Key Takeaways:
HUTCHMED won conditional NMPA approval for ORPATHYS in MET-amplified gastric cancer, with a 32.3% response rate in a pivotal Phase II trial.
"The clinical data provided compelling evidence that identifying MET amplification through timely molecular testing can directly guide patients to a highly effective, targeted oral option," Professor Lin Shen of Peking University Cancer Hospital and lead investigator of the registration study, said.
The approval covers locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. The Phase II study (NCT04923932), published in Nature Medicine and presented at ASCO, met its primary endpoint with an independent review committee-assessed objective response rate of 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included a disease control rate of 63.1%, median time to response of 1.4 months, median duration of response of 9.7 months (95%CI: 3.7, 18.5), and median progression-free survival of 4.0 months (95%CI: 2.6, 5.0).
MET amplification accounts for approximately 4% to 6% of gastric cancer patients, with an estimated annual incidence of about 18,000 cases in China, where gastric cancer remains one of the most common cancers and leading causes of cancer death. ORPATHYS (savolitinib) is an oral, potent, and highly selective MET tyrosine kinase inhibitor jointly developed by HUTCHMED and AstraZeneca and commercialized by AstraZeneca. This marks the third approved indication for ORPATHYS in China, following its initial approval in lung cancer, and it has been included in the National Reimbursement Drug List since March 2023.
"The approval of ORPATHYS for MET-amplified advanced gastric cancer is an important achievement that underscores HUTCHMED's enduring commitment to bringing in-house discovered innovations to patients," Johnny Cheng, acting chief executive officer and chief financial officer of HUTCHMED, said. Mary Guan, general manager of AstraZeneca China Oncology Business, said the approval "reinforces our shared vision of pairing the right treatments with the right patients through precision medicine."
HUTCHMED shares rose 4.9% on the Hong Kong Stock Exchange on the announcement. The approval gives clinicians a biomarker-driven oral option for a patient population with very poor prognosis, where no targeted therapy was previously approved in China. Investors will watch for commercial uptake data and potential expansion into additional tumor types where ORPATHYS is under clinical development.
This article is for informational purposes only and does not constitute investment advice.
