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LONDON, UK / ACCESSWIRE / May 21, 2018 / If you want access to our free research report on Syndax Pharma, Inc. (NASDAQ: SNDX), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=SNDX as the Company's latest news hit the wire. On May 17, 2018, the Company, which is a clinical stage biopharmaceutical organization developing an innovative pipeline of cancer therapies, declared results from multiple cohorts of the ongoing Phase-2 ENCORE 601 trial of Entinostat in combination with KEYTRUDA (pembrolizumab), Merck's anti- programmed death receptor-1 (PD-1) therapy. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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About ENCORE Trial

ENCORE 601 is a Phase-1b/2 trial designed to assess the efficacy and safety of entinostat in combination with pembrolizumab for multiple cohorts of PD-(L)1 treatment-naïve and pre-treated cancers, including non-small cell lung cancer (NSCLC), and melanoma and microsatellite stable colorectal cancer (MSS-CRC). This study encompasses a broad biomarker assessment of pre- and on-treatment blood and tumor samples from all patient cohorts, in order to identify a patient enrichment strategy to predict improved clinical benefits for various cohorts and to guide the design of future registration-directed studies.

Results from the Trial

The data for the ENCORE 601 program affirms the potential of the entinostat-pembrolizumab combination to offer an effective therapeutic option across a variety of indications. The Company has identified a potential registration pathway in NSCLC and looks forward to providing further updates as its plans come together.

Update on NSCLC

The PD-(L)1 pre-treated NSCLC cohort enrolled patients who had previously received chemotherapy and anti-PD-(L)1 treatment. This cohort provides the most mature dataset from the Company's ongoing biomarker analyses.

At the data cut-off point, there were 6 confirmed partial responses (PRs) among the first 57 patients enrolled, for an objective response rate (ORR) of 11% (95% CI: 4-21%) among patients treated with the entinostat-pembrolizumab combination regimen. Besides, 4 out of the 6 responders were negative for PD-(L)1 expression at study entry, and 22 out of 57 enrolled patients were refractory to prior PD-(L)1 therapy, while only 4 documented a prior response to PD-(L)1 therapy. Median duration of prior PD-(L)1 therapy was less than 6 months while the median time between last dose of prior PD-(L)1 therapy and first dose with the entinostat-pembrolizumab combination was 65 days. The median duration of response (DOR) to the entinostat-pembrolizumab combination was 4.6 months, with the longest observed response over 14 months. A total of 7 patients were on study at the time of data cut-off.

Syndax collected and analyzed blood samples of 51 of the 57 NSCLC patients enrolled. The Company evaluated the pre-treatment baseline levels of classical peripheral blood monocytes (CD14+CD16-HLA-DRhi) to identify a subset of patients that appeared to show improved clinical benefit to the entinostat-pembrolizumab combination regimen. The preliminary results showed that patients with elevated baseline levels of monocytes ("high monocyte" subset, n=14) had a confirmed ORR of 29% (4 PRs/14 patients) and a Progression Free Survival (PFS) of 5.4 months, while patients with lower baseline levels of monocytes (?low monocyte' subset, n=37) had a confirmed ORR of 5% (2 PRs/37 patients) and a PFS of 2.5 months. The overall patient population (n=57) had a PFS of 2.7 months.

On the basis of these findings, Syndax has identified a potential registration path in patients with NSCLC who have progressed on a PD(L)1 inhibitor; the trial for which is expected to start by the end of 2018.

Update on Melanoma and MSS-CRC

At the data cut-off point, a total of 6 confirmed PRs (ORR 18%; 95% CI: 6.8-34.5%) and 3 unconfirmed PRs were observed in the 34 evaluable patients in the anti-PD-1 pretreated melanoma cohort. Of these 34 patients, 16 were PD-1 refractory, and 2 had a documented response to prior anti-PD-1 therapy. A total of 22 (out of 34) patients previously received the anti-CTLA-4 antibody YERVOY® (ipilimumab) in addition to an anti-PD-1 regimen. Besides, 2 of the 3 patients with unconfirmed responses had progressive disease within 6 weeks of the scan, and the third patient discontinued due to an adverse event. The median duration of the prior anti-PD-1 therapy was less than 6 months, while the median time between the last dose of the prior anti-PD-1 therapy and the first dose with the entinostat-pembrolizumab combination was 64 days. The median DOR to the entinostat-pembrolizumab combination was 9.1 months. As on the data cut-of date, 4 out of 34 patients remained on therapy.

Syndax recently completed the enrollment for this cohort (n=55). The Company intends to continue further efficacy analyses and biomarker assessments to develop its development strategy for melanoma.

In the MSS-CRC cohort, 16 patients were initially enrolled, with a median of three lines of prior therapy in the advanced setting. However, the Company intends to expand enrollment to include a total of 37 patients in the first stage of the Simon-two stage study. Further enrollment for the modified stage 1 cohort is expected to start by the end of the second quarter, with at least three responses required to advance to the second stage, wherein 47 additional patients would be enrolled. However, the Company would announce its decision about continuing with the second stage of this cohort in the first half of 2019.

Data to Be Presented At ASCO Annual Meeting

The data from the trial would be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from June 01, 2018, to June 05, 2018, in Chicago, Illinois. The data would be presented in poster presentations with the following details:

  • Presentation titled, ?Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with non-small cell lung cancer (NSCLC) previously treated with anti-PD-(L)1 therapy', authored by Leena Gandhi, MD, PhD, NYU Perlmutter Cancer Center. It will be presented during the ?Lung Cancer-Non-Small Cell Metastatic' poster session on Sunday, June 03, 2018.
  • Presentation titled, ?Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with melanoma progressing on or after a PD-1/L1 blocking antibody', authored by Sanjiv S. Agarwala, MD, St. Luke's Hospital. It will be presented during ?Melanoma/Skin Cancers' poster session on Monday, June 04, 2018.
  • Presentation titled, ?ENCORE 601: A Phase-2 study of entinostat in combination with pembrolizumab in patients with microsatellite stable metastatic colorectal cancer', authored by Nilofer Saba Azad, MD, Sidney Kimmel Cancer Center at Johns Hopkins University. It will be presented during the ?Gastrointestinal (Colorectal) Cancer' poster session on Sunday, June 03, 2018.

Stock Performance Snapshot

May 18, 2018 - At Friday's closing bell, Syndax Pharma's stock climbed 2.21%, ending the trading session at $8.80.

Volume traded for the day: 659.64 thousand shares, which was above the 3-month average volume of 357.90 thousand shares.

Stock performance in the previous six-month period ? up 2.68%; and year-to-date - up 0.46%

After last Friday's close, Syndax Pharma's market cap was at $212.70 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.2% at the end of the session.

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