Hong Kong, Shanghai, China, and Florham Park, New Jersey, August 31, 2026
HUTCHMED (China) Limited has announced positive high-level results from the SANOVO Phase III trial, showing that ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with TAGRISSO alone in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations and MET overexpression. The results represent an important development for biomarker-directed treatment of a patient population in which simultaneous activation of EGFR and MET pathways can contribute to disease progression. The combination also demonstrated an encouraging clinical benefit in overall survival (OS), a secondary endpoint, although follow-up remains ongoing. HUTCHMED said the detailed data will be presented at a forthcoming medical meeting.
SANOVO Demonstrates Significant PFS Improvement
The SANOVO trial is a blinded, randomized, controlled Phase III study evaluating the efficacy and safety of ORPATHYS in combination with TAGRISSO against TAGRISSO alone in treatment-naïve patients in China. The study enrolled 326 patients with locally advanced or metastatic NSCLC harboring activating EGFR exon 19 deletions or L858R mutations together with MET overexpression. Participants were randomized 1:1 to receive TAGRISSO 80 mg once daily with either ORPATHYS or placebo. ORPATHYS was administered at 300/200 mg twice daily based on body weight. The trial’s primary endpoint was investigator-assessed PFS, while additional endpoints included independently assessed PFS, OS, objective response rate, duration of response, disease control rate, time to response and safety. HUTCHMED reported that the combination achieved its primary objective in both the high-MET population and the intention-to-treat population, demonstrating a significant PFS benefit over TAGRISSO monotherapy.
Targeting EGFR and MET Pathways Upfront
The SANOVO findings support an approach designed to address two important molecular pathways simultaneously in EGFR-mutated lung cancer. TAGRISSO is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) that targets EGFR-driven signaling, while ORPATHYS is an oral, selective MET TKI designed to inhibit abnormal MET pathway activation associated with mechanisms including gene amplification and protein overexpression. According to HUTCHMED, MET overexpression in treatment-naïve EGFR-mutated NSCLC can compromise the durability of EGFR-TKI monotherapy. By adding MET inhibition to EGFR-targeted treatment from the outset, the combination aims to address MET-driven biology earlier in the treatment journey. The companies reported that the safety profile of ORPATHYS plus TAGRISSO was consistent with the known safety profiles of the individual medicines, with no new safety findings identified in the SANOVO trial.
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Results Expand Development of ORPATHYS in NSCLC
The SANOVO results build on earlier clinical development of the ORPATHYS and TAGRISSO combination in patients whose EGFR-mutated NSCLC has progressed following EGFR-TKI treatment. The combination is already approved in China for patients with locally advanced or metastatic EGFR-mutated non-squamous NSCLC with MET amplification following progression on EGFR-TKI therapy, based on results from the SACHI Phase III trial. In August 2026, the global SAFFRON Phase III trial also reported statistically significant and clinically meaningful improvements in PFS and OS in patients with EGFR-mutated NSCLC and MET overexpression or amplification after progression on TAGRISSO. SANOVO now extends the development strategy into the first-line setting for treatment-naïve patients with MET overexpression. Lung cancer remains the leading cause of cancer death globally, while NSCLC accounts for approximately 80–85% of lung cancer cases. EGFR mutations are particularly prevalent in Asian populations, making biomarker-directed strategies addressing both EGFR and MET pathways clinically important. HUTCHMED and AstraZeneca jointly develop ORPATHYS, with AstraZeneca responsible for commercialization. Following the positive SANOVO results, HUTCHMED plans to share the findings with regulatory authorities as it works toward potentially expanding ORPATHYS-based treatment into the first-line setting in China.
Source: HUTCHMED press release
