Kelun-Biotech recently held an Independent Data Monitoring Committee (IDMC) meeting to review the interim analysis data of the Phase III clinical trial of SKB264. The IDMC resolution indicated that the trial met the primary endpoint of progression-free survival (PFS) as assessed by the Independent Review Committee (IRC), and at a pre-specified interim analysis, SKB264 demonstrated a statistically significant improvement in PFS, compared with the control group receiving standardized chemotherapy. Based on the results from the interim analysis, Kelun-Biotech plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China regarding the submission of a new drug application (NDA) of SKB264.

Dr. Ge Junyou, Executive Director and General Manager of Kelun-Biotech, commented, "TNBC is one of the most aggressive and prevalent subtypes of breast cancer (BC) with huge unmet medical needs. Patients with TNBC who have received second-line or later treatment have an overall survival of 5.2 to 8.4 months ^[1]. SKB264 has been granted breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic TNBC. For drugs included in the list of BTD, the CDE will prioritize resource allocation for communication and guidance to facilitate drug development. This will help accelerate the development and commercialization of SKB264 to provide high-quality treatment options for patients with advanced TNBC."

SKB264 is one of the core products with independent intellectual property rights of Kelun-Biotech, and will be supported by an extensive development plan. This clinical trial, which met its primary endpoint, is the first registrational Phase III study of SKB264 (MK-2870) in China. In addition, Kelun-Biotech is also advancing a Phase II trial of SKB264 with or without KL-A167 (Kelun's anti-PD-L1 monoclonal antibody) as a first-line treatment for advanced TNBC, and another randomized, open-label, multicenter Phase III clinical study of SKB264 versus investigator's choice regimens in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who had failed at least one line of chemotherapy is expect to be launched in the second half of 2023.