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.
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines