Full results to be reported in Oral Presentation at 2015 ASH (American Society of Hematology) Annual Meeting

• Data demonstrate 89% objective response rate, 72% complete response rate, and good safety profile of belinostat in combination with CHOP
• Study supports the interest of belinostat in combination with CHOP as first-line treatment for PTCL

Paris (France), Copenhagen (Denmark) – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, announced the initial results from its Phase 1 trial of belinostat, its potent, pan-HDAC (histone deacetylase) inhibitor, in combination with CHOP chemotherapy regimen as first-line treatment in patients with peripheral T-cell lymphoma (PTCL).  The Bel-CHOP combination has demonstrated to be well-tolerated with all components of belinostat and CHOP given at their approved therapeutic doses. Furthermore, the efficacy data indicate that the combination is a promising new regimen in PTCL that Onxeo together with its partner Spectrum Pharmaceuticals will further evaluate in a Phase 3 randomized trial, planned to begin in 2016.

The abstract has been accepted for oral presentation at the 57^th American Society of Hematology (ASH) Annual Meeting & Exposition, being held December 5-8 in Orlando, FL, USA.

The open-label, randomized, two-part trial enrolled a total of 23 patients, of which 11 were enrolled in the dose-escalation Part A to determine the study’s primary endpoint, the maximum tolerated dose (MTD), followed by 12 patients treated in Part B at this dose level. The MTD dose was established at 1000 mg/m² IV infusion on days 1-5.

Secondary endpoints included safety, tolerability, and objective response rate (ORR: Complete response + partial response) and pharmacokinetics.

Results outlined in the accepted abstract (#253)¹ demonstrated an objective response rate of 89% based on 18 evaluable patients (16/18), with the vast majority, 72%, achieving a complete response (13/18) and 17% achieving a partial response (3/18). In addition, the combination was shown to have a manageable safety profile with rates of adverse events consistent with those typically reported with CHOP alone.

Graham Dixon, PhD, Chief Scientific Officer of Onxeo, commented, “Currently, CHOP chemotherapy regimens are recommended for first-line treatment of PTCL, however the prognosis remains poor for many patients who relapse within five years, signifying that improved treatment strategies are still very much needed to produce better outcomes for these patients. This trial confirms that the potential is high for a synergistic effect of a Bel-CHOP combination treatment regimen for patients with PTCL and the initial results showing 72% of patients achieved disappearance of all signs of cancer are very promising.”

Judith Greciet, Chief Executive Officer of Onxeo, added, “Belinostat was approved in the U.S for the second-line treatment of patients with relapsed or refractory PTCL based on results from our pivotal Phase 2 BELIEF study, which demonstrated tolerability and durable clinical benefit of the drug as a single-agent.  The findings we will present at the ASH Annual Meeting go well beyond this and indicate that the combination of belinostat and CHOP therapy as first-line treatment generates a highly potent effect compared to the current CHOP regimen alone. Beyond expanding the potential of Belinostat from second- to first-line treatment of PTCL, this study confirms the validity of combining this drug with other therapies for improved outcomes.”

Logistical details for the Oral Presentation at the ASH Annual Meeting are as follows:

Abstract #253: Safe and Effective Treatment of Patients with Peripheral T-cell Lymphoma (PTCL) with the Novel HDAC Inhibitor, Belinostat, in Combination with CHOP: Results of the Bel-CHOP Phase 1 Trial

Presenting Author: Patrick B. Johnston, MD, PhD (Mayo Clinic, Rochester, USA)

Oral Session Name: 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: NHL – New Drugs

Session Date and time: Sunday, December 6, 2015

Presentation Time: 12:00 p.m. ET

Location, Room: Orange County Convention Center, W311

The ASH Annual Meeting is the world’s premier event in malignant and non-malignant hematology. The meeting provides an invaluable educational experience and an opportunity to review thousands of scientific abstracts highlighting updates in the hottest topics in hematology.

151109EN_ASH Abstract