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Syndax Pharmaceuticals' Entinostat Plus Erlotinib Improves Survival in Select NSCLC Patients
Date:12/9/2010

rin expression has been shown preclinically to increase sensitivity to EGFR inhibitors thereby restoring sensitivity to the standard of care treatment. E-cadherin, which can be measured easily in tumors, is therefore a potentially relevant clinical biomarker to select patients for treatment with erlotinib plus entinostat."

The primary endpoint of the study was four-month progression free survival rate with progression free survival (PFS) and overall survival (OS) as additional endpoints. In the unselected patient population made up of 132 evaluable patients, entinostat plus erlotinib appeared comparable in terms of PFS and survival. In the E-cadherin high sub-group (N = 26), entinostat plus erlotinib was associated with improved PFS and survival. The median PFS for the patients in the E-cadherin high

group treated with entinostat and erlotinib was 3.7 months vs. 1.9 months for the group treated with placebo and erlotinib (Hazard ratio 0.55) with a p-value of 0.19. The median survival was 9.4 months in the subgroup treated with entinostat and erlotinib vs. 5.4 months for those treated with placebo and erlotinib (Hazard ratio 0.36) with a p-value of 0.03.

Entinostat/erlotinib was tolerable with no unexpected adverse events and a manageable safety profile.

"Directing therapy based on the individual biology of a patient's tumor is finally driving better outcomes for patients with lung cancer," said Joanna Horobin, M.D., president and chief executive officer of Syndax. "Having seen improvement in PFS and overall survival in patients with tumors expressing high levels of e-cadherin who received entinostat and erlotinib, we now have a clear path forward. We look to add to treatment options as we evaluate entinostat with erlotinib in further randomized studies to be initiated next year in a selected patient population of NSCLC patients with high levels of E-cadherin."

The abstract "Molecular Analysis Identifies A Subset Of Non-small C
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SOURCE Syndax Pharmaceuticals, Inc.
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