Hong Kong, Shanghai & Florham Park, NJ – August 31, 2026
HUTCHMED (China) Limited announced positive high-level results from the SANOVO Phase III trial, showing that ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with TAGRISSO alone in treatment-naïve patients with locally advanced or metastatic EGFR-mutated, MET-overexpressing non-small cell lung cancer (NSCLC) in China. The benefit was observed in both the high-MET population and the intention-to-treat population. The combination also demonstrated an encouraging signal for overall survival (OS), although the trial will continue follow-up. The findings strengthen HUTCHMED’s strategy of developing biomarker-directed treatment approaches for patients whose tumors carry both EGFR mutations and MET overexpression.
HUTCHMED Advances Biomarker-Directed First-Line NSCLC Treatment
The SANOVO trial evaluates whether simultaneously targeting EGFR and MET can improve outcomes compared with EGFR inhibition alone in patients receiving their first systemic treatment. A total of 326 treatment-naïve patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletion or L858R mutations and MET overexpression were randomized to receive TAGRISSO 80 mg once daily plus ORPATHYS or placebo. The positive PFS result provides clinical support for addressing MET overexpression earlier in the treatment journey rather than waiting until resistance develops. For HUTCHMED, the result is particularly important because it extends the development strategy for ORPATHYS plus TAGRISSO beyond previously treated patients into the first-line setting. The companies said the data will be presented at a forthcoming medical meeting and are expected to support discussions with regulatory authorities in China.
ORPATHYS and TAGRISSO Combination Shows Phase III Activity
The ORPATHYS plus TAGRISSO combination was associated with a statistically significant improvement in PFS in both the high-MET and overall trial populations. The company did not disclose detailed median PFS values or hazard ratios in the high-level announcement, limiting the ability to quantify the magnitude of the benefit at this stage. Overall survival also showed an encouraging clinical benefit in both populations, but these data remain subject to continued follow-up. The safety profile was consistent with the known profiles of the individual medicines, with no new safety findings reported. The results build on earlier development of the combination in patients who develop MET-driven resistance following EGFR-TKI treatment, including positive results from the SAFFRON Phase III trial and the China SACHI Phase III trial. The SANOVO findings therefore broaden the potential clinical role of the combination by supporting investigation before disease progression rather than exclusively after resistance emerges.
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HUTCHMED Builds on ORPATHYS Development Strategy
The SANOVO outcome adds to the growing clinical development program for savolitinib, an oral and selective MET tyrosine kinase inhibitor jointly developed by HUTCHMED and AstraZeneca. ORPATHYS is already approved in China for several settings involving MET-driven disease, including MET exon 14 skipping alteration-positive NSCLC, while the combination with TAGRISSO is approved for EGFR-mutated NSCLC with MET amplification after progression on EGFR-TKI therapy. The new Phase III evidence moves the combination toward a potentially broader frontline treatment strategy for MET-overexpressing EGFR-mutated NSCLC. The company plans to continue follow-up of SANOVO patients and share detailed findings at a future medical meeting. Importantly, the announcement currently provides high-level results rather than the complete dataset, so the ultimate clinical significance will depend on the detailed PFS analysis, OS maturity, response data and full safety results. For cGxP.wire, the key development is the potential expansion of a biomarker-directed ORPATHYS and TAGRISSO regimen into the first-line setting in China.
Source: HUTCHMED, ORPATHYS press relese
