HUTCHMED Savolitinib Phase II ORR 32.3% in gastric cancer; NDA accepted
HUTCHMED (China) Limited announced that new and updated data from several studies of its compounds will be presented at the ASCO Annual Meeting from May 29 to June 2, 2026. Key among these are results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China. The study met its primary endpoint with an objective response rate (ORR) of 32.3%, supporting the New Drug Application (NDA) submission to the China NMPA, which was accepted and granted priority review. Additionally, further analyses of fruquintinib's FRESCO, FRESCO-2, FRUSICA-1, and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib, will be presented.
Key Highlights
- Pivotal Phase II study of savolitinib in MET-amplified gastric cancer met its primary endpoint of objective response rate (ORR).
- IRC-assessed ORR for savolitinib was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold.
- Secondary endpoints for savolitinib included DCR of 63.1%, median TTR of 1.4 months, and median DoR of 9.7 months.
- Median progression-free survival (PFS) for savolitinib was 4.0 months.
- The data supported the New Drug Application (NDA) submission to China NMPA, accepted and granted priority review in December 2025.
- New and updated data from fruquintinib and surufatinib studies will also be presented at ASCO 2026.
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