FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Jan 20 2011

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the Journal of Clinical Oncology has published data from the Company's pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN^® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). These published results are from an updated analysis of the PROPEL study, which was the basis of the September 2009 U.S. Food and Drug Administration (FDA) accelerated approval of FOLOTYN - the only single-agent approved for the treatment of patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.

“Data from PROPEL demonstrate the role of FOLOTYN as a single-agent treatment for patients with peripheral T-cell lymphoma whose disease is no longer responding to initial chemotherapy”

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). PTCL is often initially treated with multi-agent systemic chemotherapy; however, the majority of patients ultimately develop relapsed or refractory disease. The prognosis for patients with PTCL is generally poor for most subtypes.

"Data from PROPEL demonstrate the role of FOLOTYN as a single-agent treatment for patients with peripheral T-cell lymphoma whose disease is no longer responding to initial chemotherapy," said Owen A. O'Connor, M.D., Ph.D., principle investigator in the PROPEL study of FOLOTYN; deputy director for Clinical Research and Cancer Treatment, NYU Cancer Institute; chief, Division of Hematologic Malignancies and Medical Oncology; professor of Medicine and Pharmacology at the NYU Langone Medical Center. "Although patients enrolled in this trial received a median of three - and up to 12 - prior therapies, it is particularly impressive that we still observed a compelling overall response rate, with durable responses - an important measure of activity for this agent."

Results of the published PROPEL (Pralatrexate in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma) study show an overall response rate (complete response (CR), complete response unconfirmed (CRu), and partial response (PR)) of 29 percent).

As assessed by the independent central review, of the 69 patients who did not have any evidence of response to their most recent prior therapy, 25 percent>2 once weekly by IV push over 3-5 minutes for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity.

The most common Grade 3-4 adverse events observed were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%). See below for Important Safety Information.

"As the only treatment approved for patients with relapsed or refractory peripheral T-cell lymphoma, FOLOTYN is an important addition to the treatment paradigm for this aggressive form of T-cell lymphoma," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "The strength of the results from the pivotal PROPEL study add to the growing body of data demonstrating that FOLOTYN is an effective treatment option for patients with relapsed or refractory peripheral T-cell lymphoma. As part of our ongoing commitment to the medical community and patients, we are exploring the potential of FOLOTYN as a single-agent and in combination with other therapies in a variety of hematologic malignancies, including first-line PTCL and relapsed or refractory cutaneous T-cell lymphoma."