Allos Therapeutics Announces FOLOTYN® Data to Be Presented as a Late Breaker at the 2010 Chicago Multidisciplinary Symposium...
01 12월 2010 - 10:00PM
Business Wire
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, MDAbstract
Number: LBOA2, Oral Abstract Session IIILocation:
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.
About FOLOTYN
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 www.allos.com.
IMPORTANT SAFETY INFORMATION
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
www.FOLOTYN.com.
Note: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.
Source: Allos Therapeutics, Inc.
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