What's Happening?
Kelun-Biotech has announced positive results from its Phase 3 OptiTROP-Breast02 study, presented at the 2025 European Society for Medical Oncology Congress. The study evaluated sacituzumab tirumotecan
(sac-TMT), a TROP2-directed antibody-drug conjugate, in patients with hormone receptor-positive (HR+) and HER2-negative breast cancer. The trial involved 399 patients who had progressed on CDK4/6 inhibitors and received prior chemotherapy. Sac-TMT demonstrated a median progression-free survival (PFS) of 8.3 months compared to 4.1 months for the investigator's choice of chemotherapy. The study showed clinical benefits independent of HER2 expression and a trend towards improved overall survival. Sac-TMT also exhibited a favorable safety profile, with manageable adverse events. The company is conducting further Phase III trials globally and in China to explore sac-TMT's efficacy in combination with pembrolizumab.
Why It's Important?
The positive results from the OptiTROP-Breast02 study highlight sacituzumab tirumotecan's potential as a new treatment option for HR+/HER2- breast cancer, addressing a significant unmet need in oncology. The findings could lead to improved patient outcomes and expand treatment options for breast cancer patients globally. Kelun-Biotech's advancements in antibody-drug conjugates (ADCs) reinforce its position in the biopharmaceutical industry, potentially influencing future drug development and commercialization strategies. The study's success may also drive further research collaborations and investments in innovative cancer therapies.
What's Next?
Kelun-Biotech plans to continue its Phase III clinical trials of sacituzumab tirumotecan, both as a monotherapy and in combination with pembrolizumab, targeting chemotherapy-naïve HR+/HER2- breast cancer patients. These trials aim to enroll approximately 1,200 participants globally and 430 in China. The company is also pursuing new indication applications for sac-TMT, which have been accepted for priority review by the National Medical Products Administration. The ongoing research and regulatory processes will determine sac-TMT's future market presence and its role in breast cancer treatment.
