- HUTCHMED has completed patient enrollment for its Phase II trial of savolitinib in gastric cancer.
- Interim results show a 45% objective response rate with a promising safety profile.
- Savolitinib received Breakthrough Therapy Designation from China's NMPA.
HUTCHMED (HCM, Financial) has successfully completed the patient enrollment phase for its Phase II registration trial evaluating the efficacy of savolitinib in treating patients with gastric cancer who exhibit MET amplification. A total of 64 patients have been enrolled in this single-arm, multi-center study focused on gastric or gastroesophageal junction adenocarcinoma.
Interim results from the trial have shown encouraging outcomes, with a 45% objective response rate (ORR) confirmed by an Independent Review Committee. Notably, patients with a high MET gene copy number demonstrated an even higher ORR of 50%. These results come as a positive development for a patient group that typically has limited treatment options.
The interim data also revealed an 85.7% 4-month duration of response rate with a median follow-up period of 5.5 months. The safety profile of savolitinib appears manageable, with only a single treatment discontinuation due to a grade 4 liver function abnormality. Other common adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities.
The promising interim results have led to the granting of the Breakthrough Therapy Designation by China's National Medical Products Administration (NMPA) for savolitinib. This designation could facilitate an accelerated development and review process. HUTCHMED plans to seek marketing authorization in China by late 2025, pending continued positive trial outcomes.
