Calithera Biosciences announced that it has completed patient enrollment in the ongoing Phase 2 ENTRATA trial. ENTRATA is a randomized clinical study of the glutaminase inhibitor CB-839 combined with everolimus versus placebo with everolimus for the treatment of advanced renal cell carcinoma. CB-839 now has the International Nonproprietary Name telaglenastat, as recommended by the World Health Organization. The ENTRATA trial is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival. Calithera plans to report efficacy and safety data from the trial in the second half of 2019. Telaglenastat is also being investigated in the CANTATA trial, which will enroll approximately 400 patients and is designed with registrational intent. It is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced clear cell RCC who have been treated with one or two prior lines of systemic therapy. The primary endpoint is PFS by blinded independent review, and a key secondary endpoint is overall survival.
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