Item 7.01. Regulation FD Disclosure.

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Syndax Pharmaceuticals, Inc., a Delaware corporation (“we,” “us,” or the “Company”) announces today that ECOG-ACRIN Cancer Research Group, the sponsor of our Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, E2112, notified us in advance of their October 24 – 26 biannual group meeting that the trial has passed its fifth and final interim overall survival (OS) analysis.  The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+, HER2- breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a strong OS benefit.  

The trial will now continue until the final OS analysis, which will happen when 410 deaths from among the 608 patients enrolled have occurred.  Based upon our modeling of the assumed event rate, we expect this final analysis to occur in the second quarter of 2020.  We have included in this filing a revised corporate presentation containing the update to the E2112 trial.

A copy of the above referenced presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. This information, including the information contained in the presentation furnished as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated by reference into any of the Company’s filings, whether made before or after the date hereof, regardless of any general incorporation language in any such filing.

(d) Exhibits.

Syndax Pharmaceuticals Inc Exhibit
EX-99.1 2 sndx-ex991_6.htm EX-99.1 sndx-ex991_6.pptx.htm Corporate presentation | October 2019 Determined to realize a future in which people with cancer live longer and better than ever before Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,…
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Syndax Pharmaceuticals, Inc (Syndax) is a clinical stage biopharmaceutical company focused on developing a pipeline of combination therapies in multiple cancer indications. The Company’s product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from its Phase IIb clinical trial, ENCORE 301, is being evaluated in a Phase III clinical trial for advanced hormone receptor positive breast cancer. It is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body’s immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase Ib/II clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer.

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