Allos Therapeutics, Inc. (NASDAQ: ALTH) today reported updated
results from the Company’s Phase 1 dose-finding study of FOLOTYN®
(pralatrexate injection) which supports the selection of 15 mg/m2
weekly for three weeks out of a four-week cycle as the optimal
starting dose and schedule for further evaluation in patients with
relapsed or refractory cutaneous T-cell lymphoma (CTCL). Data were
presented at the 52nd American Society of Hematology (ASH) Annual
Meeting in Orlando, Florida.
“We are continually seeking active and safe systemic therapies
to improve the outcomes for our patients with CTCL,” said Steven
Horwitz, M.D., assistant attending medical oncologist, Memorial
Sloan-Kettering Cancer Center, who is serving as the study chair.
“The overall activity in this trial, including the high response
rates, durability of response, and favorable safety profile is
quite promising. These results suggest that pralatrexate at this
dose and schedule may be another important option for treating
CTCL.”
CTCL is a group of T-cell non-Hodgkin lymphomas. In its early
stages, CTCL primarily affects the skin, causing patches, plaques,
and tumors, as well as redness and itching; however, as it
progresses, CTCL can spread to the blood, lymph nodes, and internal
organs. For some patients, their disease will progress despite
treatment with topical and skin directed therapies and will require
systemic treatments, including chemotherapies.1-2 Even when CTCL is
found in an early stage, it can be difficult to treat and usually
returns after initial treatment.2
This open-label, multi-center, dose-finding Phase 1 study
enrolled 54 patients with relapsed or refractory CTCL who received
at least one prior systemic therapy. The first phase of the study
employed a dose de-escalating strategy to determine an active,
well-tolerated dose and schedule of FOLOTYN in this population.
Once the optimal starting dose and schedule was determined to be 15
mg/m2 weekly for three weeks out of a four-week cycle, this cohort
was expanded to include a total of 29 patients. The Company had
previously announced interim results from this study.
At ASH 2010, data were presented on the 29 patients treated at
the optimal starting dose and schedule. Results showed:
- Overall response rate – the percentage
of patients whose cancer or tumor was reduced or disappeared after
treatment with FOLOTYN – was 45 percent (13 out of 29
patients).
- At the optimal dose, responses were
durable – with a Kaplan-Meier estimate for duration of response of
73 percent at six months.
- Median progression-free survival had
not been reached at the time of this analysis. At the optimal dose,
progression-free survival ranged from 1-429 days.
Of the total 54 patients enrolled in the trial (which includes
patients who received lower than the optimal dose), objective
responses were observed in 22 patients (41%), including three
complete responses (CR) and 19 partial responses. In total, 41 of
the 54 patients were treated at the optimal dose of FOLOTYN or
higher; of these 41 patients, responses were observed in 21
patients (51%). Responses to FOLOTYN were observed in patients
whose disease failed to respond to key prior systemic therapies,
including 46 percent of patients whose disease failed to respond to
oral bexarotene, 46 percent whose disease failed to respond to
methotrexate, 41 percent whose disease failed to respond to HDAC
inhibitors, and 36 percent whose disease failed to respond to
interferon. Patients in the study were heavily pretreated, having
received a median of 6.5 prior therapies (range 1-25) and 4.0 prior
systemic therapies (range 1-11).
All 41 patients treated at the optimal dose or higher were
evaluable for safety; of these patients, Grade 3-4 adverse events
observed were mucositis (17%), thrombocytopenia (3%), and fatigue
(3%); the most common Grade 1-2 adverse events observed were
fatigue (34%), mucositis (31%), nausea (31%), epistaxis/nose bleeds
(24%), edema (14%), and vomiting (14%). There was no neutropenia
reported in patients at the optimal dose or higher.
“Allos is pleased with the results observed in this early study
which demonstrated the activity of FOLOTYN in heavily pretreated
patients with relapsed or refractory cutaneous T-cell lymphoma,”
said Charles Morris, MB ChB, MRCP, chief medical officer at Allos
Therapeutics. “Based on these results, Allos intends to continue
investigating the role of FOLOTYN as an option for patients with
cutaneous T-cell lymphomas.”
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma, or CTCL, is comprised of indolent
non-Hodgkin T-cell lymphomas which have their primary
manifestations in the skin. The most common CTCL subtypes are
mycosis fungoides and Sézary syndrome. According to the Lymphoma
Research Foundation, CTCL accounts for approximately 2% to 3% of
the estimated 66,000 new cases of non-Hodgkin's lymphoma diagnosed
each year in the United States. The estimated annual prevalence of
CTCL in the United States is between 16,000 and 20,000 cases in the
U.S.1
About FOLOTYN
FOLOTYN, a folate analogue metabolic inhibitor, was discovered
by Sloan-Kettering Institute for Cancer Research, SRI International
and Southern Research Institute and developed by Allos
Therapeutics. In September 2009, the U.S. Food and Drug
Administration (FDA) granted accelerated approval for FOLOTYN for
use as a single agent for the treatment of patients with relapsed
or refractory 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. FOLOTYN has
been available to patients in the U.S. since October 2009.
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, and if skin reactions are
severe, FOLOTYN should be withheld or discontinued.
Adverse Reactions
The most common adverse reactions were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are 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/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.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 relapsed or
refractory CTCL, the potential future development of FOLOTYN for
the treatment of patients with relapsed or refractory CTCL; 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 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 relapsed or refractory CTCL; 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
September 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.
References
- Cutaneous Lymphoma Foundation. CTCL-MF
fast facts.
http://www.clfoundation.org/about_cutaneous_lymphoma/CL_fast_facts.pdf.
Accessed November 14, 2010.
- Romidepsin Reduces Disease Burden and
Skin Symptoms in Patients with Previously Treated Cutaneous T-Cell
Lymphoma. National Cancer Institute.
http://www.cancer.gov/clinicaltrials/results/summary/2010/romidepsin-CTCL1110.
Accessed November 18, 2010.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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