Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that
results from the Phase 2b investigational trial of FOLOTYN®
(pralatrexate injection) versus erlotinib in patients with Stage
IIIB/IV (advanced) non-small cell lung cancer (NSCLC) will be
presented at the 35th European Society of Medical Oncology (ESMO)
Congress — Milan, Italy from October 8-12, 2010.
"This is the first time that Allos will have an opportunity to
present the results from the Phase 2b trial of FOLOTYN in patients
with advanced non-small cell lung cancer,” said Charles Morris, MB
ChB, MRCP, chief medical officer at Allos Therapeutics. “We believe
these are important results for the cancer community – generating
data on the efficacy and safety profile for FOLOTYN in this
treatment setting where there remains a high unmet need – and are
pleased that the ESMO Congress has accepted these data as a
late-breaking abstract to be highlighted in an oral
presentation.”
The 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.
Presentation details are as follows:
Presentation Date/Time: Monday, October 11, 13:15 – 14:30
CESTPoster Title: “Randomized Phase 2b Study of Pralatrexate
vs Erlotinib in Patients with Stage IIIB/IV Non-small Cell Lung
Cancer (NSCLC) after Failure of Prior Platinum-Based
Therapy”First Author: K. Kelly, University of Kansas, Kansas
City/USAbstract Number: LBA17Location: Chest tumors
II, Gold Hall
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
over 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 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.
Adverse Reactions:
The most common adverse reactions observed were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events were 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/sulfamethaxazole) may result
in delayed renal clearance.
For additional important safety information, please see the full
prescribing information for FOLOTYN at www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements regarding the potential safety and
efficacy of FOLOTYN for the treatment of patients with advanced
non-small cell lung cancer, the potential development of FOLOTYN
for the treatment of advanced non-small cell lung cancer; and other
statements that are other than statements of historical facts. In
some cases, you can identify forward-looking statements by
terminology such as “may,” “will,” “should,” “expects,” “intends,”
“plans,” anticipates,” “believes,” “estimates,” “predicts,”
“projects,” “potential,” “continue,” and other similar terminology
or the negative of these terms, but their absence does not mean
that a particular statement is not forward-looking. Such
forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that may cause actual
results to differ materially from those anticipated by the
forward-looking statements. These risks and uncertainties include,
among others: that data from preclinical studies and clinical
trials may not necessarily be indicative of future clinical trial
results; that the safety and/or efficacy profile for FOLOTYN may
not support further clinical development in advanced non-small cell
lung cancer; and the risk that the Company may lack the financial
resources and access to capital to fund future clinical trials for
FOLOTYN. Additional information concerning these and other factors
that may cause actual results to differ materially from those
anticipated in the forward-looking statements is contained in the
"Risk Factors" section of the Company's Quarterly Report on Form
10-Q for the quarter ended June 30, 2010, and in the Company's
other periodic reports and filings with the Securities and Exchange
Commission. The Company cautions investors not to place undue
reliance on the forward-looking statements contained in this press
release. All forward-looking statements are based on information
currently available to the Company on the date hereof, and the
Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this presentation, except as required by law.
Note: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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