HUTCHMED and AstraZeneca Begin Phase II Trial of ORPATHYS® in Gastric Cancer

HUTCHMED and AstraZeneca PLC have initiated a Phase II study of ORPATHYS® (savolitinib), an oral, potent, and highly selective small-molecule inhibitor of MET, a receptor tyrosine kinase, in patients with advanced or metastatic MET amplified gastric cancer (“GC”) or adenocarcinoma of the gastroesophageal junction (“GEJ”). The first patient was dosed on July 27, 2021.

The Phase II trial is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (“PK”) of ORPATHYS® in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy. The primary endpoint is objective response rate (“ORR”) as assessed by an independent review committee. Other endpoints include 12-week and 6-month progression-free survival (“PFS”) rates, median PFS, duration of response (“DoR”), disease control rate (“DCR”), median overall survival (“OS”), safety, PK and quality of life.

The Beijing Cancer Hospital is the lead institution of this study. The lead investigator is Dr Shen Lin. For more information, please see clinicaltrials.gov identifier: NCT04923932.

MET-driven gastric cancer has a very poor prognosis. This trial follows multiple Phase II studies that have been conducted in Asia to study ORPATHYS® in MET-driven gastric cancer patients, including VIKTORY. VIKTORY is an investigator-initiated Phase II umbrella study in gastric cancer in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified gastric cancer. Patients whose tumors harbor MET amplification were treated with ORPATHYS® monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

It is estimated that MET amplification accounts for approximately 4-6% of GC patients. The annual incidence of MET amplification GC is estimated to be approximately 24,000 in China.