Sichuan Kelun-Biotech Biopharmaceutical (Kelun-Biotech) has reported that the Phase III clinical trial evaluating SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who have failed second-line or above prior standard of care has met the primary endpoint.
An Independent Data Monitoring Committee (IDMC) meeting was held for reviewing the interim analysis data of the SKB264 Phase III study.
As assessed by the Independent Review Committee (IRC), and at a pre-specified interim analysis, the IDMC resolution indicated that the study met the primary endpoint of progression-free survival (PFS).
The controlled, multi-centre, open-label, randomised study compared SKB264 for injection against investigator selected regimens.
A statistically significant improvement in PFS was observed in SKB264 group against control group receiving standardised chemotherapy.
Based on the results from the interim analysis, the company anticipates submitting a new drug application for SKB264 to the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China.
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Kelun-Biotech executive director and general manager Dr Ge Junyou said: “Patients with TNBC who have received second-line or later treatment have an overall survival of 5.2 to 8.4 months.
“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 prioritise resource allocation for communication and guidance to facilitate drug development.
“This will help accelerate the development and commercialisation 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.
The company is evaluating SKB264 with or without Kelun’s anti-PD-L1 monoclonal antibody KL-A167 in a Phase II study, as a first-line treatment for advanced TNBC.
SKB264, also known as MK-2870, is an TROP2-directed ADC developed by Kelun-Biotech’s international ADC R&D platform OptiDC using a proprietary payload-linker strategy.