Syndax announces data from entinostat phase 2 study on HL

Syndax Pharmaceuticals, Inc. announced today that data from ENGAGE 501, a multicenter, phase 2 study, demonstrated entinostat, a novel, oral small molecule inhibitor of class I histone deacetylases, showed activity as a single agent in patients with relapsed or refractory Hodgkin's lymphoma (HL).  This data is being presented today, December 11, from 6:00 to 8:00 PM PT at the American Society of Hematology Annual Meeting and Exposition in San Diego.  

"Showing activity in this hard-to-treat patient population, demonstrates potential for entinostat to treat Hodgkin's lymphoma," said Anas Younes, MD, professor, department of lymphoma/myeloma, division of cancer medicine, The University of Texas MD Anderson Cancer Center. "These results are consistent with what has been seen with other HDAC inhibitors with a lower rate of toxicity warranting further study of entinostat particularly in combination strategies and at an earlier stage of disease."

Highlights of the data include:

• Antitumor activity observed in HL patients progressing after SCT with bulky disease in about a third of patients within two cycles of therapy
• Progression-free survival (PFS) showed durable responses in bulky disease patients
• Overall survival (OS) was an exploratory endpoint with data that is still maturing
• Entinostat was well tolerated and the safety profile is consistent with previous studies allowing for future combination treatments.

"We are pleased to see that the results of ENGAGE 501 provide evidence of single-agent activity for entinostat in Hodgkin's lymphoma," said Joanna Horobin, MD, president and chief executive officer of Syndax.  "Given this data combined with the recently reported ENCORE 301 breast cancer and the ENCORE 401 NSCLC data, we are enthusiastic about the potential to improve outcomes in both solid tumors and hematological malignancies."American Society of Hematology Annual Meeting and ExpositionDetails on the ENGAGE 501 presentation and additional data presentations are below:

Presentation Date/Time: Sunday, December 11 from 6:00 PM - 8:00 PM
Poster Title: The HDAC Inhibitor Entinostat (SNDX-275) Induces Clinical Responses in Patients with Relapsed and Refractory Hodgkin's Lymphoma: Results of ENGAGE-501 Multicenter Phase 2 Study 
Program/Session: Oral and Poster Abstracts, 624. Lymphoma- Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster Abstract Number: 2715
Location: Hall GH (San Diego Convention Center)

Presentation Date/Time: Saturday, December 10, 2011: 5:30 PM-7:30 PM
Poster Title: HDAC and LSD1 Inhibitors Synergize to Induce Cell Death in Acute Leukemia Cells
Program/Session: Oral and Poster Abstracts, 604. Molecular Pharmacology, Drug Resistance: Poster I
Abstract Number: 1427
Location: Hall GH (San Diego Convention Center)

Presentation Date/Time: Monday, December 12 from 6:00 PM - 8:00 PM
Poster Title: Entinostat, a Novel Histone Deacetylase (HiDAC) Inhibitor Enhances the Anti-Tumor Activity of Bortezomib (BTZ) in Rituximab-Chemotherapy Sensitive and Resistant Lymphoma Cell Lines
Program/Session: Oral and Poster Abstracts, 625. Lymphoma - Pre-Clinical - Chemotherapy and Biologic Agents: Poster III
Abstract Number: 3734
Location: Hall GH (San Diego Convention Center)