Core Viewpoint - The approval of the antibody-drug conjugate sac-TMT (also known as SKB264/MK-2870) for a new indication in treating HR+/HER2- breast cancer patients in China marks a significant milestone for the company, expanding its therapeutic applications in the oncology space [1] Group 1: Regulatory Approval - The National Medical Products Administration (NMPA) of China has approved sac-TMT for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously received endocrine therapy and at least one line of chemotherapy [1] - This approval represents the fourth indication for sac-TMT in China [1] Group 2: Clinical Study Results - The approval is based on positive results from the OptiTROP-Breast023 phase II clinical study, which was presented at the 2025 European Society for Medical Oncology (ESMO) conference [1] - The OptiTROP-Breast02 study demonstrated that sac-TMT significantly improved progression-free survival (PFS) compared to chemotherapy, with a PFS of 8.3 months versus 4.1 months (hazard ratio (HR) of 0.35; 95% confidence interval (CI): 0.26-0.48; p<0.0001) [2] - Consistent PFS benefits were observed across various subgroups, including those with different HER2 expression levels and prior chemotherapy lines [2] - The overall survival (OS) trend and objective response rate (ORR) were also notably improved in the sac-TMT group, with an ORR of 41.5% compared to 24.1% in the chemotherapy group [2] Group 3: Ongoing Research - Ongoing phase III clinical studies are evaluating sac-TMT, both alone and in combination with pembrolizumab, for HR+/HER2- breast cancer patients who have previously received endocrine therapy but not chemotherapy [3]
科伦博泰生物-B(06990)：核心产品TROP2ADC芦康沙妥珠单抗(sac-TMT)获国家药品监督管理局批准第四项适应症上市，用于治疗2L+HR+/...