Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois, as part of the ASCO proceedings.
Shown below is the summary abstract on the currently enrolling pivotal, registrational PTCL trial being conducted under a Special Protocol Assessment, that is now available for viewing on the ASCO.org website (www.asco.org).
A Multicenter, Open-Label Trial of Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
- Owen A. O'Connor - NYU Cancer Institute, New York, NY
- Pier Luigi Zinzani - University of Bologna, Bologna, Italy
The study is a global, multicenter, single arm efficacy and safety study of belinostat monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who failed at least one prior systemic therapy. Main aims are to determine objective response rate and time-related response parameters.
Belinostat is a hydroxamate, class I & II histone deacetylase inhibitor (HDACi). Pre-clinically, belinostat has a broad antineoplastic spectrum at sub-micromolar concentrations including T-cell lymphoma lines. Phase 1 and 2 trials are ongoing in multiple indications and in more than 500 patients. Belinostat treatment was safe and well tolerated, and the most common events included nausea, fatigue, and vomiting. A Phase 2 study of belinostat monotherapy in relapsed/refractory PTCL demonstrated in 19 evaluable patients an objective response rate of 32% and a median response duration of 268+ days. The results led to the present pivotal trial in PTCL as agreed with FDA under a Special Protocol Assessment.
Eligible patients have received at least one prior systemic chemotherapy and have histologically confirmed diagnosis of PTCL of one of the subtypes:
- Anaplastic large cell lymphoma (ALK-positive or negative)
- ALK-negative
- Angioimmunoblastic T-cell lymphoma
- Enteropathy-associated T-cell lymphoma
- Extranodal NK/T-cell lymphoma
- Nasal type
- Hepatosplenic T-cell lymphoma
- Peripheral T-cell lymphoma
- Not otherwise specified (NOS) or
- Subcutaneous panniculitis-like T-cell Lymphoma
The diagnosis should be confirmed by a positive set of T-cell markers and negativity of B-cell markers. A pathology panel will review all diagnosis specimens.
Belinostat will be administered as a 30-minute IV infusion of 1000 mg/m2 on days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
As of January 4, 2010, 19 patients have been included in the trial. The primary study endpoint is objective response rate (ORR). The sample size was based on a 2-stage optimal design with a hypothesized ORR ofuninteresting" ORR of>
Pharmacokinetic data will be collected to explore exposure-response relationships.
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