HUTCHMED (00013) announced that patient enrollment has been completed for the SANOVO China Phase III study evaluating the combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as first-line treatment for specific non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations and MET overexpression. The last patient was enrolled on August 18, 2025.

This Phase III study is a blinded, randomized controlled clinical trial conducted in treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR activating mutations and MET overexpression. The study will evaluate the efficacy and safety of the TAGRISSO® and ORPATHYS® combination therapy compared to TAGRISSO® monotherapy, which is the current standard of care for such patients.

The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include independent review committee-assessed PFS, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety.

Topline results from the SANOVO study are expected to be announced in the second half of 2026, with subsequent submission for presentation at appropriate academic conferences. If favorable results are achieved, HUTCHMED plans to initiate the submission of a new indication marketing application to China's National Medical Products Administration (NMPA).

ORPATHYS® is a potent and highly selective oral MET tyrosine kinase inhibitor (TKI) co-developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca. TAGRISSO® is an irreversible third-generation EGFR TKI.