Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology
announced the presentation of data from a case match control
analysis of the PROPEL Study in a poster presentation session at
the 58th American Society of Hematology (ASH).
Abstract #4149: Case Match Control Analysis of Propel Reveals
Survival Advantage for Patients with Relapsed/Refractory (R/R)
Peripheral T-Cell Lymphoma (PTCL) Treated with Pralatrexate
In this retrospective, observational study, 80 patients out of
109 treated on the PROPEL study were successfully matched 1:1 with
the control population. A highly significant difference in the
Overall Survival between the control population and the
pralatrexate group was observed. The overall survival observed in
the control population was 4.04 months (95% CI 2.60, 6.01) which
was consistent with historical controls, while the median OS in for
pralatrexate treated cohort was 14.78 months (95% CI 10.61-22.31).
The most common adverse reactions from the PROPEL study were
mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue
(36%). The most common serious adverse events were pyrexia,
mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia. See below for Important Safety Information.
“In this case match controlled study, the overall survival
observed in the pralatrexate group was over three-fold higher than
a case matched control group,” said 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. “The PROPEL
study, which was a Phase 2, open-label, single-arm, multi-center,
international trial, included patients that were heavily
pretreated, with a median of three prior systemic therapies
(ranging between 1 and 12). This is one of the first times a case
match control analysis has been used to understand the impact of a
drug on the outcome of a rare disease, like PTCL. Importantly, we
believe this may be a valuable paradigm that can be used in other
orphan diseases in cancer medicine.”
“We are honored to present this important data at the 58th ASH
Meeting,” said Rajesh C. Shrotriya, MD, Chairman and Chief
Executive Officer of Spectrum Pharmaceuticals. “We are encouraged
to see positive data continuing to emerge from the PROPEL study
that was the basis for FOLOTYN’s approval. FOLOTYN was the first
drug approved for the treatment of relapsed or refractory PTCL and
continues to have the leading market share in 2nd line therapy.
PTCL is an aggressive disease with a poor prognosis and we are
excited that FOLOTYN has the potential to improve outcome for PTCL
patients. We are also looking forward to emerging new data in
combination treatments that might prove to benefit PTCL patients in
earlier lines of treatment and with the possibility to include
FOLOTYN in future PTCL first line regimens.”
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
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.
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 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
trademark 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.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv Kapoor, 702-835-6300Vice President,
Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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