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Calithera Biosciences Initiates a Randomized Phase 2 Combination Trial of CB-839 in Patients with Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif., Aug. 07, 2017 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced the initiation of a randomized Phase 2 trial of CB-839, the company’s glutaminase inhibitor, combined with AFINITOR® (everolimus)‎ in patients with clear cell renal cell carcinoma.

“Despite the advances in the treatment of renal cell carcinoma, there remains significant unmet need for patients who have progressed following treatment with an anti-PD1 and/or tyrosine kinase inhibitors,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. “The initiation of this study marks an important milestone for our company, as it is the first randomized trial of CB-839 that we believe has the potential for U.S Food and Drug Administration (FDA) registration and approval. In recognition of the lack of treatment options available to patients with renal cell carcinoma, the FDA has granted Fast Track Designation to CB-839 in this setting.”

The randomized, double-blind, placebo controlled trial is designed to evaluate the safety and efficacy of CB-839 in combination with everolimus versus placebo with everolimus in approximately 250 patients with metastatic, clear cell renal cell carcinoma (RCC) patients who have been treated with at least two prior lines of systemic therapy including a VEGFR-targeting tyrosine kinase inhibitor and at least one of either CABOMETYX™ (cabozantinib) or an active PD-1/PD-L1 inhibitor. Patients will be randomized in a 2:1 ratio. The primary endpoint is progression free survival assessed by an independent review committee; overall survival will be assessed as a secondary endpoint. The multicenter, international study will be conducted at multiple sites in the United States, Europe and Canada. Clinical trial sites have been activated and the study is open for enrollment. For a listing of clinical sites and additional details about the clinical trial, please see