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Syndax Pharmaceuticals to Present Updated Overall Survival Data With Entinostat in Metastatic Breast Cancer at ASCO
Date:5/29/2012

overall survival benefit," said Denise A. Yardley, MD, breast program leader, senior investigator at the Sarah Cannon Research Institute and principal investigator of the study. "Moreover, the addition of entinostat to exemestane translated into an increase in progression-free survival of over six months in the subset of patients treated with this novel combination that demonstrated protein lysine hyperacetylation.  This suggests that evaluating evidence of protein hyperacetylation may be an exciting opportunity to explore whether we could use this biomarker to identify patients most likely to benefit from the addition of entinostat to standard hormone therapy.  These results continue to support the promise of entinostat for women with advanced breast cancer and I am eager to move forward with the confirmatory phase 3 study."

ENCORE 301 (ENtinostat Combinations Overcoming REsistance) was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of exemestane with and without entinostat in 130 post-menopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer, progressing on treatment with the non-steroidal aromatase inhibitors anastrozole or letrozole.  The study hit the primary endpoint of progression-free survival and preliminary analysis indicated an overall survival benefit. Entinostat was well tolerated with fatigue, nausea and uncomplicated neutropenia as the most commonly occurring adverse events. Pharmacodynamic analysis in a subset of patients linked for the first time a readout of histone deacetylase inhibitor activity with clinical outcome.

The abstract titled, "Characterization of the overall survival benefit in ENCORE 301, a randomized placebo-controlled phase 2 study of exemestane with and without entinostat in ER+ post-menopausal women with metastatic breast cancer" highlighted the following results:

  • Analysis of OS across m
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SOURCE Syndax Pharmaceuticals, Inc.
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