Drugs / Entinostat
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News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-04-30 | Taizhou EOC Pharma Co., Ltd. | Regulatory 亿腾景昂1类创新药恩替司他片获批上市 eocpharma.com ↗
2024年4月24日，由亿腾景昂开发的1类创新药——恩替司他片（商品名：景助达）新药上市申请获国家药品监督管理局（NMPA）正式批准，适应症为 联合芳香化酶抑制剂用于治疗激素受体（HR）阳性、人类表皮生长因子受体-2（HER-2）阴性，经内分泌治疗复发或进展的局部晚期或转移性乳腺癌患者。 |
| 2021-12-08 | Taizhou EOC Pharma Co., Ltd. | Results 亿腾景昂1类新药III期临床研究入选第44届SABCS eocpharma.com ↗
结果显示，恩替诺特联合依西美坦治疗可显著改善激素受体阳性乳腺癌患者无进展生存期，在客观应答率和疾病控制率等方面优于依西美坦单药治疗，且患者安全性和耐受性良好。 |
| 2021-11-20 | Taizhou EOC Pharma Co., Ltd. | Results 亿腾景昂临床III期研究成果入选第44届圣安东尼奥乳腺癌大会（SABCS） eocpharma.com ↗
结果显示，恩替诺特联合依西美坦对比安慰剂联合依西美坦可以显著改善经内分泌治疗失败的HR阳性、HER-2阴性晚期乳腺癌患者的PFS，差异具有统计学显著性，且患者安全性和耐受性良好。 |
| 2020-05-21 | Syndax Pharmaceuticals | Results ECOG-ACRIN Provides Syndax Pharmaceuticals With Results of Phase 3 E2112 Trial of Entinostat Plus Exemestane in Patients with HR+, HER2- Breast Cancer syndax.com ↗
The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival (OS) benefit over hormone therapy alone. |
| 2019-04-01 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Presents Updated Phase 2 Data from ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) at the American Association for Cancer Research 2019 Annual Meeting syndax.com ↗
During an oral presentation today titled, "Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with melanoma previously treated with anti-PD1 therapy", Ryan J. Sullivan M.D ., Assistant Professor, Hematology/Oncology, Massachusetts General Hospital , presented results from the ENCORE 601 melanoma cohort that enrolled patients whose disease had progressed on or after anti-PD-1 therapy. |
| 2019-03-07 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports Fourth Quarter 2018 Financial Results and Provides Clinical and Business Update syndax.com ↗
Syndax also today announced that both ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech's PD-(L)1 inhibitor, TECENTRIQ ® (atezolizumab), in patients with triple negative breast cancer (TNBC), and ENCORE 603, the Phase 1b/2 trial evaluating entinostat in combination with BAVENCIO ® (avelumab), an anti-PD-(L)1 co-developed and co-commercialized by Merck KGaA Darmstadt, Germany and Pfizer, in patients with ovarian cancer, failed to meet their respective primary endpoints of demonstrating an improvement in progression free survival (PFS). |
| 2018-10-25 | Syndax Pharmaceuticals | Results 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 syndax.com ↗
The trial did not achieve the statistical hurdle for the first primary endpoint of improving progression-free survival (PFS) that would have provided the earliest regulatory filing opportunity. |
| 2018-09-24 | Syndax Pharmaceuticals | Results Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Non-Small Cell Lung Cancer syndax.com ↗
Updated biomarker analyses continue to support prior observation of enhanced clinical benefit in subpopulation of patients with elevated baseline levels of peripheral classical blood monocytes; 5.3 month PFS and 21% ORR observed in subpopulation |
| 2018-05-17 | Syndax Pharmaceuticals | Results Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) syndax.com ↗
Confirmed objective responses with the combination regimen have been observed across all cohorts. |
| 2017-11-11 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Presentation of Data from Immuno-oncology Clinical Trials at the Society for Immunotherapy of Cancer 32nd Annual Scientific Meeting syndax.com ↗
The observed overall response rate was 10% (95% CI: 2%-26%) in patients who had progressed on prior anti-PD-1 or PD-(L)1 therapy and 24% (95% CI: 7%-50%) in patients naïve to PD-1 or PD-(L)1 therapy. |
| 2017-07-11 | Syndax Pharmaceuticals | Results Preclinical Results Support Entinostat's Role in Targeting the Tumor Microenvironment to Enhance Immune Checkpoint Therapy syndax.com ↗
The results indicated that entinostat has an inhibitory effect on MDSC immunosuppressive function both in vivo and in vitro , which results in enhanced anti-tumor activity of the combination. |
| 2017-05-17 | Syndax Pharmaceuticals | Results Syndax Announces Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Melanoma syndax.com ↗
Data from the first cohort of patients indicate that 4 patients achieved an objective response (ORR) by irRECIST criteria (3 patients had a confirmed response; 1 patient had an unconfirmed response; 31% ORR, 95% CI: 9 — 61%). |
| 2017-05-16 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Advancement of ENCORE 601 in Non-Small Cell Lung Cancer Patients with Disease Progression on or After PD-1 Therapies syndax.com ↗
The cohort of NSCLC patients who had previously progressed on PD-1 or PD-L1 will now re-open and enroll a total of 56 patients. |
| 2017-03-02 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports Fourth Quarter and Year-end 2016 Financial Results and Provides Clinical and Business Update syndax.com ↗
The trial will now enroll an additional 21 patients, with accrual targeted to be completed by the end of the fourth quarter of this year. |
All press releases naming this drug 29 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 77 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | entinostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03215264 ↗ |
| Known as | MS-27-275 | ChEMBL registry synonym — accepted as the source's own label CHEMBL27759 ↗ |
| Known as | MS-275-27 | ChEMBL registry synonym — accepted as the source's own label CHEMBL27759 ↗ |
| Known as | SNDX-275 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00754312 ↗ |
| Action | Inhibit | “MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.” NCT00098891 ↗ |
| Modality | Small molecule | “The benzamide derivative entinostat inhibits histone deacetylase and induces histone hyperacetylation.” PMID 34563945 ↗ Sep 2021 |
| Route | Oral | “Given orally” NCT00098891 ↗ |
| Target | HDAC1 | “Entinostat is an oral HDAC inhibitor that selectively inhibits class I (primarily HDAC1 and HDAC3) and class IV HDACs.” NCT07492394 ↗ |
| Target | HDAC3 | “Entinostat is an oral HDAC inhibitor that selectively inhibits class I (primarily HDAC1 and HDAC3) and class IV HDACs.” NCT07492394 ↗ |