Patient Enrollment Now Complete In HUTCHMED’s Phase II Registration Trial Of Savolitinib In Gastric Cancer In China

HUTCHMED has announced the completion of patient enrollment for the registration phase of its Phase II clinical trial evaluating savolitinib in individuals with gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma who exhibit MET gene amplification. This single-arm, multi-center, open-label study is designed to assess the efficacy, safety, and tolerability of savolitinib in this specific patient population. 

The primary endpoint of the trial is the objective response rate (ORR), which is being assessed by an Independent Review Committee according to RECIST 1.1 criteria. Secondary endpoints include progression-free survival (PFS) and the incidence of various adverse events. A total of 64 patients have been enrolled in this registration study. Additional information on the trial can be found on clinicaltrials.gov under the identifier NCT04923932.

Earlier interim results from this study, presented at the American Association for Cancer Research Annual Meeting, indicated promising outcomes. A confirmed ORR of 45% was observed by the Independent Review Committee, with an even higher response rate of 50% in patients whose tumors had a high MET gene copy number. The four-month duration of response rate was reported at 85.7%, based on a median follow-up period of 5.5 months. 

In terms of safety, the most frequently observed grade 3 or higher treatment-related adverse events occurring in 5% or more of patients included decreased platelet count, hypersensitivity reactions, anemia, neutropenia, and abnormal liver function. Treatment discontinuation occurred in only one patient due to a grade 4 liver function abnormality, and there were no deaths related to treatment.

Savolitinib has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have previously undergone at least two lines of standard therapy. Based on the outcomes of this study, HUTCHMED may proceed with plans to seek marketing authorization for savolitinib in China as early as late 2025.