|Calithera Biosciences Reports CB-839 Phase I Renal Cell Carcinoma Combination Data at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics|
“CB-839 is the first tumor metabolism drug to target a pathway that starves cancer cells by directly depriving them of a key nutrient. We are pleased to present combination data of CB-839 with everolimus that demonstrates high rates of disease control with a well-tolerated combination therapy,” said
Patients enrolled in the trial had advanced or metastatic disease and had received a median of two prior treatments, which included tyrosine kinase inhibitors, mTOR inhibitors, and checkpoint inhibitors. Patients were administered CB-839 in oral doses that ranged from 400-800 mg twice a day in combination with a fixed oral dose of everolimus at 10 mg once a day. The addition of CB-839 to full dose everolimus has been well tolerated, with a similar safety profile to the known profile of everolimus alone. Grade 3 events include two events of hyperglycemia and one event each of diarrhea, anemia and fatigue. On the basis of this efficacy and safety data, the company plans to continue development in combination therapy for clear cell renal cell carcinoma. Clear cell is the most common form of kidney cancer comprising 75%-85% of cases.
In addition, the following poster presentations will be presented at the meeting:
1 Choueiri, T, Escudier, B. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. The Lancet 2016 July; 17: 917-927.
About Calithera Biosciences
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Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of CB-839, and the company’s plans to continue development of CB-839 in combination therapy for clear cell renal cell carcinoma. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's most recent Quarterly Report on Form 10-Q filed with the