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HONG KONG - Hutchmed (Nasdaq/AIM:HCM; HKEX:13) announced Wednesday it has completed patient enrollment in its SANOVO Phase III trial evaluating ORPATHYS (savolitinib) in combination with TAGRISSO (osimertinib) as a first-line treatment for certain non-small cell lung cancer patients.
The study focuses on patients with locally advanced or metastatic NSCLC whose tumors harbor both EGFR mutations and MET overexpression. The last patient was enrolled on Monday, according to the company’s press release.
The randomized, blinded trial will compare the efficacy and safety of the ORPATHYS-TAGRISSO combination against TAGRISSO alone, which is currently a standard treatment for these patients. Progression-free survival as assessed by investigators is the primary endpoint.
Topline results from the SANOVO study are expected in the second half of 2026. If favorable, the company plans to submit a supplementary New Drug Application to China’s National Medical (TASE:BLWV) Products Administration.
ORPATHYS is an oral MET tyrosine kinase inhibitor jointly developed by AstraZeneca (NASDAQ:AZN) and Hutchmed, while TAGRISSO is a third-generation EGFR tyrosine kinase inhibitor.
The drug combination has already received approval in China for treating patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, based on results from the SACHI Phase III study presented in June.
In the United States, the combination received Fast Track Designation from the FDA in 2023 for a similar indication. A separate global Phase III trial called SAFFRON is currently ongoing.
Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for 80-85% of cases. Between 10-50% of NSCLC patients have EGFR mutations, with rates varying by region.
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