Benzinga | Nov 1, 2021 04:54AM EDT

HUTCHMED, AstraZeneca Initiate SAMETA Global Phase III Trial of Savolitinib in Combination with PD-L1 Inhibitor IMFINZI in Patients with MET-Driven Advanced Papillary Renal Cell Carcinoma

HUTCHMED (China) Limited ("HUTCHMED") (NASDAQ:HCM) and AstraZeneca PLC ("AstraZeneca") (NASDAQ:AZN) have initiated SAMETA, a global Phase III study of savolitinib (ORPATHYS(r) in China), an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, in combination with AstraZeneca's PD-L1 inhibitor IMFINZI(r) (durvalumab) in patients with MET-driven advanced papillary renal cell carcinoma ("PRCC"). The first patient received their first dose on October 28, 2021.

The Phase III trial is an open-label, randomized, controlled study in treatment-nave patients with MET-driven, unresectable and locally advanced or metastatic PRCC, to evaluate the efficacy and safety of savolitinib in combination with IMFINZI(r), compared to single agent IMFINZI(r) or single agent SUTENT(r) (sunitinib), an oral multi-kinase inhibitor considered the standard-of-care treatment option in PRCC. The primary endpoint of the study is median progression free survival ("PFS"). Other endpoints include median overall survival ("OS"), objective response rate ("ORR"), duration of response ("DoR"), 6-months and 12-months disease control rate ("DCR"), time to second progression (PFS2), safety, pharmacokinetics ("PK") and quality of life. Additional details may be found at clinicaltrials.gov, using identifier NCT05043090.