Syndax to Host Conference Call to Provide Update on the Phase 3 Breast Cancer Trial (E2112) and to Announce its Registration Trial of Entinostat with Keytruda in PD-(L)1 Refractory Non-Small Cell Lung Cancer
As planned, ECOG-ACRIN is confidentially holding the findings from the PFS analysis until reporting final OS results. After recently performing the third interim OS analysis, ECOG-ACRIN informed the Company that the trial will continue as planned until either it observes an OS benefit or the final target number of events occur. The next interim analysis for the OS primary endpoint is scheduled for 2Q19 with additional interim analyses every six months. Based on the trial design, any positive OS assessment would enable the Company to file for full regulatory approval.
"While the PFS analysis did not show a statistically significant benefit, E2112 was primarily designed to determine whether the combination of entinostat and exemestane could improve OS based on the compelling OS results obtained in the Phase 2b ENCORE 301 trial," said
Update on entinostat registration plans in PD-1 / platinum pre-treated NSCLC patients
The Company also provided an update on its regulatory strategy for entinostat in combination with Merck's anti-PD1 therapy, KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) whose disease has progressed after both platinum-based chemotherapy and PD-1 antagonist therapy.
The Company previously presented data from the Phase 2 ENCORE 601 NSCLC cohort that enrolled patients who received prior chemotherapy and anti-PD-(L)1 treatment, at the 2018
"Patients whose disease has progressed despite treatment with PD-1 antagonists represent a very substantial unmet medical need, and efforts to identify novel biomarkers with clinical utility represent one of the most exciting areas of ongoing research," said
The Company announced plans to initiate a randomized registration enabling trial comparing the entinostat-KEYTRUDA combination to standard of care chemotherapy in patients whose disease has progressed after both platinum-based chemotherapy and PD-1 antagonist therapy. Following discussions with the
Conference Call and Webcast
The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com. Alternatively, the conference call may be accessed through the following:
Conference ID: 4088939
International Dial-in Number: 281-542-4259
Live Webcast: https://edge.media-server.com/m6/p/o9ka7y73
For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com.
Entinostat, a selective, oral, once-weekly inhibitor of class I histone deacetylases (HDACs), has been shown to resensitize Hormone Receptor positive (HR+) advanced breast cancer to endocrine therapy, and is currently being evaluated in a pivotal Phase 3 clinical trial in combination with exemestane for advanced HR+ breast cancer, an indication for which it has been granted Breakthrough Therapy Designation by the
The E2112 trial (NCT0211528) is a randomized, double-blind, placebo-controlled Phase 3 trial of entinostat, Syndax's Class I selective HDAC inhibitor, plus exemestane, an aromatase inhibitor, in patients with hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have experienced disease progression following treatment with a non-steroidal aromatase inhibitor (NSAI). The trial, operating under a Special Protocol Assessment was designed, in collaboration with the
Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company is developing its lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, in combination with exemestane and several approved PD-1/PD-L1 antagonists. The Company's pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, as well as a portfolio of potent and selective inhibitors targeting the binding interaction of Menin with MLLr. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.
Syndax's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
KEYTRUDA® is a registered trademark of
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