Savolitinib (Orpathys) plus osimertinib (Tagrisso) produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with osimertinib alone in treatment-naive patients with EGFR-mutated, MET-overexpressing,
Overall survival (OS), a secondary end point, trended toward improvement with the combination in both populations, according to the release.1 Follow-up for OS is ongoing, and the full data set will be presented at a forthcoming medical meeting, according to a news release from HUTCHMED.1
Co-occurring MET overexpression in treatment-naïve EGFR-mutated NSCLC often compromises the long-term durability of EGFR-TKI monotherapy. The positive findings from SANOVO demonstrate that addressing both pathways upfront with an all-oral, biomarker-directed regimen offers a powerful new approach for these patients whose tumors have MET overexpression.
Yi-Long Wu, a professor at Guangdong Provincial People's Hospital in Guangzhou, China, and the trial's lead principal investigator, said in the news release.1
SANOVO is a blinded, randomized, controlled phase 3 study conducted in China in treatment-naive patients with locally advanced or metastatic NSCLC harboring activating EGFR mutations (exon 19 deletion or L858R) and MET overexpression.1,2 A total of 326 patients were randomly assigned 1:1 to receive osimertinib at 80 mg once daily plus either savolitinib or placebo at 300 mg or 200 mg twice daily, dosed according to body weight.1
The primary end point is investigator-assessed PFS; other end points include PFS per independent review committee, OS, objective response rate, duration of response, disease control rate, time to response, and safety.
MET overexpression or amplification can drive tumor growth and metastatic progression and is a recognized mechanism of resistance to EGFR tyrosine kinase inhibitor (TKI) monotherapy in EGFR-mutated NSCLC. Savolitinib plus osimertinib is already approved in China for patients with EGFR-mutated NSCLC and MET amplification following disease progression on an EGFR TKI, based on the phase 3 SACHI trial (NCT05015608).
The combination also produced a statistically significant improvement in PFS and OS compared with platinum-based chemotherapy in the global phase 3 SAFFRON trial (NCT05261399) among patients with MET-overexpressing or MET-amplified, osimertinib-resistant, EGFR-mutated NSCLC, according to topline results reported in August 2026.3 SANOVO extends this combination strategy into the treatment-naive, first-line setting.1
The safety profile of savolitinib plus osimertinib in SANOVO was consistent with the known safety profiles of each agent, and no new safety findings were reported. HUTCHMED said it plans to share the SANOVO data with Chinese regulatory authorities to support use of the combination in the first-line setting.
