On February 4, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported 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 (RCC) (Press release, Calithera Biosciences, FEB 4, 2019, View Source [SID1234535231]). CB-839 now has the International Nonproprietary Name (INN) telaglenastat, as recommended by the World Health Organization.
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"The ENTRATA trial is the first randomized trial evaluating the glutaminase inhibitor telaglenastat. There is ample evidence demonstrating the potential of glutaminase inhibition to block growth and survival of cancer cells," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that patient enrollment is now complete and look forward to learning more from ENTRATA about how this promising mechanism could help heavily pre-treated patients with advanced renal cancer."
The ENTRATA trial (NCT03163667) 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 (PFS). Calithera plans to report efficacy and safety data from the trial in the second half of 2019.
Telaglenastat is an investigational, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. RCC tumors commonly exhibit metabolic alterations that increase their dependence on glutamine. In preclinical studies, telaglenastat produced synergistic antitumor effects when used in combination with standard-of-care RCC therapies.
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.