Core Viewpoint - The announcement by Hutchison China MediTech regarding the completion of patient enrollment for the Phase II study of Savolitinib in treating MET-amplified gastric cancer highlights significant progress in the development of targeted therapies for this patient population [1][2]. Group 1: Clinical Trial Details - The Phase II study is a single-arm, multi-center, open-label trial aimed at evaluating the efficacy, safety, and tolerability of Savolitinib in patients with MET-amplified gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma [1]. - The study enrolled a total of 64 patients, with the primary endpoint being the objective response rate (ORR) assessed by an independent review committee (IRC) [1]. - Interim analysis presented at the American Association for Cancer Research (AACR) annual meeting showed an ORR of 45%, increasing to 50% in patients with high MET gene copy numbers [1]. Group 2: Safety and Efficacy Results - The duration of response at four months was reported at 85.7%, with a median follow-up time of 5.5 months [1]. - The most common treatment-related adverse events (TRAE) of grade 3 or higher (occurring in over 5% of patients) included thrombocytopenia, hypersensitivity, anemia, neutropenia, and liver function abnormalities [1]. - Only one patient discontinued treatment due to grade 4 liver function abnormalities, and there were no treatment-related deaths reported [1]. Group 3: Regulatory and Market Potential - The National Medical Products Administration (NMPA) of China has included Savolitinib in the list of breakthrough therapy drugs for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma in patients who have failed at least two lines of standard therapy [2]. - If the study yields positive results, Hutchison China MediTech is expected to submit a marketing authorization application to the NMPA by the end of 2025 [2]. - Approximately 4-6% of gastric cancer patients are estimated to have MET amplification, with around 18,000 new cases reported annually in China [2]. Group 4: Product Background - Savolitinib is a potent and selective oral MET tyrosine kinase inhibitor (TKI) co-developed by AstraZeneca and Hutchison China MediTech, with AstraZeneca responsible for commercialization [2]. - The drug has already been approved in China for treating locally advanced or metastatic non-small cell lung cancer in patients with MET exon 14 mutations and has been included in the national medical insurance drug list since March 2023 [3]. - Savolitinib is also being developed for various tumor types, including lung cancer, kidney cancer, and gastric cancer, either as monotherapy or in combination with other drugs [3].
和黄医药(00013)：赛沃替尼用于治疗MET扩增胃癌患者的II期研究的注册阶段已完成患者入组