Sichuan Kelun Pharmaceutical Co., Ltd’s innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has announced that its Phase III clinical study for SKB264 (MK-2870) has reached its primary endpoint. The study, which is a randomized, controlled, open, multi-center trial, evaluated SKB264 in patients with irresectable local advanced, recurrent, or metastatic triple negative breast cancer (TNBC) who had received prior second-line or above standard treatment. The Independent Review Committee (IRC) assessed a statistically significant improvement in progression-free survival (PFS) compared to the control group.
SKB264: An Antibody-Drug Conjugate Targeting TROP2
SKB264 is an antibody-drug conjugate (ADC) that targets trophoblast cell-surface antigen 2 (TROP2), a protein overexpressed in various solid tumors. The drug is under development for the treatment of TNBC, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, and other advanced solid tumors. Its potential in treating locally advanced or metastatic breast cancer has earned it breakthrough therapy designation (BTD) status in China.
Global Partnership and Future Regulatory Plans
In May 2022, Sichuan Kelun-Biotech granted MSD the rights for the development and commercialization of SKB264 outside of Greater China. Following the successful interim analysis results from the Phase III study, Kelun-Biotech plans to engage in discussions with the Center for Drug Evaluation (CDE) regarding the New Drug Application (NDA) for the drug, signaling a significant step towards potential market approval and availability for patients.-Fineline Info & Tech
