HUTCHMED Completes Patient Enrollment of a Phase II Registration Study of Savolitinib in Gastric Cancer in China

Core Viewpoint - HUTCHMED has completed enrollment for the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification, indicating progress in developing targeted therapies for this patient population [1][4]. Group 1: Clinical Trial Details - The Phase II trial is a single-arm, multi-center, open-label study aimed at evaluating the efficacy, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification, with a total of 64 patients enrolled [2]. - The primary endpoint is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC), while secondary endpoints include progression-free survival (PFS) and the incidence of various adverse events [2]. Group 2: Interim Results - Interim results from the study reported a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number, with an 85.7% duration of response (DOR) rate over a median follow-up of 5.5 months [3]. - The most common grade 3 or higher treatment-related adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities, with only one patient discontinuing treatment due to a grade 4 liver function abnormality [3]. Group 3: Regulatory Designation and Market Potential - The National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation to savolitinib for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies [4]. - If the trial results are positive, HUTCHMED may apply for marketing authorization for savolitinib in China by late 2025, highlighting the potential market opportunity for this treatment [4][5]. Group 4: Background on Gastric Cancer and Savolitinib - MET-driven gastric cancer has a poor prognosis, with MET amplification accounting for approximately 4-6% of gastric cancer patients, translating to an estimated annual incidence of about 18,000 cases in China [5]. - Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, currently approved in China for treating non-small cell lung cancer with MET exon 14 skipping alteration [6][7].