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Hutchmed, AstraZeneca Begin Phase III Study of Orpathys, Imfinzi in MET-Driven Renal Cancer

NEW YORK – Hutchmed and AstraZeneca on Monday began a Phase III trial of Hutchmed's c-Met inhibitor savolitinib (Orpathys) and AstraZeneca's PD-L1 inhibitor durvalumab (Imfinzi) in patients with MET-driven advanced papillary renal cell carcinoma.

The open-label study will randomize 200 treatment-naïve patients with MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma to receive savolitinib plus durvalumab, durvalumab alone, or the standard-of-care kinase inhibitor sunitinib (Pfizer's Sutent).

The companies are primarily interested in assessing patients' progression-free survival on savolitinib plus durvalumab relative to sunitinib. Researchers will also assess patients' overall survival, objective response rate, duration of response, disease control rate, time to second progression, safety, pharmacokinetics, and quality of life.

The two companies previously studied the savolitinib-durvalumab combination in renal cancer patients in a Phase I/II trial. In that study, 57 percent of patients with MET-driven tumors responded to the combination. The median duration of response was 9.4 months, median progression-free survival was 10.5 months, and median overall survival was 27.4 months.

Hutchmed is also studying savolitinib in combination with AstraZeneca's EGFR inhibitor osimertinib (Tagrisso) in patients with non-small cell lung cancer who harbor MET and EGFR mutations and as a monotherapy in patients with metastatic MET-amplified gastric cancer.

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