Calithera Reports Phase 2 CANTATA Trial of Telaglenastat for Advanced Renal Cell Carcinoma Fails to Reach Primary Endpoint

Calithera Reports Phase 2 CANTATA Trial of Telaglenastat for Advanced Renal Cell Carcinoma Fails to Reach Primary Endpoint TrialsiteN

Calithera Biosciences announced topline results from the CANTATA clinical study, which was designed to evaluate the company’s glutaminase inhibitor telaglenastat in combination with cabozantinib versus placebo in patients with advanced or metastatic renal cell carcinoma (RCC). As compared to treatment with cabozantinib, the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression free survival (PFS) in the study population. As a result of the outcome of CANTATA, Calithera will reduce its workforce by approximately 35 percent to allow the company to focus on ongoing programs.

The global, randomized, double-blind CANTATA trial enrolled 444 patients with advanced or metastatic RCC who had been treated with one or two prior lines of systemic therapy, including at least one vascular endothelial growth factor (VEGF)-pathway targeted anti-angiogenic therapy or the combination of nivolumab and ipilimumab. The primary study endpoint is PFS by blinded independent review. The median PFS was 9.2 months among patients treated with telaglenastat and cabozantinib as compared to 9.3 months with cabozantinib and placebo. Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. The frequency and severity of adverse events in the telaglenastat-treated population were comparable to that of cabozantinib alone. 

Calithera will submit the CANTATA results for presentation at a medical meeting.

About Telaglenastat

Telaglenastat (CB-839) is an investigational, first-in-class, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. While normal cells use glucose to meet cellular energy demands, tumor cells have a unique oncometabolism that increases their dependence on glutamine to fuel growth and survival. 

Calithera is conducting the randomized Phase 2 KEAPSAKE trial to evaluate telaglenastat in patients with advanced non-small cell lung cancer harboring KEAP1/NRF2 mutations.

About Renal Cell Carcinoma

Renal cell cancer (also called kidneycancer or renal cell adenocarcinoma) is a disease in which malignant (cancer) cells are found in the lining of tubules (very small tubes) in the kidney. Treatment may include removing the entire kidney or its affected part. It may also include destroying the tumor with radiowaves or by freezing it. If the carcinoma has spread beyond the kidneys, options include immunotherapy, molecularly targeted therapies, or localized radiation therapy.