Clinical TrialMay 22, 2026, 06:12 AM
HUTCHMED Savolitinib Phase II Met Primary Endpoint in Gastric Cancer
AI Summary
HUTCHMED announced that new and updated clinical data from several of its compounds will be presented at the 2026 ASCO Annual Meeting. The pivotal Phase II registration study of savolitinib in gastric cancer met its primary endpoint, showing an objective response rate of 32.3%. These positive results supported the New Drug Application submission to China's NMPA, which was accepted and granted priority review in December 2025. Additionally, further analyses of fruquintinib and surufatinib studies across various tumor indications will be highlighted.
Key Highlights
- Savolitinib pivotal Phase II study met primary endpoint of objective response rate (ORR) in gastric cancer.
- Savolitinib's IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified threshold.
- Savolitinib achieved a disease control rate (DCR) of 63.1% and median duration of response (DoR) of 9.7 months.
- Savolitinib showed a median progression-free survival (PFS) of 4.0 months.
- New Drug Application (NDA) for savolitinib was accepted and granted priority review by China NMPA in December 2025.
- Further analyses of fruquintinib's FRESCO, FRESCO-2, FRUSICA-1, and FRUSICA-2 studies will be presented.
- Investigator-initiated studies of fruquintinib and surufatinib across various tumor indications will also be presented.
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