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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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