-- New Analysis of Pivotal PROPEL Trial Presented at 51st ASH Annual
Meeting --
NEW ORLEANS & WESTMINSTER, Colo.--(BUSINESS WIRE)--Dec. 7, 2009--
Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported a new analysis of
data from the Company’s pivotal PROPEL trial of FOLOTYN™ (pralatrexate
injection) in patients with relapsed or refractory peripheral T-cell
lymphoma (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. The analysis evaluated the
outcomes of patients who received a stem cell transplant (SCT) before or
after treatment with FOLOTYN. The results demonstrate that FOLOTYN may
be a potential treatment option for patients who have progressed after
receiving a prior autologous SCT and may also be a potential bridge to
an autologous or allogeneic SCT following response to FOLOTYN therapy.
These data were presented during a poster session at the 51st Annual
Meeting of the American Society of Hematology (ASH) in New Orleans, LA.
Among the 109 patients in the PROPEL trial evaluable for response, 18
(17%) had received autologous SCT previously, including 8 (7%) who
underwent autologous SCT as the most recent therapy prior to study
enrollment. Sixty-three percent (5/8) of patients who received
autologous SCT as their most recent therapy responded to treatment with
FOLOTYN, including two complete responses (CRs). In patients who
underwent autologous SCT at any time prior to treatment with FOLOTYN, an
overall response rate (ORR) of 33% (6/18) was observed, suggesting
single agent FOLOTYN can be an effective therapeutic option for patients
who have progressed after being exposed to an intense transplant
regimen. Importantly, the ORR to FOLOTYN for patients who had progressed
after prior SCT was comparable to that of the ORR of 29% (32/109)
observed in the overall PROPEL population.
Additionally, the data demonstrated that promising results were observed
in patients who responded to treatment with FOLOTYN and proceeded to
receive SCT as initial subsequent therapy. Of the 109 patients evaluable
for response, 6 proceeded to SCT after responding to FOLOTYN. Four of
the 6 patients had responded according to independent central review and
2 of the 6 patients had responded according to investigator assessment.
Thus, responses to FOLOTYN permitted patients to proceed to a potential
curative transplant option.
“Stem cell transplant may be offered with curative intent in patients
with PTCL,” said Barbara Pro, M.D., associate professor, T-cell Lymphoma
team leader at The University of Texas M D Anderson Cancer Center in
Houston. “Patients with PTCL are recognized as having a poor prognosis;
therefore, it is important to identify new tolerable agents with the
ability to induce a response for relapsed or refractory patients. This
analysis underscores the important role FOLOTYN may play for PTCL
patients who have failed to respond to prior therapies, progressed after
prior autologous stem cell transplant and as a bridge to stem cell
transplant for patients who respond to FOLOTYN therapy.”
About PROPEL
The open-label, single-arm, multicenter, international Phase 2 clinical
trial is the largest prospective study of its type ever conducted in
patients with relapsed or refractory PTCL. PROPEL enrolled 115 patients
with relapsed or refractory PTCL, 109 of whom were considered evaluable
for efficacy according to the trial protocol. Patients were considered
evaluable if they received at least one dose of FOLOTYN, their diagnosis
of PTCL was confirmed by independent pathology review, and they had
relapsed or refractory disease after at least one prior treatment.
Patients were treated with FOLOTYN at 30 mg/m2 once weekly by
IV push over 3-5 minutes for 6 weeks in 7-week cycles until disease
progression or unacceptable toxicity. In addition, patients received 1mg
of vitamin B12 intramuscularly every 8-10 weeks and 1.0-1.25
mg of folic acid orally on a daily basis.
The primary efficacy endpoint was overall response rate (complete
response, complete response unconfirmed and partial response) as
assessed by International Workshop Criteria (IWC). The key secondary
efficacy endpoint was duration of response. Response assessments were
scheduled at the end of cycle 1 and then every other cycle (every 14
weeks). Duration of response was measured from the first day of
documented response to disease progression or death. Response and
disease progression were evaluated by independent central review using
the IWC.
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 (1.0 -1.25 mg orally on
a daily basis) and receive vitamin B12 (1 mg intramuscularly
every 8-10 weeks) 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.
Adverse Reactions:
The most common adverse reactions observed in PROPEL were mucositis
(70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events (>3%), regardless of causality, were
pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea
and thrombocytopenia. Forty-four percent of patients experienced a
serious adverse event while on study or within 30 days after their last
dose of FOLOTYN. Twenty-three percent of patients discontinued treatment
due to adverse reactions.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethaxazole) may result in delayed renal
clearance.
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.
For additional important safety information, please see the full prescribing
information for FOLOTYN at www.allos.com.
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas (PTCL) are a diverse group of aggressive
T-cell and natural killer (NK)-cell non-Hodgkin’s lymphomas (NHL) that
account for approximately 10% to 15% of all newly diagnosed cases of NHL
in the United States.1-3 The American Cancer Society
estimates that approximately 66,000 new cases of NHL were diagnosed in
the U.S. in 2009. The Company estimates the current annual incidence of
PTCL in the U.S. to be approximately 5,600 patients. The outcome of
patients with PTCL is poor and the majority of patients ultimately have
refractory disease to a variety of agents, including multi-agent
chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and
prednisone) or CHOP-like regimens. The 5-year overall survival rate for
patients with PTCL is 25% to 40%, depending on sub-type.4-5
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 exploring the
potential of FOLOTYN in other indications. Allos retains exclusive
worldwide rights to FOLOTYN for all indications. Allos is headquartered
in Westminster, CO. For additional information, please 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 FOLOTYN to play an important role
for PTCL patients who have progressed after prior autologous stem cell
transplant or as a bridge to stem cell transplant for patients who
respond to FOLOTYN therapy; 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. Important factors that may cause actual results to differ
materially include, but are not limited to, the risks and uncertainties
associated with developing adequate sales, marketing and distribution
capabilities; the acceptance of FOLOTYN in the marketplace; the status
of reimbursement from third party payers; the Company’s dependence on
third party manufacturers; the Company’s compliance with applicable
regulatory requirements, including the healthcare fraud and abuse laws
and the Company’s post-marketing requirements; and the Company’s access
to capital to support its future operations, including product
development and commercialization plans 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
September 30, 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.
Note: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.
References:
-
The Non-Hodgkin's Lymphoma Classification Project. A clinical
evaluation of the International Lymphoma Study Group classification of
non-Hodgkin’s lymphoma. Blood. 1997;89(11):3909-3908.
-
Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update
[review]. Lancet Oncol. 2004;5(6):341-353.
-
O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell lymphomas
[review]. Curr Oncol Rep. 2008;134(5):202-207.
-
Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization of
peripheral T-cell lymphomas in a single North American institution by
the WHO classification. Ann Oncol 2004;15(10):1467-75.
-
Savage KJ. Peripheral T-cell Lymphomas. Blood Rev.
2007;21:201-216.
Source: Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com
