Clinical Trials

* On December 6, 2015, Spectrum Pharmaceuticals  and Onxeo jointly announced the results from their Phase 1 combination trial of belinostat (Beleodaq®) with the CHOP (Cyclophosphamide, Hydroxyl-doxorubicin; Vincristine, and Prednisone) chemotherapy regimen as first-line treatment for newly diagnosed peripheral T-cell lymphoma (PTCL).  The results were presented in an oral presentation at the 57th American Society of Hematology (ASH) Annual Meeting & Exposition by Dr. Patrick Johnston, MD, PhD, Assistant Professor of Medicine at the Mayo Clinic, Rochester, MN, USA.

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". This open-label, two-part trial enrolled a total of 23 patients. Eleven were enrolled in Part A, the dose-escalation phase, to determine the study’s primary endpoint, the maximum tolerated dose (MTD). Part B of the study, the Expansion Phase, enrolled 12 additional patients at this dose level. The MTD of belinostat was established at 1,000 mg/m2 IV infusion on Days 1-5 (the recommended single agent dose) when combined with the CHOP regimen, with each component given at its full recommended dose. Secondary endpoints included safety, tolerability, Objective Response Rate (ORR: Complete Response + Partial Response), and pharmacokinetics.

Results outlined in the oral presentation showed an ORR of 86% with the belinostat and CHOP combination, based on 21 evaluable patients (18/21), with the vast majority, 67%, achieving a Complete Response (14/21), and 19% achieving a Partial Response (4/21). In addition, the belinostat and CHOP combination was shown to have an acceptable safety profile with no new or unexpected toxicities. The most common (>10%) Grade 3-4 hematologic adverse events (AEs) reported with Bel-CHOP were as expected: neutrophil count decreased (30%), anemia (22%), neutropenia (22%), white blood cell (WBC) count decreased (22%), febrile neutropenia (17%) and lymphocyte count decreased (17%). No Grade 3-4 non-hematologic AEs >10% were reported. No patient discontinued therapy due to AEs. One patient died as a result of disease progression during the study.

These Phase 1 study results indicate that the combination of belinostat and CHOP is a potentially viable treatment option. Onxeo and Spectrum now look forward to further evaluating the combination in a Phase 3 trial.

* On November 9, 2015, Onxeo 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 57th 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) 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.
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)
* On July 23, 2014, BioAlliance Pharma and Topotarget announced that the cross-border merger between the two companies is legally effective as of 22 July 2014 to create Onxeo, dedicated to orphan oncology diseases.