HUTCHMED has announced positive topline results from the Phase 3 SANOVO trial, showing that savolitinib (ORPATHYS) plus osimertinib (TAGRISSO) significantly improved progression-free survival (PFS) compared with osimertinib alone in treatment-naïve patients with EGFR-mutated, MET-overexpressing advanced non-small cell lung cancer (NSCLC) in China.
The findings move the all-oral, biomarker-directed combination into the first-line setting, following previous studies evaluating the regimen in patients whose disease had progressed after EGFR-targeted therapy.
SANOVO Meets Primary PFS Endpoint
SANOVO is a randomized, blinded Phase 3 trial evaluating savolitinib plus osimertinib versus osimertinib alone in previously untreated patients with locally advanced or metastatic NSCLC harboring activating EGFR mutations and MET overexpression.
According to HUTCHMED, the combination produced a statistically significant and clinically meaningful improvement in PFS, the study’s primary endpoint, in both the high-MET population and the intention-to-treat population.
The company also reported an encouraging benefit in overall survival (OS), a secondary endpoint, in both populations. Follow-up for survival outcomes is continuing.
Importantly, the safety profile of savolitinib plus osimertinib was consistent with the established safety profiles of the individual medicines, with no new safety signals identified.
Detailed efficacy results, including numerical PFS and OS data, have not yet been disclosed and are expected to be presented at a forthcoming medical meeting.
About the Phase 3 SANOVO Trial
The SANOVO trial enrolled 326 treatment-naïve patients in China with locally advanced or metastatic NSCLC carrying either an EGFR exon 19 deletion or L858R mutation together with MET overexpression.
Participants were randomized 1:1 to receive osimertinib plus savolitinib or osimertinib plus placebo. The primary endpoint is investigator-assessed PFS, while additional endpoints include independent-review PFS, OS, objective response rate, duration of response, disease control rate, time to response, and safety.
The study is registered as NCT05009836.
Targeting EGFR and MET From the Start
MET pathway activation can contribute to tumor progression and resistance to EGFR tyrosine kinase inhibitors in EGFR-mutated NSCLC. SANOVO was designed to investigate whether targeting both EGFR and MET at the beginning of treatment could improve outcomes in patients whose tumors already show MET overexpression.
Yi-Long Wu, Principal Investigator of SANOVO and Professor at Guangdong Provincial People’s Hospital, said the findings suggest that simultaneously targeting the two pathways may provide a new treatment strategy for this biomarker-defined patient population.
Savolitinib is an oral, selective MET tyrosine kinase inhibitor jointly developed by HUTCHMED and AstraZeneca, with AstraZeneca responsible for its commercialization.
Building on SACHI and SAFFRON
The SANOVO results add to evidence supporting savolitinib plus osimertinib across different stages of EGFR-mutated, MET-driven NSCLC.
In China, the combination is already approved for patients with locally advanced or metastatic EGFR-mutated NSCLC with MET amplification following progression on EGFR-TKI therapy, based on the Phase 3 SACHI trial.
In August 2026, HUTCHMED also announced that the global Phase 3 SAFFRON trial met its endpoints, with savolitinib plus osimertinib demonstrating statistically significant and clinically meaningful improvements in both PFS and OS in patients with EGFR-mutated NSCLC and MET overexpression or amplification after progression on osimertinib.
HUTCHMED said it plans to share the SANOVO findings with regulatory authorities as it seeks to advance the combination into the first-line treatment setting in China.
Read more on OncoDaily: AstraZeneca and HUTCHMED’s Tagrisso-Orpathys Combination Improves PFS and OS in Phase III SAFFRON Trial
