Hutchmed has completed subject enrolment in the randomised Phase III SANOVO trial in China, which is evaluating the combination of Orpathys (savolitinib) and Tagrisso (osimertinib) as a first-line treatment for specific non-small cell lung cancer (NSCLC) patients.
The blinded, controlled trial targets previously untreated individuals with locally advanced or metastatic NSCLC who have activating epidermal growth factor receptor (EGFR) mutations and overexpression of mesenchymal–epithelial transition factor (MET).
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Its objective is to assess the safety and efficacy of the combination therapy against Tagrisso alone.
Investigators will primarily focus on progression-free survival (PFS) as the key endpoint of the study.
Other important endpoints include PFS as evaluated by an independent review committee, disease control rate (DCR), objective response rate (ORR), overall survival (OS), time to response (TTR), safety and duration of response (DoR).
Topline outcomes from the SANOVO trial are anticipated in the second half of 2026. In the event the results are positive, Hutchmed expects to proceed with a supplementary new drug application submission to the National Medical Products Administration (NMPA) of China.
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By GlobalDataOrpathys, a selective MET tyrosine kinase inhibitor (TKI), is being co-developed by Hutchmed and AstraZeneca, with the latter in charge of its commercialisation.
In China, this oral therapy is approved for the treatment of adults with locally advanced or metastatic NSCLC having alterations of MET exon 14 skipping.
Orpathys is currently being explored for several tumour types, including kidney, gastric and lung cancers, both as a standalone and in conjunction with other therapies.
AstraZeneca is actively exploring the use of irreversible EGFR TKI, Tagrisso, for individuals at various stages of EGFRm NSCLC.
Hutchmed concluded the enrolment for its Phase II trial of fanregratinib (HMPL-453) in March 2025, which is aimed at treating intrahepatic cholangiocarcinoma (IHCC) patients with fibroblast growth factor receptor 2 (FGFR2) fusion/rearrangement.
