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AstraZeneca, Hutchmed Launch Phase III Randomized Trial of Orpathys, Tagrisso in China

NEW YORK – Hutchmed and AstraZeneca said on Wednesday that they are starting a Phase III trial, called SANOVO, in China to explore the activity of the MET inhibitor savolitinib (Orpathys) and the EGFR inhibitor osimertinib (Tagrisso) as a first-line treatment for advanced non-small cell lung cancer patients with tumors overexpressing MET and harboring EGFR mutations.

Hong Kong-headquartered Hutchmed and AstraZeneca have a global licensing agreement to codevelop and commercialize savolitinib, which is marketed in China for NSCLC patients with MET exon 14 skipping tumor alterations who have progressed on systemic therapy or cannot receive chemotherapy. AstraZeneca's osimertinib is a third-generation EGFR inhibitor that is globally available for several EGFR-mutated NSCLC indications.

In the recently launched Phase III, randomized trial, Hutchmed and AstraZeneca are evaluating the safety and efficacy of the combination of these drugs against single-agent osimertinib plus placebo in more than 300 locally advanced or metastatic NSCLC patients with EGFR mutations and MET overexpression in their tumors. The first patient was treated in the study on Sept. 7.

Researchers will track study participants' median progression-free survival, which will also be assessed by an independent review committee. Other endpoints of interest in the trial are median overall survival, objective response rate, duration of response, disease control rate, time to response, and safety.

The companies said in a statement that the decision to launch this randomized Phase III trial was based on early hints of activity seen in the single-arm Phase II SAVANNAH trial. In that study, AstraZeneca is exploring the activity of the osimertinib-savolitinib combo in advanced, EGFR-mutated NSCLC patients who have become resistant to osimertinib due to MET amplification or overexpression.