HONG KONG - HUTCHMED (China) Limited (Nasdaq/AIM:HCM; HKEX:13) has completed patient enrollment for its Phase II trial of savolitinib, a drug intended for the treatment of gastric cancer with MET amplification, the company announced today. The trial is a significant step in the development of savolitinib, which has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for this specific cancer type.
The study, which is open-label and multi-centered, aims to assess the efficacy, safety, and tolerability of savolitinib in patients with gastric cancer or gastroesophageal junction adenocarcinoma who exhibit MET amplification—a genetic alteration associated with poor prognosis in cancer. With 64 patients enrolled, the primary measure of the drug’s success will be the objective response rate (ORR), as evaluated by an Independent Review Committee (IRC) using RECIST 1.1 criteria.
Interim results presented at the American Association for Cancer Research Annual Meeting showed an ORR of 45% confirmed by IRC and a 50% ORR in patients with high MET gene copy number. The study also reported a 4-month duration of response rate of 85.7%, with a median follow-up time of 5.5 months. Most common severe treatment-related adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and abnormal liver function, with only one patient discontinuing due to a grade 4 liver function abnormality. No deaths related to treatment were reported.
Savolitinib, which is being developed by HUTCHMED and AstraZeneca (NASDAQ:AZN), is already approved in China for a specific type of non-small cell lung cancer and has been included in the National Reimbursement Drug List of China since March 2023. It is also under clinical development for several other tumor types, including lung, kidney, and gastric cancers, both as a single treatment and in combination with other medications.
If the ongoing study yields positive results, HUTCHMED plans to apply for marketing authorization in China for savolitinib as a treatment for gastric cancer by late 2025. The annual incidence of MET amplification gastric cancer in China is estimated to be approximately 18,000 cases.
This news article is based on a press release statement from HUTCHMED.
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