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
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data