San Francisco, CA (UroToday.com) — Calithera Biosciences, Inc. a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, announced that it has completed patient enrollment in the ongoing CANTATA trial. CANTATA is a global, randomized double-blind clinical trial of the glutaminase inhibitor telaglenastat (CB-839) combined with cabozantinib, a standard of care, in patients with advanced or metastatic renal cell carcinoma (RCC) who have received one or two prior treatments. The study is designed with registrational intent. Exelixis, Inc. is providing cabozantinib for the trial through a material supply agreement with Calithera.
“We are grateful that both clinicians and patients have expressed real interest in the CANTATA trial, enabling us to complete enrollment ahead of schedule,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “This is an important milestone in the clinical progress of telaglenastat, our novel glutaminase inhibitor. Despite the introduction of new therapies, the treatment of patients with advanced renal cell carcinoma who have progressed on initial treatments remains a critical unmet need.”
The CANTATA trial (NCT03428217) is a global, randomized, double-blind trial designed to evaluate the efficacy and safety of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic RCC who have been treated with one or two prior lines of systemic therapy, including at least one vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab. In April 2018, the U.S. Food and Drug Administration granted Fast Track designation to telaglenastat in this indication. The CANTATA trial enrolled 445 patients at multiple centers globally. The primary endpoint is progression-free survival by blinded independent review, and a key secondary endpoint is overall survival. Calithera plans to report top-line efficacy and safety data from the trial in the second half of 2020.
Telaglenastat is an investigational first-in-class 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. Earlier this year, Calithera announced that a randomized Phase 2 trial of telaglenastat plus everolimus versus everolimus plus placebo (ENTRATA) met its primary endpoint of improving progression free survival, demonstrating proof of concept for telaglenastat in patients with advanced RCC.
Source: Ezez. 2019. “Calithera Biosciences, Inc. | Calithera Biosciences Completes Patient Enrollment in Randomized CANTATA Trial of Telaglenastat and Cabozantinib in Advanced Renal Cell Carcinoma”. Calithera Biosciences, Inc.. http://ir.calithera.com/news-releases/news-release-details/calithera-biosciences-completes-patient-enrollment-randomized-0?field_nir_news_date_value
Further Related Content:
ESMO 2019: CB-839 with Everolimus vs. Placebo with Everolimus in Patients with Renal Cell Carcinoma, the ENTRATA Phase 2 Study
ASCO GU 2019: CANTATA: Randomized, International, Double-Blind Study of CB-839 Plus Cabozantinib versus Cabozantinib Plus Placebo in Patients with Metastatic Renal Cell Carcinoma