HUTCHMED (00013.HK): Savolitinib Phase II Gastric Cancer Data Selected for ASCO Rapid Oral Presentation, Achieving an ORR of 32.3%

NewTimeSpace · 2026/05/22 08:38 · By Boyuan Chen

HUTCHMED (00013.HK) will present Phase II registration study data for savolitinib in MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma (GEA) at the 2026 ASCO Annual Meeting, demonstrating an IRC-assessed ORR of 32.3%, a DCR of 63.1%, and a median PFS of 4.0 months. The relevant NDA was accepted and granted Priority Review in December 2025. Further analysis results from multiple studies of fruquintinib and surufatinib will also be released.

HUTCHMED (China) Limited (00013.HK; Short Name: HUTCHMED) announced on May 22 that new and updated data from several studies on company-independently developed compounds will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held from May 29 to June 2, 2026, in Chicago, USA.

According to the announcement, the results from the pivotal Phase II registration study in China evaluating savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma (GEA) will be unveiled during a Rapid Oral Abstract session. The study met its primary endpoint of Objective Response Rate (ORR) as assessed by an Independent Review Committee (IRC) using RECIST 1.1 standards. As of the data cutoff date on October 8, 2025, the IRC-assessed ORR was 32.3% (95% $CI$: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included an IRC-assessed disease control rate (DCR) of 63.1%, a median time to response (TTR) of 1.4 months, a median duration of response (DoR) of 9.7 months (95% $CI$: 3.7, 18.5), and a median progression-free survival (PFS) of 4.0 months (95% $CI$: 2.6, 5.0). These data supported the New Drug Application (NDA) submission to the National Medical Products Administration (NMPA) of China, which was accepted and granted Priority Review in December 2025.

Additionally, further analysis results from the FRESCO, FRESCO-2, FRUSICA-1, and FRUSICA-2 studies of fruquintinib, alongside investigator-initiated trial results of fruquintinib and surufatinib across multiple potential tumor indications, will also be presented at the annual meeting.

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