Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported updated
data from the Company�s pivotal Phase 2 PROPEL study of
pralatrexate in patients with relapsed or refractory peripheral
T-cell lymphoma (PTCL). The overall response rate for pralatrexate
as evaluated by central independent oncology review using
International Workshop Criteria (IWC) was 28% (30 of 109 evaluable
patients) with a median duration of response of 9.4 months, or 287
days. Of the 30 patients who responded to pralatraxate, 21 patients
(70%) did so after cycle one of therapy. Median overall survival
was 14.7 months, with 57% of responders surviving 12 months or
more. The most common Grade 3/4 adverse events were
thrombocytopenia, mucositis, neutropenia, and anemia, which were
manageable.
�The overall response rate and duration of response continue to
be very encouraging in these very heavily pretreated patients with
peripheral T-cell lymphoma,� said Owen O�Connor, M.D., director of
the Lymphoid Development and Malignancy Program and chief of the
Lymphoma Service at the Herbert Irving Comprehensive Cancer Center
at New York-Presbyterian Hospital/Columbia University Medical
Center and principal investigator of the PROPEL study. �PTCL is a
type of lymphoma that typically has a worse prognosis compared to
B-cell lymphoma, and is generally less responsive to traditional
combination chemotherapy regimens. To my knowledge, the PROPEL
study is the largest prospective study of its type ever conducted
in patients with relapsed or refractory PTCL. Based on these
promising data from the PROPEL study, I believe, if approved,
pralatrexate has the potential to play a clinically meaningful role
in the treatment of patients with relapsed or refractory PTCL.�
The Company recently announced that the U.S. Food and Drug
Administration (FDA) accepted its New Drug Application (NDA) for
pralatrexate for priority review and established a Prescription
Drug User Fee Act date of September 24, 2009 for a decision
regarding approval of the NDA. (See Allos press release dated May
26, 2009).
PROPEL Study Results
The results presented at the 45th American Society of Clinical
Oncology (ASCO) Annual Meeting in a poster titled �PROPEL: Results
of the Pivotal, Multi-center, Phase 2 Study of Pralatrexate in
Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
(PTCL)� are as follows:
Best Response by Independent Central Review �
N = 109
Overall response rate (CR+CRu+PR): � 30 (28%) Complete
response/Complete response unconfirmed (CR/CRu) � 10 (9%) Partial
response (PR) � 20 (18%) Stable disease (SD) � 23 (21%) Median
duration of response � 9.4 months (287 days) Mean duration of
treatment for all responders � 234 days Disease control rate
(CR+CRu+PR+SD) � 49% Median overall survival � 14.7 months
Median duration of response was 9.4 months, with 7 responses
exceeding 300 days, demonstrating the durability of response to
pralatrexate therapy. In addition, 4 responding patients went on to
definitive therapy with stem cell transplant. Notably, 17 of 69
patients who did not have evidence of response to their last prior
treatment and 5 of 26 who did not have evidence of response to any
prior treatments, responded to pralatrexate. PROPEL patients
received a median of 3 prior systemic treatment regimens (range of
1-12), including 18 patients who had previously undergone an
autologous stem cell transplant. Responses were also assessed by
the PROPEL investigators, who determined that 42 of 109 evaluable
patients, or 39%, achieved a response. Of these, 19 patients had a
CR/CRu, 23 patients had a PR and 22 patients had stable
disease.
The most common grade 3/4 adverse events were thrombocytopenia,
which was observed in 32% of patients; mucositis in 22% of
patients; neutropenia in 20% of patients; and anemia in 17% of
patients. Twenty-six patients discontinued pralatrexate due to
adverse events, most frequently mucositis (6%) or thrombocytopenia
(5%).
�PTCL is an extremely challenging disease, and one for which
there are currently no FDA-approved therapies,� commented Pablo J.
Cagnoni, chief medical officer of Allos Therapeutics, Inc. �The
data from the PROPEL study suggest that pralatrexate may be an
effective treatment option for patients with relapsed or refractory
PTCL, including those with disease that has been unresponsive to
prior therapy. Our NDA for this patient population has been
accepted for priority review and we look forward to working with
the FDA through the review process to bring this product to
market.�
PROPEL Study Design and Endpoints
PROPEL is a pivotal Phase 2 international, multi-center,
open-label, single-arm study evaluating pralatrexate for the
treatment of patients with relapsed or refractory PTCL. PROPEL
enrolled a total of 115 patients, 109 of whom are considered
evaluable for response according to the study protocol. To be
eligible for the study, patients� disease must have progressed
after at least one prior treatment.
Patients were considered evaluable if they received at least one
dose of pralatrexate and their diagnosis of PTCL was confirmed by
independent pathology review. Patients received 30 mg/m2 of
pralatrexate intravenously once every week for six weeks followed
by one week of rest per cycle of treatment. Patients also received
vitamin B12 and folic acid supplementation. The primary endpoint of
the study is objective response rate, as assessed by central
independent oncology review using IWC. Duration of response is the
key secondary endpoint. Overall survival, progression free survival
and safety and tolerability were also assessed.
The PROPEL study was conducted under an agreement reached with
the FDA under its Special Protocol Assessment, or SPA, process. The
SPA process allows for FDA evaluation of a clinical study protocol
intended to form the primary basis of an efficacy claim in support
of an NDA, and provides an agreement that the study design,
including study size, clinical endpoints and/or data analyses are
acceptable to the FDA. The response rate, duration of response and
safety profile required to support FDA approval are not specified
in the PROPEL study protocol and will be subject to FDA review.
About Peripheral T-cell Lymphoma
PTCL comprises a heterogeneous group of aggressive mature T- and
NK-cell lymphomas that accounts for approximately 10% to 15% of new
non-Hodgkin�s lymphoma (NHL) cases per year in the U.S. The
American Cancer Society estimates that 66,000 new cases of NHL will
be diagnosed in the U.S. in 2009. The Company estimates the current
annual prevalence of PTCL in the U.S. to be approximately 9,500
patients. No pharmaceutical agents are currently approved for use
in the treatment of either first-line or relapsed or refractory
PTCL. In addition to those PTCL patients who do not respond to
first-line treatment, a significant number of first-line
multi-agent chemotherapy responders relapse or become refractory
after treatment. According to the clinical literature, patients
with aggressive PTCL have an overall five-year survival rate of
only approximately 25% after first-line therapy.
About Pralatrexate
Pralatrexate is a targeted antifolate designed to accumulate
preferentially in cancer cells. Based on preclinical studies, the
Company believes that pralatrexate selectively enters cells
expressing RFC-1, a protein that is over expressed on certain
cancer cells compared to normal cells. Once inside cancer cells,
pralatrexate is efficiently polyglutamylated, which leads to high
intracellular drug retention. Polyglutamylated pralatrexate
essentially becomes �trapped� inside cancer cells, making it less
susceptible to efflux-based drug resistance. Acting on the folate
pathway, pralatrexate interferes with DNA synthesis and triggers
cancer cell death.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on
developing and commercializing innovative small molecule drugs for
the treatment of cancer. The Company�s product candidate,
pralatrexate, is a targeted antifolate designed to accumulate
preferentially in cancer cells. In March 2009, the Company
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for approval to market pralatrexate for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma. In May 2009, the FDA accepted the Company�s NDA for
priority review and established a Prescription Drug User Fee Act
date of September 24, 2009 for a decision regarding approval of the
NDA. In addition, pralatrexate is being evaluated in patients with
non-small cell lung cancer, bladder cancer and a range of lymphoma
sub-types. Allos currently retains exclusive worldwide rights to
pralatrexate for all indications. For more information about Allos,
visit 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 for
pralatrexate to play a clinically meaningful role in the treatment
of patients with relapsed or refractory PTCL; the potential for
pralatrexate to be an effective treatment option for patients with
relapsed or refractory PTCL; 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 the design of
or data collected from the PROPEL trial may not be adequate to
demonstrate the safety and efficacy of pralatrexate for the
treatment of patients with relapsed or refractory PTCL, or
otherwise be sufficient to support FDA approval; that the FDA may
disagree with the Company�s interpretations of data from
preclinical studies and clinical trials involving pralatrexate,
including the PROPEL trial, or otherwise determine such data are
not sufficient to support approval; and that the Company may lack
the financial resources and access to capital to support its future
operations, including the potential commercialization of
pralatrexate if approved for marketing. 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 March
31, 2009 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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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