HUTCHMED Completes Patient Enrollment In SANOVO Phase III Trial Of ORPATHYS® & TAGRISSO® Combination As First-Line Therapy For Lung Cancer In China

HUTCHMED (China) Limited announced the completion of patient enrollment in SANOVO, a China Phase III clinical trial evaluating ORPATHYS® (savolitinib) in combination with TAGRISSO® (osimertinib) as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors carry epidermal growth factor receptor (EGFR) mutations and MET overexpression. The final patient was enrolled on August 18, 2025.

The SANOVO study is a randomized, blinded, controlled trial designed to compare the efficacy and safety of the combination of ORPATHYS® and TAGRISSO® against TAGRISSO® monotherapy, which is currently a standard-of-care option for this patient group. The primary endpoint is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS as assessed by an independent review committee, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. Further trial information is available on clinicaltrials.gov under identifier NCT05009836.

Topline results from the SANOVO trial are expected in the second half of 2026. Pending favorable outcomes, HUTCHMED and AstraZeneca plan to submit the findings for presentation at a major medical congress and pursue a supplementary New Drug Application with China’s National Medical Products Administration (NMPA). ORPATHYS® is an oral, highly selective, and potent MET tyrosine kinase inhibitor (TKI) jointly developed by HUTCHMED and AstraZeneca, and commercialized by AstraZeneca. TAGRISSO® is a third-generation, irreversible EGFR TKI widely used in the treatment of EGFR-mutated NSCLC.