HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology Company with
fully integrated commercial and drug development operations with a
primary focus in Hematology and Oncology, announced two oral
presentations of data on FOLOTYN and research progress for the treatment
of Peripheral T-Cell Lymphoma (PTCL) at the 59th American Society of
Abstract #818: Pralatrexate in Combination with Cyclophosphamide,
Doxorubicin, Vincristine, and Prednisone (CHOP) in Previously Untreated
Patients with Peripheral T-Cell Lymphoma (PTCL): A Phase 1
In this study presented by Dr. Andrei Shustov from Division of
Hematology, University of Washington, a total of 31 patients have been
enrolled (19 in Part 1; 12 in Part 2). MTD was not reached and
pralatrexate dose of 30 mg/m2 in combination with CHOP was selected for
Part 2 of the study as predefined by the protocol. The majority of
patients were male, white, with the median age of 57.7 years (range,
18-78) at the time of enrollment. PTCL diagnoses included: anaplastic
large cell lymphoma, anaplastic lymphomakinase-negative (ALCL, ALK-,
n=5), peripheral T-cell lymphoma, not-otherwise specified (PTCL-NOS,
n=18), and angioimmunoblastic T-cell lymphoma (AITL, n=5). Fol-CHOP was
generally well tolerated with median RDI of 98%. Grade 3/4 adverse
events included anemia (23%), neutropenia (23%), fatigue (13%), and
vomiting (13%), as well as febrile neutropenia, nausea, and mucositis
each in 10% of the patients. SAEs were observed in 13 patients,
treatment related SAEs were anemia, febrile neutropenia, dehydration,
mucositis, and nausea. Six patients withdrew from study before the
completion of the follow-up, and dose reduction or dose delay occurred
in four patients. In the 29 patients evaluable for response, the
investigator assessed objective response (OR) and complete response (CR)
rates were 90% and 66%, respectively.
Abstract #342: The Role of Upfront Hematopoietic Stem Cell
Transplantation (HSCT) in Peripheral T-Cell Lymphoma (PTCL) Patients in
Complete Remission (CR) with a Special Focus on Nodal PTCL: Report from
the Comprehensive Oncology Measures for Peripheral T-Cell Lymphoma
Treatment (COMPLETE), a Prospective Multicenter Cohort Study
In this study, presented by Dr. Steven Park from Levine Cancer
Institute, a total of 499 PTCL patients were enrolled in COMPLETE over 4
years. Two hundred thirteen patients achieved a CR following frontline
therapy and had the required locked records for the analysis with a
median follow-up of 2.9 years (Range 1.9-4.0). One hundred forty nine
(70%) of these received induction therapy without HSCT consolidation and
64 (30%) underwent either autologous (n = 49) or allogeneic (n = 15)
HSCT. This is the first report from the largest prospective PTCL
database in the U.S. to date to examine the role of HSCT in PTCL
patients who are in first CR. Our data demonstrate potential survival
advantages of upfront HSCT in patients with nodal PTCL who achieve CR.
However, the results should be interpreted with caution given a
relatively short median follow up as well as the non-randomized study
design. The role of HSCT among various groups of PTCL patients in first
CR should further be evaluated in randomized controlled trials.
"We are honored that two oral presentations and multiple abstracts were
presented at the 59th ASH Meeting," said Rajesh C. Shrotriya,
MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
"FOLOTYN was the first drug approved for the treatment of relapsed or
refractory PTCL. PTCL is an aggressive disease with a poor prognosis and
we are excited that FOLOTYN has the potential to improve outcome for
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 currently markets six
hematology/oncology drugs, and has an advanced stage pipeline that has
the potential to transform the Company. Spectrum's strong track record
for 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.
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.
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.
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.
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
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 Spectrum's 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, the timing and results of FDA decisions, 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 Spectrum's 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 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. The Company does not plan to
update any such forward-looking statements and expressly disclaims any
duty to update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC.® and FOLOTYN® are
registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliate.
REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Planning & Investor Relations
Source: Spectrum Pharmaceuticals
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