What's Happening?
Kelun-Biotech has announced that its TROP2-directed antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT), has received approval from the National Medical Products Administration (NMPA) of China for a new indication. This approval is for the treatment
of adult patients with unresectable or metastatic HR+/HER2- breast cancer who have previously undergone endocrine therapy and at least one line of chemotherapy. The approval is based on positive results from the Phase III OptiTROP-Breast02 study, which demonstrated a significant increase in progression-free survival compared to chemotherapy. Sac-TMT is now approved for four indications in China, including treatments for non-small cell lung cancer and triple-negative breast cancer.
Why It's Important?
The approval of sacituzumab tirumotecan for HR+/HER2- breast cancer is significant as it offers a new treatment option for patients with limited alternatives. This subtype of breast cancer, which accounts for about 70% of all cases, often has a poor prognosis once it progresses beyond endocrine therapy. The approval could potentially improve outcomes for patients by providing a more effective treatment option compared to traditional chemotherapy. Additionally, the inclusion of sac-TMT in China's National Reimbursement Drug List for certain indications may increase accessibility and affordability for patients, potentially improving survival rates and quality of life.
What's Next?
Kelun-Biotech is continuing to expand the clinical applications of sac-TMT, with ongoing Phase III studies globally and in China. These studies are exploring the use of sac-TMT in combination with pembrolizumab for chemotherapy-naïve HR+/HER2- breast cancer patients. The company is also conducting multiple registrational clinical studies in China and globally, sponsored by Merck & Co., Inc., to evaluate sac-TMT for various cancer types. The outcomes of these studies could lead to further approvals and expanded use of sac-TMT in oncology treatment protocols.
