HUTCHMED has completed enrollment for the registration phase of its Phase II savolitinib trial in gastric cancer patients with MET amplification. The trial, which enrolled 64 patients, assesses savolitinib’s efficacy, safety, and tolerability in treating gastric or gastroesophageal junction adenocarcinoma with MET amplification, using objective response rate as the primary endpoint. Interim results show a promising 45% objective response rate confirmed by an Independent Review Committee and a 50% ORR in patients with high MET gene copy number.
This completion marks a crucial step toward potential marketing authorization in China, addressing a cancer subtype with limited treatment options and a poor prognosis. Gastric cancer with MET amplification represents a significant unmet need, with an estimated annual incidence of 18,000 in China alone. The positive interim data, including a high objective response rate and manageable safety profile, suggest that savolitinib could become a valuable therapeutic option for these patients.
The Phase II trial involves a single-arm, multi-center, open-label design. Interim analysis demonstrated a 4-month duration of response rate of 85.7% with a median follow-up of 5.5 months. Observed adverse events were generally manageable, with the most common grade 3 or higher treatment-related events being decreased platelet count, hypersensitivity, anemia, neutropenia, and abnormal hepatic function. Importantly, only one patient discontinued treatment due to adverse events, and no treatment-related deaths occurred. China’s NMPA has granted Breakthrough Therapy Designation to savolitinib for this indication.
Positive trial results could lead to a marketing authorization application in China by late 2025, potentially offering a new treatment avenue for patients with this aggressive cancer subtype. This advancement underscores the potential of targeted therapies like savolitinib in improving outcomes for patients with genetically defined cancers and further solidifies HUTCHMED’s presence in the oncology field. The outcome of this trial will significantly impact the gastric cancer treatment landscape, particularly in China.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
