Hutchmed enrols patients for phase two savolitinib trial
By Josh White
Date: Tuesday 22 Apr 2025
(Sharecast News) - Hutchmed China announced on Tuesday that it has completed patient enrollment for the registration phase of its phase two clinical trial, evaluating savolitinib in Chinese patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma.
The AIM-traded firm said the single-arm, multi-centre, open-label study enrolled 64 patients and will assess the efficacy, safety and tolerability of the selective MET inhibitor, with the primary endpoint being objective response rate as determined by independent review.
Interim results presented at the American Association for Cancer Research annual meeting showed a 45% objective response rate, increasing to 50% in patients with high MET gene copy number.
The four-month duration of response rate was 85.7%, with a median follow-up of 5.5 months.
Safety data showed that the most common grade three or higher treatment-related adverse events included thrombocytopenia, hypersensitivity, anaemia, neutropenia, and hepatic function abnormalities.
One patient discontinued due to grade four liver toxicity, with no treatment-related deaths reported.
Savolitinib has been granted breakthrough therapy designation in China for the treatment of MET-amplified gastric cancer in patients who had failed at least two prior therapies.
Subject to positive results, Hutchmed said it could file for marketing authorisation in China in late 2025.
The company said it was co-developing savolitinib with AstraZeneca, which markets the drug in China under the brand name 'Orpathys' for MET exon 14-altered non-small cell lung cancer.
At 0852 BST, shares in Hutchmed China were up 10.4% at 234.05p.
Reporting by Josh White for Sharecast.com.
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