NEW YORK – Hutchmed and AstraZeneca on Wednesday said they've launched a Phase II study of their MET inhibitor Orpathys (savolitinib) in patients with metastatic MET-amplified gastric cancer or adenocarcinoma of the gastroesophageal junction.
In the Phase II trial, the first patient this week received savolitinib, which AstraZeneca and Hutchmed are codeveloping and commercializing under a 2011 global licensing agreement. The trial will enroll locally advanced or metastatic gastric cancer or gastroesophageal cancer patients who have progressed on at least one line of standard therapy. Patients also must have MET-amplified tumors.
The primary endpoint is objective response rate as evaluated by an independent review committee. Researchers, led by Beijing Cancer Hospital, are also interested in patients' 12-week and six-month progression-free survival rates, median progression-free survival, duration of response, disease control rate, median overall survival, safety, pharmacokinetics, and quality of life on the drug.
Hutchmed and AstraZeneca are launching this Phase II trial after seeing data from the South Korean Phase II VIKTORY umbrella trial, in which 10 out of 20 MET-amplified gastric cancer patients responded to savolitinib. The companies estimated that between 4 percent and 6 percent of gastric cancer patients have MET-amplified tumors. In China, there are around 24,000 new gastric cancer cases each year.
In June, China's National Medical Products Administration granted conditional approval to savolitinib as a treatment for non-small cell lung cancer patients who have progressed on systemic therapy, are unable to receive chemotherapy, and have MET exon 14 skipping alterations in their tumors.