Beleodaq® (belinostat) pivotal BELIEF study results published in the Journal of Clinical Oncology (JCO)

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced the publication of results from the pivotal BELIEF (PXD101-CLN-19) study which was selected as a Rapid Communication in the Journal of Clinical Oncology (JCO), the journal of the American Society of Clinical Oncology.  The JCO is peer-reviewed and is one of the most recognized, selective, and specialized journals within oncology.

The study, led by Dr. Owen O’Connor from the Center for Lymphoid Malignancies, Department of Medicine, Columbia University Medical Center, New York, USA, showed that monotherapy with Beleodaq® (belinostat) produced complete and durable responses with manageable toxicity in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) across the major subtypes, irrespective of the number or type of prior therapies.

Beleodaq® is a histone deacetylase (HDAC) inhibitor indicated for the treatment of patients with R/R PTCL. This indication was approved by the US Food and Drug Administration (FDA) in July 2014 based on tumor response rate and duration of response (DOR). A confirmatory trial is in preparation to assess Beleodaq®’s efficacy and safety in PTCL in the 1st line of treatment in combination with CHOP (Cyclophosphamide, Hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and Prednisone) standard protocol.

We are honored to have the pivotal Beleodaq® study results selected as a Rapid Communication in the prominent Journal of Clinical Oncology. This is a highly distinguished category that the JCO reserves for papers judged to have great impact to their broad clinical readership and we at Onxeo are delighted for Beleodaq® to be given this recognition”, comments Judith Greciet, CEO of Onxeo.

This is a very exciting time in the treatment of patients with PTCL”, said Dr. Owen A. O'Connor, MD, PhD, Director of the Center for Lymphoid Malignancies, Professor of Medicine and Experimental Therapeutics at Columbia Medical Center, New York Presbyterian Medical Center, one of the lead investigators in the BELIEF study. “At long last we finally have tools in the therapeutic armamentarium to help our patients. Belinostat represents the latest new drug approved for patients with R/R PTCL that has relatively few side effects and produces long durations of benefit, even in patients who have received multiple conventional treatments in the past. Now that we have several new options to treat the disease when it comes back, we need to use these drugs to make better up-front treatment platforms; Belinostat will be an important part of that future.

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