ORPATHYS (savolitinib) and TAGRISSO (osimertinib) - (SANOVO)

Aug. 31, 2026: HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) reported positive high-level results from the SANOVO China Phase III trial of ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in treatment-naïve patients with locally advanced or metastatic EGFR-mutated NSCLC with MET overexpression. The combination achieved a statistically significant, clinically meaningful improvement in progression-free survival versus TAGRISSO alone in both the high-MET and intention-to-treat populations. Overall survival, a secondary endpoint, also showed a very encouraging clinical benefit; follow-up is ongoing. Safety was consistent with the known profiles of both drugs, with no new safety findings.

SANOVO enrolled 326 patients in China and randomized them 1:1 to TAGRISSO 80 mg daily plus savolitinib or placebo; the primary endpoint is investigator-assessed PFS (ClinicalTrials.gov: NCT05009836). HUTCHMED said the data will be presented at a forthcoming medical meeting and shared with regulatory authorities to support potential first-line use in China.

Context from the release: ORPATHYS plus TAGRISSO is already approved in China for EGFR-mutated NSCLC with MET amplification after progression on EGFR-TKI therapy based on SACHI, and the global Phase III SAFFRON study in post-TAGRISSO EGFR-mutated NSCLC with MET overexpression or amplification also reported positive high-level PFS and OS results in August 2026.