ECOG-ACRIN Provides Syndax Pharmaceuticals With Results of Phase 3 E2112 Trial of Entinostat Plus Exemestane in Patients with HR+, HER2- Breast Cancer

WALTHAM, MA, USA I May 21, 2020 I Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) today announced receipt of the final results of E2112, the Phase 3 clinical trial conducted by ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), that evaluated the investigational compound entinostat, Syndax's class I HDAC inhibitor, plus exemestane in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have progressed on a non-steroidal aromatase inhibitor. The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival (OS) benefit over hormone therapy alone.  

"We're disappointed that the combination of entinostat and exemestane did not demonstrate a survival benefit in this historically difficult-to-treat patient population," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "On behalf of the entire Syndax team, we extend our sincerest gratitude to all the patients, their families and the investigators who participated in this important trial, as well as our colleagues at ECOG-ACRIN and the NCI. Based on these results, we will not be filing a New Drug Application with the U.S. Food and Drug Administration for metastatic breast cancer."

Dr. Morrison added, "We remain focused on advancing our broader portfolio, including our targeted therapy, SNDX-5613, an inhibitor of the Menin-MLL interaction, and axatilimab, our anti-CSF-1R monoclonal antibody. Later this year, we expect to present additional clinical data from the AUGMENT-101 trial of SNDX-5613 in adults with relapsed/refractory acute leukemias. Based on preclinical data reported to date, as well as recent Phase 1 results representing the first clinical evidence that inhibition of the Menin-MLL1 interaction can induce response in patients with genetically-defined acute leukemias, we believe SNDX-5613 has the potential to offer patients with both NPM1 mutant acute myeloid leukemia and MLL-r acute leukemias a much-needed, effective therapeutic option. We also anticipate the presentation of additional results from our ongoing Phase 1/2 trial of axatilimab in patients with chronic graft versus host disease in the fourth quarter of this year."

The E2112 trial was designed and conducted independently by ECOG-ACRIN under the sponsorship of the NCI, which is part of the National Institutes of Health. The double-blind, placebo-controlled trial randomized a total of 608 patients with HR+, HER2- advanced breast cancer to receive exemestane in combination with entinostat or placebo.

About Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's pipeline includes SNDX-5613, a highly selective inhibitor of the Menin–MLL binding interaction, axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and entinostat, a class I HDAC inhibitor. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.

SOURCE: Syndax Pharmaceuticals

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