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Allos Therapeutics Announces FOLOTYN Data to Be Presented as a Late Breaker at the 2010 Chicago Multidisciplinary Symposium in Thoracic Oncology

WESTMINSTER, Colo.--(BUSINESS WIRE)--Dec 1, 2010 - Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that further analyses from the Company's Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) compared to erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the 2010 Chicago Multidisciplinary Symposium in Thoracic Oncology. This meeting will be held December 9-11 in Chicago, Illinois and is co-sponsored by the American Society of Clinical Oncology (ASCO), American Society for Radiation Oncology (ASTRO), International Association for the Study of Lung Cancer (IASLC), and the University of Chicago.

“Allos is pleased that this abstract was accepted for oral presentation at one of the premier lung cancer conferences,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. “We look forward to sharing the full results from this important study with the lung cancer community in December.”

Presentation details are as follows:

Abstract Title: “Randomized Study of Pralatrexate vs Erlotinib in 2nd- and 3rd-Line Advanced Non-Small Cell Lung Cancer (NSCLC): Results in Subgroups and Factors Affecting Outcome”
First Author: Karen Kelly, MD
Abstract Number: LBOA2, Oral Abstract Session III
Location: International Ballroom (Hilton Chicago)
Presentation Date/Time: Friday, December 10, 2:15-3:15 p.m.

This randomized, open-label, international, multi-center Phase 2b study comparing FOLOTYN versus erlotinib, marketed as TARCEVA®, enrolled 201 current or former smokers with Stage IIIB/IV (advanced) NSCLC who had received one or two previous treatments, including at least one prior platinum-based chemotherapy regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival and response rate, both compared to erlotinib, and the safety and tolerability of FOLOTYN.

About Lung Cancer

More people die each year from lung cancer than any other type of cancer – including breast, prostate and colorectal cancers combined. In 2010, it is estimated that there will be more than 200,000 new cases of lung cancer diagnosed in the United States and more than 150,000 deaths. There are primarily two types of lung cancer: NSCLC and small cell lung cancer (SCLC). NSCLC accounts for the majority of lung cancers (about 87 percent) and develops slowly – often causing few or no symptoms until very late stages. The most common subtypes of NSCLC are squamous cell carcinoma, adenocarcinoma and large-cell undifferentiated carcinoma; squamous cell carcinomas account for 25-30 percent of all lung cancers while adenocarcinoma and large-cell undifferentiated carcinoma account for 40 percent and 10-15 percent of lung cancers, respectively. The majority of people are diagnosed with advanced stage disease and only one to five percent of people with advanced stage (IIIB/IV) NSCLC survive to five years. The most widely used therapies to date remain surgery, chemotherapy and radiation therapy.


FOLOTYN, a folate analogue metabolic inhibitor, was discovered by Sloan-Kettering Institute for Cancer Research, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent 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. FOLOTYN has been available to patients in the U.S. since October 2009.

About Allos Therapeutics

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN® (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Allos is also developing FOLOTYN in other hematologic malignancies and solid tumors. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, CO. For additional information, please visit


Warnings and Precautions

FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.

Mucositis may occur. If ‰¥Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.

FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.

Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.

Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ‰¥Grade 3, omit or modify dose.

Dermatologic reactions may occur. Patients with dermatologic reactions should be monitored closely, and if skin reactions are severe, FOLOTYN should be withheld or discontinued.

Adverse Reactions

The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Use in Specific Patient Population

Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Drug Interactions

Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance.

Please see FOLOTYN Full Prescribing Information at

Note: The Allos logo and FOLOTYN name are trademarks of Allos Therapeutics, Inc.

Source: Allos Therapeutics, Inc.


Contact: Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
Madeline Malia, 609-454-0325



Posted: December 2010