NMPA accepts NDA for KN026 in patients with HER2+ve locally advanced, recurrent, or metastatic gastric or GEJ cancer
This NDA for KN026 is primarily based on a pivotal Phase II/III clinical trial (Study ID: KN026-001). Results from the first interim analysis of the Phase III clinical study demonstrated that, compared to the current standard of care, KN026 combined with chemotherapy significantly improved clinical efficacy, by prolonging progression-free survival (PFS) and overall survival (OS). Furthermore, the combination showed no new safety signals, with a low incidence of cardiotoxicity and low immunogenicity in terms of safety profile. Previously, results from the Phase II clinical study, presented at the 2024 European Society for Medical Oncology (ESMO) Congress, showed that KN026 in combination with chemotherapy achieved an objective response rate (ORR) of 40.0%, with a median PFS of 8.6 months as assessed by the independent review committee (IRC). KN026 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA on November 4, 2023, and received Priority Review status on August 28, 2025.
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