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Survival Benefit With Syndax Pharmaceuticals' Entinostat Maintained in Women with Advanced Breast Cancer
Date:12/7/2011

WALTHAM, Mass., Dec. 7, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. announced today that, with a 23-month patient follow up of ENCORE 301, a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of exemestane with and without entinostat in 130 patients with locally recurrent or metastatic estrogen receptor-positive breast cancer, the median overall survival of exemestane plus entinostat patients reached 26.9 months versus 19.8 months for exemestane plus placebo. This represents a 42% reduction (p=0.04) in the risk of dying for these patients. Previously presented data from ENCORE 301 demonstrated a near doubling in the progression-free survival (PFS) (4.3 vs. 2.3 months) with exemestane plus entinostat and the identification of a subset of these patients whose median PFS reached 8.5 months. The updated data is being presented today, December 7, 2011, at the San Antonio Breast Cancer Symposium in San Antonio, Texas. 

"It is both exciting and encouraging to see after two years of follow up that patients treated with entinostat and exemestane benefited from an additional seven months of overall survival," said Denise A. Yardley, MD, breast program leader, senior investigator at the Sarah Cannon Research Institute and principal investigator of the study. "This encouraging signal of not only a progression-free survival advantage (4.3 months vs 2.3 months) but also of an overall survival benefit for this combination, coupled with an excellent safety and tolerability profile, provide the platform for the larger scale confirmatory, randomized, phase 3 study anticipated to begin enrollment in the first half of 2012."

Highlights of the data to be presented include:

  • Overall survival: 26.9 months for exemestane + entinostat vs. 19.8 months for exe
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SOURCE Syndax Pharmaceuticals, Inc.
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