Allos Therapeutics, Inc. (NASDAQ:ALTH) today announced the
presentation of favorable survival data from the Company’s
international, randomized Phase 2b investigational study of
FOLOTYN® (pralatrexate injection) relative to erlotinib in patients
with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC).
In this study, patients receiving FOLOTYN had a 16 percent
reduction in the risk of death compared to erlotinib in the overall
(intent-to-treat) population (n=201; hazard ratio (HR)=0.84) and a
13 percent reduction in the risk of death in the primary efficacy
analysis population (n=166; HR=0.87). At six months, 56 percent of
patients treated with FOLOTYN were alive and 51 percent of patients
treated with erlotinib were alive; at one year, 28 percent of
patients treated with FOLOTYN were alive and 18 percent of patients
treated with erlotinib were alive. The median overall survival (OS)
time was 6.7 months for patients who received FOLOTYN and 7.0
months for patients who received erlotinib. The safety profile of
FOLOTYN was consistent with that observed and reported in previous
FOLOTYN solid tumor studies.
“Overall survival remains the most clinically relevant endpoint
in assessing the benefit of an investigational therapy to treat
cancer,” said Karen Kelly, M.D., an investigator of the study, The
University of Kansas Medical Center. “I believe the survival data
from this randomized Phase 2b study are compelling and warrant
exploring Phase 3 options in order to fully understand the
potential role of FOLOTYN to treat patients with advanced non-small
cell lung cancer.”
The objective of this randomized, international, multi-center
Phase 2b study (PDX-012) was to estimate the efficacy of FOLOTYN
relative to that of erlotinib as assessed by OS, the primary
endpoint of the trial. All patients had received one or two prior
systemic treatments including at least one prior platinum-based
regimen. Secondary endpoints included progression-free survival
(PFS) (HR=0.91; median PFS=3.4 months and 2.8 months for FOLOTYN
and erlotinib, respectively) and objective response rate (RR) (2
percent and 7 percent, respectively). Disease control rate (DCR),
which includes patients with complete responses, partial responses
or stable disease, was 36 percent for FOLOTYN and 43 percent for
erlotinib.
Analyses were also performed according to the statistical
analysis plan to assess the activity of FOLOTYN and erlotinib in
predefined patient cohorts. Most notably, patients with
non-squamous cell carcinoma (n=107) who received FOLOTYN
experienced a 35 percent reduction in the risk of death (OS
HR=0.65) and 42 percent reduction in the risk of disease
progression (PFS HR=0.58) relative to erlotinib. In patients with
squamous cell carcinoma, a hazard ratio for OS of 1.06 was
observed, which suggests activity of FOLOTYN given that erlotinib
has historically shown a survival benefit in these patients. In the
small subset of patients who received prior pemetrexed (n=30), a
hazard ratio for OS of 1.15 was observed.
The most common Grade 3-4 adverse event observed in patients
treated with FOLOTYN was mucositis (23 percent). Other Grade 3-4
adverse events occurring in more than five percent (but less than
10 percent) of patients were fatigue (9 percent), dyspnea (6
percent), neutropenia (6 percent), thrombocytopenia (5 percent) and
anemia (5 percent) in patients treated with FOLOTYN, and rash (8
percent), dyspnea (8 percent), anemia (8 percent) and fatigue (5
percent) in patients treated with erlotinib.
“Advanced non-small cell lung cancer is an aggressive disease.
Unfortunately, nearly all patients will progress after their
initial treatment,” said Charles Morris, MB ChB, MRCP, chief
medical officer at Allos Therapeutics. “This study is providing
Allos and the lung cancer community with important data regarding
the efficacy and safety profile for FOLOTYN in advanced NSCLC,
where there remains a high unmet medical need. We believe these
data demonstrate the clinical activity of FOLOTYN in patients with
advanced NSCLC, and we are in the process of exploring potential
Phase 3 development options for FOLOTYN in this indication.”
These data were presented in an oral presentation at the 35th
European Society of Medical Oncology (ESMO) Congress in Milan,
Italy. The company had previously announced the topline results
from this trial in July 2010.
Study Design
The objective of this randomized, open-label, international,
multi-center Phase 2b study was to estimate the efficacy of FOLOTYN
relative to that of erlotinib, marketed as TARCEVA®, as assessed by
overall survival. The trial 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 primary endpoint of the trial was overall
survival. Secondary endpoints included progression-free survival
and response rate as compared with erlotinib, and the safety and
tolerability of FOLOTYN. The study was not designed to show a
statistically significant difference between the two treatment
arms. No definition of statistical significance was included in the
statistical analysis plan.
The trial – which enrolled patients across 43 locations
worldwide (15 U.S. sites and 28 ex-U.S. sites) – was initiated by
Allos in January 2008 and completed enrollment in July 2009. The
first 35 patients enrolled in the study were randomly assigned
one-to-one to receive FOLOTYN (intravenous push on days 1 and 15 of
a 28-day cycle; initial dose of 230 mg/m2) or erlotinib (oral, 150
mg daily in a 28-day cycle). Following a protocol amendment, 166
patients were randomly assigned one-to-one to receive either
FOLOTYN at 190 mg/m2 or erlotinib at 150 mg/day and then further
stratified by light versus heavy smokers. All patients received
concurrent vitamin therapy of B12 and folic acid. According to the
statistical analysis plan, analyses were conducted to assess the
activity of FOLOTYN and erlotinib in predefined patient cohorts,
which included light smokers (n=37) and heavy smokers (n=164),
current smokers (n=50) and former smokers (n=151), squamous (n=76)
and non-squamous histology (n=107), and patients who received prior
pemetrexed (n=30) and those who had not (n=171).
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 and
non-squamous carcinomas such as 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 future 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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