HUTCHMED (00013.HK): SANOVO Phase III of ORPATHYS plus TAGRISSO meets primary endpoint in first-line EGFR-mutant NSCLC, with significant PFS benefit

NewTimeSpace News: On 31 August 2026, HUTCHMED (China) Limited (stock code: 00013) announced positive topline results from the SANOVO Phase III study in China: in treatment-naive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations and MET overexpression, the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) versus TAGRISSO monotherapy, in both the high-MET and intent-to-treat (ITT) patient populations.

According to the announcement, in both populations, the combination also demonstrated highly encouraging overall survival (OS) clinical benefit, one of the secondary endpoints of the study; the study will continue to follow up on these results, and the data will be presented at an upcoming academic conference. The safety profile of the combination was consistent with the known safety profiles of each drug, with no new safety signals identified.

SANOVO is a blinded, randomized, controlled Phase III clinical trial that enrolled 326 treatment-naive patients with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) and MET overexpression, randomized 1:1 to receive TAGRISSO 80 mg once daily combined with either ORPATHYS or placebo at 300/200 mg twice daily (dose depending on body weight), with investigator-assessed PFS as the primary endpoint (ClinicalTrials.gov: NCT05009836).

The announcement noted that, based on the SACHI Phase III study, the ORPATHYS and TAGRISSO combination has been approved in China for patients with EGFR-mutant locally advanced or metastatic NSCLC with MET amplification who progressed on EGFR TKI therapy; the SAFFRON global Phase III study in EGFR-mutant NSCLC patients with MET overexpression or amplification who progressed on TAGRISSO also announced positive topline results in August 2026, demonstrating statistically and clinically meaningful PFS and OS improvements. ORPATHYS was jointly developed by AstraZeneca and HUTCHMED, and is commercialized by AstraZeneca.

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