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Syndax Pharmaceuticals Announces Publication of Clinical Study Demonstrating that Entinostat Targets Resistance Pathways in Breast Cancer
Date:5/14/2013

for evaluation of protein lysine acetylation as a biomarker of entinostat activity.

Based on intent-to-treat analysis, patients treated with entinostat saw improved median PFS to 4.3 months, versus 2.3 months in patients treated with placebo (hazard ratio 0.73; 95% confidence interval, 0.50 to 1.07; one-sided P = .055; two-sided P = .11). Overall survival was an exploratory endpoint, and median survival improved to 28.1 months in entinostat-treated patients versus 19.8 months in placebo-treated (hazard ratio 0.59; 95% confidence interval, 0.36 to 0.97; P = .036). Fatigue and neutropenia were the most frequent grade 3/4 toxicities; treatment discontinuation because of adverse events was higher in the entinostat group versus the placebo group (11 percent versus 2 percent). Protein lysine hyperacetylation in the entinostat-treated biomarker subset was associated with prolonged progression-free survival.

"Given the need for well tolerated therapies that extend the benefit of hormone therapy in postmenopausal women with breast cancer, our ENCORE 301 study supports the evaluation of entinostat not just in breast cancer, but also in other solid tumors," said Arlene M. Morris , Syndax's chief executive officer.  "We are actively working to move entinostat into a confirmatory pivotal study this fall."

In addition to the breast cancer study publication Syndax just announced a license deal to commercialize a first-in-class lung cancer treatment strategy with entinostat in combination with erlotinib developed by the University of Colorado and based on results published in Journal of Clinical Oncology in 2012.  Click here to see the release. 

About Entinostat for Breast Cancer
Each year, approximately 207,000 women in the United States have breast cancer; 20,000 of these women have metastatic br
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SOURCE Syndax Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
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