By Fineline Cube 
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the completion of patient enrollment for the regulatory phase of its Phase II study of Orpathys (savolitinib) in gastric cancer with MET amplification in China. The trial has enrolled a total of 64 patients and has demonstrated promising interim results.
Study Design and Objectives
The single-arm, multi-center, open-label Phase II study evaluates the efficacy, safety, and tolerability of savolitinib in patients with gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with MET amplification. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and adverse event incidence.
Interim Results
Interim analysis revealed a 45% ORR confirmed by independent review committee (IRC) and a 50% ORR in patients with high MET gene copy numbers. The 4-month duration of response (DOR) rate was 85.7% with a median follow-up time of 5.5 months. Savolitinib was well-tolerated, with no treatment-related adverse event (TRAE) related deaths reported.
Background on Orpathys
Orpathys, an oral MET tyrosine kinase inhibitor, received conditional approval in China in June 2021 for locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations. It was the first selective MET inhibitor approved in China, developed in partnership with AstraZeneca since 2011.-Fineline Info & Tech