Kelun-Biotech Reports Positive Phase 3 Results for Sacituzumab Tirumotecan in Advanced HR+/HER2- Breast Cancer
Reuters
Oct 18
Kelun-Biotech Reports Positive Phase 3 Results for Sacituzumab Tirumotecan in Advanced HR+/HER2- Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced positive results from the Phase 3 OptiTROP-Breast02 clinical study evaluating sacituzumab tirumotecan (sac-TMT), a TROP2-directed antibody-drug conjugate, in patients with previously treated locally advanced or metastatic hormone receptor-positive (HR+)/HER2-negative breast cancer. The results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany. The study demonstrated that sac-TMT achieved statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy, with benefits observed across all predefined subgroups and independent of HER2 status. Sac-TMT also showed a trend toward overall survival benefit and had a favorable and manageable safety profile with no new safety signals reported. Additional Phase III clinical studies of sac-TMT as monotherapy and in combination with pembrolizumab are ongoing globally and in China.
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