US-based biopharmaceutical firm Exelixis has completed patient enrolment in its METEOR Phase III pivotal trial of cabozantinib to treat in patients with metastatic renal cell carcinoma (RCC).
The trial is designed for RCC patients who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor (TKI).
Progression-free survival (PFS) is the primary endpoint of the trial, while secondary endpoints include overall survival and objective response rate.
Top-line efficacy and safety data from the trial are expected to be reported in the second quarter of 2015.
Dana-Farber Cancer Institute clinical director of the Lank Centre for Genitourinary Oncology and director of the kidney cancer centre Toni Choueiri said: "METEOR was designed to evaluate cabozantinib's potential as a treatment for metastatic renal cell carcinoma, an aggressive form of the disease that is usually incurable.
"Recent drug development efforts in RCC have focused on single targets, but there is a compelling body of evidence suggesting a potential advantage in targeting the VEGFR and MET signalling pathways simultaneously.
"Since cabozantinib inhibits both of these pathways, this trial provides an exciting test of this hypothesis."
A total of 650 patients have been enrolled in the open-label, event-driven trial, which is being conducted at about 200 sites in up to 26 countries, and enrolment has been weighted toward Western Europe, North America, and Australia.
In the trial, patients will be randomised 1:1 to receive 60mg of cabozantinib daily or 10mg of everolimus daily and have been stratified based on the number of prior VEGFR TKI therapies received, and on commonly applied RCC risk criteria developed by Motzer et al.
Exelixis president and CEO Michael Morrissey said: "With enrolment in METEOR completed, Exelixis has achieved one of its major objectives for the second half of the year.
"We are grateful for the oncology community's interest and support, as reflected in the trial's rapid enrolment, and we look forward to delivering top-line results from METEOR in the second quarter of 2015."
Currently, COMETRIQ (cabozantinib) is approved by the US Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).