had been granted Breakthrough Therapy Designation (BTD) by the NMPA for first-line treatment of unresectable locally advanced, recurrent, or metastatic PD-L1-negative TNBC. This new application for a new indication has also been included in the priority review and approval process, becoming the sixth application for sac-TMT to be included in this process. Inclusion in the priority review and approval process is expected to further accelerate the review and market launch, allowing this innovative treatment to benefit patients sooner.
“Following the approval of salvagenumab (sac-TMT) for second-line and later-line TNBC based on the results of the Phase III OptiTROP-Breast01 study, we are delighted to witness another important milestone for this drug in the same disease area. For patients with advanced PD-L1-negative TNBC, the efficacy of traditional chemotherapy is limited, and there is an urgent clinical need for more effective and safer first-line treatment options. The positive results of the OptiTROP-Breast03 study showed that salvagenumab (sac-TMT) demonstrated a clear and clinically significant efficacy advantage over chemotherapy, providing strong evidence for its expansion into first-line treatment of TNBC. We look forward to the early approval and marketing of this indication, bringing new and more effective first-line treatment options to more patients with advanced TNBC,” said Dr. Junyou Ge, CEO of Kelun-Biotech.
Source: Kelun-Biotech | Top Image: Getty Images
