China National Medical Products Administration (NMPA) has granted acceptance and priority review for the new drug application (NDA) for HUTCHMED’s ORPATHYS (savolitinib) and TAGRISSO (osimertinib) combination for patients with locally advanced or metastatic non-small cell lung cancer.
This is specifically indicated for individuals positive for epidermal growth factor receptor (EGFR) mutations and MET amplification following disease progression on first-line EGFR inhibitor therapy.
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The NDA is underpinned by outcomes from the Phase III SACHI trial that assessed the safety and efficacy of the combination versus the standard platinum-based doublet-chemotherapy.
HUTCHMED is now set to gain a milestone payment from AstraZeneca.
Progression-free survival (PFS) was the primary endpoint as evaluated by investigators. Secondary endpoints include PFS by independent review, and overall survival.
The Independent Data Monitoring Committee for the trial determined that the primary endpoint of the pre-defined primary endpoint of PFS was met during a planned interim analysis, leading to the conclusion of subject enrolment in the study.
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By GlobalDataIn December 2024 the NMPA awarded breakthrough therapy designation to the combination.
HUTCHMED research and development head and chief medical officer Dr Michael Shi stated: “This marks the first regulatory filing for the ORPATHYS and TAGRISSO combination.
“We and our partner AstraZeneca have been exploring this combination globally, through an array of late-stage clinical trials including the TATTON, SAVANNAH, SAFFRON and ORCHARD studies, and we hope to bring this all-oral, chemotherapy-free treatment option to patients with MET-driven lung cancer in the near future.”
The collaboration between HUTCHMED and AstraZeneca, which began in 2011, facilitates the joint development and commercialisation of ORPATHYS.
HUTCHMED oversees the drug’s development in China, while AstraZeneca oversees its global development.
Additionally, HUTCHMED is tasked with the marketing authorisation, manufacture and supply of ORPATHYS in China, with AstraZeneca handling its commercialisation there and internationally.
HUTCHMED previously agreed to sell a 45% equity interest in Shanghai Hutchison Pharmaceuticals, a non-core, non-consolidated joint venture, for $608m to GP Health Service Capital and Shanghai Pharmaceuticals Holding.
