- Beleodaq is marketed in the U.S. by
Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a
biotechnology company with fully integrated commercial and drug
development operations with a primary focus in Hematology and
Oncology, announced today the publication of results from the
pivotal BELIEF (CLN-19) Study, which was selected as a Rapid
Communication in the Journal of Clinical Oncology (JCO), the
journal of the American Society of Clinical Oncology. The study,
led by Dr. Owen O’Connor from the Center for Lymphoid Malignancies,
Department of Medicine, Columbia University Medical Center, New
York, NY, showed that monotherapy with Beleodaq produced complete
and durable responses with manageable toxicity in patients with R/R
PTCL across the major subtypes, irrespective of the number or type
of prior therapies.
Beleodaq, previously known as belinostat, is a histone
deacetylase (HDAC) inhibitor indicated for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL). This indication is approved under accelerated approval
based on tumor Response Rate and Duration of Response. An
improvement in survival or disease-related symptoms has not been
established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trial.
Peripheral T-cell lymphomas are a diverse group of non-Hodgkin
lymphomas with a poor prognosis and no accepted standard of care
for relapsed or refractory patients. Unfortunately, current
treatment options for most of these patients induce responses in
only a minority of cases (<30%), and thus long-term survival is
relatively poor. The BELIEF study evaluated the efficacy and
tolerability of Beleodaq as a single agent in R/R PTCL. This study
was an open-label, single-arm, non-randomized, international trial
conducted at 62 centers that enrolled 129 patients with R/R PTCL,
who had progressed following ≥1 prior therapy with a median
number of prior therapies of two (1-8). These patients received
Beleodaq (1,000 mg/m2) as daily 30-minute infusions on
Days 1-5 every 21 days until disease progression or
unacceptable toxicity.
The primary endpoint of the BELIEF study was ORR as
assessed centrally by an Independent Review Committee using the
International Working Group (IWG) criteria. The ORR in the 120
evaluable patients was 25.8% (31 patients) (95% CI 18.3 - 34.6),
including 13 Complete Responses (10.8%) (95% CI 5.9 - 17.8) and 18
Partial Responses (15%) (95% CI 9.1 - 22.7). Secondary endpoints
included a median DoR of 13.6 months by IWG criteria and 8.4
months to disease progression or death, with the longest ongoing
patient at ≥36 months. The most common Grade 3/4 adverse events
were anemia (10.8%), thrombocytopenia (7%), dyspnea (6.2%), and
neutropenia. No clinically relevant ECG changes were identified,
and cardiovascular monitoring of ECGs is not required at baseline
or during treatment. In this pivotal study, monotherapy with
Beleodaq produced complete and durable responses with manageable
toxicity in patients with R/R PTCL across the major disease
subtypes, irrespective of the number or type of prior therapies and
with a low incidence of Grade 3/4 thrombocytopenia.
“We are pleased to have the results of the pivotal Beleodaq
study selected for publication as a Rapid Communication in such a
prominent journal,” said Rajesh C. Shrotriya, MD, Chairman and
Chief Executive Officer of Spectrum Pharmaceuticals. “This is a
highly distinguished category that JCO reserves for papers judged
to have special impact to their broad clinical readership. Spectrum
has a unique PTCL franchise, marketing two FDA approved drugs for
this indication, Folotyn® (pralatrexate injection) and
Beleodaq. We are very proud to be able to offer patients and
clinicians more treatment options with two approved treatments for
R/R PTCL.”
“This is a very exciting time in the treatment of patients with
PTCL,” said Dr. Owen A. O'Connor, MD, PhD, Director of the Center
for Lymphoid Malignancies, Professor of Medicine and Experimental
Therapeutics at Columbia Medical Center, New York Presbyterian
Medical Center, one of the lead investigators in the BELIEF
study. “At long last we finally have tools in the therapeutic
armamentarium to help our patients. Belinostat represents the
latest drug approved for patients with R/R PTCL that has relatively
few side effects and produces long durations of benefit, even in
patients who have received multiple conventional treatments in the
past. Now that we have several new options to treat the disease
when it comes back, we need to use these drugs to make better
up-front treatment platforms; Belinostat will be an important part
of that future.”
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in hematology and oncology. Spectrum
markets five hematology/oncology drugs, and expects an FDA decision
on another hematology drug later this year. Additionally,
Spectrum's pipeline includes three drugs targeting blockbuster
markets in advanced stages of clinical development. Spectrum's
strong track record in in-licensing and acquiring differentiated
drugs, and expertise in clinical development have generated a
robust, diversified, and growing pipeline of product candidates in
advanced-stage Phase 2 and Phase 3 studies. More information on
Spectrum is available at www.sppirx.com.
About BELEODAQ®
Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs
catalyze the removal of acetyl groups from the lysine residues of
histones and some non-histone proteins. In vitro, Beleodaq caused
the accumulation of acetylated histones and other proteins,
inducing cell cycle arrest and/or apoptosis of some transformed
cells. Beleodaq shows preferential cytotoxicity towards tumor cells
compared to normal cells. Beleodaq inhibited the enzymatic activity
of histone deacetylases at nanomolar concentrations (<250
nM).
Please see Beleodaq Full Prescribing Information at
www.beleodaq.com.
Indications and Usage
Beleodaq is a histone deacetylase inhibitor indicated for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma (PTCL). This indication is approved under accelerated
approval based on tumor response rate and duration of response. An
improvement in survival or disease-related symptoms has not been
established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trial.
Important Beleodaq Safety Information
Warnings and Precautions
- Beleodaq can cause thrombocytopenia,
leukopenia (neutropenia and lymphopenia), and/or anemia; monitor
blood counts weekly during treatment, and modify dosage as
necessary.
- Serious and sometimes fatal infections,
including pneumonia and sepsis, have occurred with Beleodaq. Do not
administer Beleodaq to patients with an active infection. Patients
with a history of extensive or intensive chemotherapy may be at
higher risk of life threatening infections.
- Beleodaq can cause fatal hepatotoxicity
and liver function test abnormalities. Monitor liver function tests
before treatment and before the start of each cycle. Interrupt or
adjust dosage until recovery, or permanently discontinue Beleodaq
based on the severity of the hepatic toxicity.
- Tumor lysis syndrome has occurred in
Beleodaq-treated patients in the clinical trial of patients with
relapsed or refractory PTCL. Monitor patients with advanced stage
disease and/or high tumor burden and take appropriate
precautions.
- Nausea, vomiting and diarrhea occur
with Beleodaq and may require the use of antiemetic and
antidiarrheal medications.
- Beleodaq can cause fetal harm when
administered to a pregnant woman. Women of childbearing potential
should be advised to avoid pregnancy while receiving Beleodaq. If
this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
potential hazard to the fetus.
Adverse Reactions
- The most common adverse reactions
observed in the trial in patients with relapsed or refractory PTCL
treated with Beleodaq were nausea (42%), fatigue (37%), pyrexia
(35%), anemia (32%), and vomiting (29%).
- Sixty-one patients (47.3%) experienced
serious adverse reactions while taking Beleodaq or within 30 days
after their last dose of Beleodaq.
Drug Interactions
- Beleodaq is primarily metabolized by
UGT1A1. Avoid concomitant administration of Beleodaq with strong
inhibitors of UGT1A1.
Use in Specific Populations
- It is not known whether Beleodaq is
excreted in human milk. Because of the potential for serious
adverse reactions in nursing infants from Beleodaq, a decision
should be made whether to discontinue nursing or discontinue drug,
taking into account the importance of the drug to the mother.
About FOLOTYN®
FOLOTYN, (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by Memorial Sloan-Kettering Cancer
Center, 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. An updated analysis of data from PROPEL, the
pivotal study of FOLOTYN in patients with relapsed or refractory
PTCL, was published in the March 20, 2011 issue of the Journal of
Clinical Oncology. FOLOTYN has patent protection through July 2022,
based on a five-year patent term extension through the Hatch-Waxman
Act.
Important FOLOTYN® 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 greater-than or equal to 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.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued. Tumor
lysis syndrome may occur. Monitor patients and treat if needed.
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 greater-than
or equal to Grade 3, omit or modify dose.
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.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including
certain company milestones, Spectrum's ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, leveraging the
expertise of partners and employees around the world to assist us
in the execution of our strategy, and any statements that relate to
the intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that our existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new applications
to the FDA and other regulatory agencies may not receive approval
in a timely manner or at all, the possibility that our existing and
new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that
our efforts to acquire or in-license and develop additional drug
candidates may fail, our lack of sustained revenue history, our
limited marketing experience, our dependence on third parties for
clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange
Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™,
EVOMELA™ and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are
the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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