HUTCHMED Completes Phase II Savolitinib Study Enrollment for Gastric Cancer in China

HONG KONG and FLORHAM PARK, N.J., April 22, 2025 – HUTCHMED (China) Limited has completed the patient enrollment phase for its Phase II trial of savolitinib targeting gastric cancer patients with MET amplification. This trial is designed as a single-arm, multi-center study, open-label in nature, aimed at evaluating the effectiveness, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with MET amplification. The primary measure of success is the objective response rate (ORR) as evaluated by an Independent Review Committee (IRC). Secondary objectives include measuring progression-free survival (PFS) and monitoring various adverse events.

The study has enrolled 64 patients, and detailed information can be accessed on clinicaltrials.gov with the identifier NCT04923932. Interim results shared at the American Association for Cancer Research Annual Meeting indicated a 45% ORR as confirmed by the IRC, with a notable 50% ORR in patients exhibiting a high MET gene copy number. The duration of response rate over four months was 85.7%, with the median follow-up period being 5.5 months. Common severe treatment-related adverse events (TRAE) included decreased platelet count, hypersensitivity, anemia, neutropenia, and liver function abnormalities. Only one patient discontinued due to grade 4 liver function issues, with no deaths attributed to TRAE.

The National Medical Products Administration (NMPA) of China has recognized savolitinib with Breakthrough Therapy Designation for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma with MET amplification in patients who have failed at least two prior treatment regimens. If the trial results are favorable, HUTCHMED plans to seek marketing authorization for savolitinib in China by the end of 2025.

Gastric cancer driven by MET amplification is noted for its poor prognosis, and it is estimated to affect 4-6% of gastric cancer patients. In China, around 18,000 new cases of MET-amplified gastric cancer are estimated annually. The current registration trial builds upon several Phase II studies conducted in Asia, such as the VIKTORY study, which reported a 50% ORR in patients with MET amplification treated with savolitinib alone.

Savolitinib is a selective and potent MET tyrosine kinase inhibitor developed collaboratively by AstraZeneca and HUTCHMED, with AstraZeneca handling its commercialization. It works by inhibiting atypical MET receptor tyrosine kinase activation caused by mutations, gene amplification, or protein overexpression. In China, savolitinib is marketed under the brand name ORPATHYS® for treating advanced non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations. It was the first selective MET inhibitor approved in China and has been included in the National Reimbursement Drug List since March 2023. Savolitinib is currently undergoing clinical trials for various tumor types, including lung, kidney, and gastric cancers, both as a monotherapy and in combination with other treatments.

HUTCHMED is a biopharmaceutical company focused on developing and commercializing targeted therapies and immunotherapies for cancer and immunological conditions. The company has successfully brought several drug candidates from its research pipeline to the market, with its pioneering medicine now approved globally, including in the US, Europe, and Japan.