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Hutchmed, AstraZeneca Begin Phase III Trial in NSCLC With EGFR, MET Mutations

NEW YORK – Hutchmed and AstraZeneca on Tuesday began a Phase III trial in China of their MET inhibitor savolitinib (Orpathys) and EGFR inhibitor osimertinib (Tagrisso) combination in advanced or metastatic EGFR-positive, MET-amplified non-small cell lung cancer.

The randomized, controlled study, called SACHI, will enroll up to 250 patients to evaluate the savolitinib-osimertinib combination versus the standard-of-care platinum-based doublet-chemotherapy regimen. Patients will be screened for EGFR mutations and with MET amplification after disease progression on an EGFR inhibitor therapy. The primary endpoint is progression-free survival, and the researchers will also assess overall survival, objective response rate, duration of response, disease control rate, time to response, and safety.

In Asia, around 30 percent to 40 percent of patients have EGFR-mutated NSCLC. In a Phase Ib study in EGFR-mutated, MET-amplified NSCLC, treatment with savolitinib and osimertinib led to a response in 44 percent of patients. Among patients who had circulating tumor DNA (ctDNA) clearance, the median progression-free survival was 9.1 months.

Hutchmed and AstraZeneca are also studying savolitinib plus osimertinib as a first-line treatment for EGFR-positive, MET-amplified NSCLC; in MET-amplified gastric cancers; and in combination with AstraZeneca's PD-L1 inhibitor durvalumab (Imfinzi) in patients with MET-driven advanced papillary renal cell carcinoma.

Earlier this year, savolitinib was approved in China for NSCLC patients who have progressed on systemic therapy, are unable to receive chemotherapy, and harbor MET exon 14 skipping alterations in their tumors.