Initial data from COMPLETE study on peripheral T-cell lymphoma presented at ICML 2011

Jun 16 2011

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced the presentation of initial data from COMPLETE, an international registry designed to address the urgent need for an increased understanding of the treatment patterns and outcomes for patients with peripheral T-cell lymphoma (PTCL). The registry, supported by Allos Therapeutics, Inc., is guided by a prestigious multi-disciplinary steering committee. Data were presented in a poster presentation at the 11^th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (June 15-18) by Dr. Francine Foss.

PTCL is a biologically diverse group of aggressive, mature T and NK (natural killer) cell non-Hodgkin lymphomas with similar outcomes, which include PTCL-NOS (PTCL not otherwise specified), AITL (angioimmunoblastic T-cell lymphoma), and ALCL (anaplastic large-cell lymphoma). The prognosis for patients with PTCL is generally poor for most subtypes.

"These data from COMPLETE represent a first step toward increasing the understanding of peripheral T-cell lymphoma - where, although progress has been made in the treatment of this disease, there remains a high unmet need to further understand this complicated and rare group of non-Hodgkin lymphomas," explained Francine Foss, M.D., Professor of Medicine, Hematology, at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, and chair of the COMPLETE International Steering Committee. "Registries, such as COMPLETE, can be invaluable in providing 'real-world' data that ultimately increase the community's understanding of how specific patient populations are being treated as well as the outcomes of treatment - both in routine clinical practice and in clinical trials."

COMPLETE - a prospective, longitudinal, multinational, observational study - is collecting data on how patients with PTCL are treated across practice settings and is expected to provide, for the first time, important and detailed information on PTCL disease management across various treatment regimens, including systemic therapy, stem cell transplant, and radiation therapy. The registry is enrolling patients with newly-diagnosed PTCL.

At the time of presentation, 59 sites had been activated and 98 patients enrolled - for which baseline and treatment records have been locked for 74 and 26 patients, respectively. Baseline characteristics presented at ICML show the average patient age to be 58 years with slightly more men enrolled in the registry to date [44 men (59%) and 30 female (41%)]; the most common PTCL subtypes are PTCL-NOS (18 of 74 patients; 24%), ALCL (13 of 74 patients; 18%), AITL (11 of 74 patients; 15%), T/NK cell lymphoma, nasal type (7 of 74 patients; 10 %), and transformed mycosis fungoides (7 of 74 patients; 10%). Treatment records show the most common initial treatment to be induction chemotherapy alone (17 of 26 patients; 65%).

Updated data obtained from the registry will be presented at future scientific meetings and published in peer-reviewed journals.

"With rare diseases, the medical community often has limited access to information about treatment patterns and outcomes. COMPLETE is unique in that it is the first registry designed to characterize treatment patterns across practice settings in the United States and Europe for patients with peripheral T-cell lymphoma," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "As a company focused on increasing overall disease-state awareness and treating patients with relapsed or refractory peripheral T-cell lymphoma, our hope is that COMPLETE will provide important answers for the broader hematology community, as well as inform the development and implementation of future studies."