HUTCHMED's Savolitinib Hits Primary Endpoint in Gastric Cancer Trial…

Event summary

HUTCHMED's savolitinib met primary endpoint in Phase II gastric cancer trial, with an ORR of 32.3%.
The study's data cut-off was October 8, 2025, and results will be presented at ASCO 2026.
Secondary endpoints included a DCR of 63.1%, median PFS of 4.0 months, and median DoR of 9.7 months.
The NDA for savolitinib was accepted by NMPA in December 2025 and granted priority review.
Additional data on fruquintinib and surufatinib across various tumor indications will also be presented.

The big picture

HUTCHMED's positive Phase II data for savolitinib positions it as a potential new treatment option for gastric cancer, a market with significant unmet needs. The company's focus on developing targeted therapies and immunotherapies aligns with the broader trend in oncology towards precision medicine. The acceptance of the NDA by NMPA and the priority review status indicate strong regulatory support, which could accelerate the drug's market entry.

What we're watching

Regulatory Pathway: Whether the NMPA's priority review will lead to expedited approval for savolitinib in China.
Clinical Efficacy: How the ORR and other secondary endpoints of savolitinib compare to existing treatments for gastric cancer.
Market Expansion: The pace at which HUTCHMED can expand the use of fruquintinib and surufatinib into new tumor indications.