On December 6, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that clinical data from its lead product candidate CB-839, a first-in-class glutaminase inhibitor, will be presented at the 2016 San Antonio Breast Cancer Symposium, December 6-10, 2016 in San Antonio, Texas (Press release, Calithera Biosciences, DEC 6, 2016, View Source;p=RssLanding&cat=news&id=2227919 [SID1234516955]). The data demonstrate the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with advanced/metastatic triple negative breast cancer (TNBC).
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"Triple negative breast cancer in the advanced and metastatic population remains a significant unmet need. We are particularly pleased to observe responses with CB-839 plus paclitaxel in taxane-refractory patients," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.
Dr. Angela DeMichele from the University of Pennsylvania will present in a poster session, "Phase I study of CB-839, a small molecule inhibitor of glutaminase, in combination with paclitaxel in patients with triple negative breast cancer," (Abstract P6-11-05). The abstract was selected for presentation on Saturday, December 10, 2016. Eligible patients must have locally advanced/metastatic TNBC, with prior paclitaxel treatment allowed. As of November 25, 2016, 28 triple negative breast cancer patients had been treated with doses of CB-839 of 400, 600 or 800 mg bid in combination with 80 mg/m2 IV paclitaxel, weekly, three weeks out of four; 23 were evaluable for response. The majority of patients had received at least three prior lines of therapy, with 43% of patients treated with five or more prior therapies in the advanced/metastatic setting. Most patients had received prior taxane therapy in either the neo-adjuvant or metastatic setting. Among evaluable patients treated with CB-839 doses of at least 600 mg bid (n=16), there are 5 partial responses (31%) and disease control (response or stable disease) in 11 patients (69%). In addition, the combination overcomes resistance to paclitaxel in heavily pretreated TNBC patients. There is a 38% response rate and 50% disease control rate in patients who received prior taxanes in the metastatic setting. There is a 50% response rate among taxane-refractory African American patients, consistent with higher glutamine utilization observed in tumors from this population.1
The combination of CB-839 and paclitaxel has been well tolerated to date, with adverse events that have been easily manageable and reversible, including several paclitaxel related toxicities. There was one case of dose-limiting, recurrent grade 3 neutropenia at the 400 mg dose level, which led to a reduction in the dose of paclitaxel for that patient. The most frequent adverse event ≥ Grade 3 is neutropenia (n=6).