- The FOLOTYN (antifolate) and an HDAC
inhibitor (romidepsin) combination was shown to achieve a 71%
overall response rate (ORR) among PTCL patients.
Spectrum Pharmaceuticals, Inc. (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 clinical study of FOLOTYN
plus Romidepsin in patients with relapsed or refractory Peripheral
T-Cell Lymphoma (PTCL) in an oral presentation session which was
presented at the 14th International Conference on Malignant
Lymphoma (ICML) meeting in Lugano, Switzerland.
“Promising doublets may create new treatment platforms and
change the paradigms of care for T-cell lymphoma,” concluded Dr.
Jennifer E. Amengual of the Columbia University Medical Center
Herbert Irving Comprehensive Cancer Center.
“We are excited about the encouraging data presented at the ICML
meeting,” said Rajesh C. Shrotriya, MD, Chairman and Chief
Executive Officer of Spectrum Pharmaceuticals. “These results show
that the combination of FOLOTYN, an antifolate, and an HDAC
inhibitor such as romidepsin could be highly effective in the
treatment of PTCL patients. FOLOTYN was the first drug approved for
the treatment of relapsed or refractory PTCL and it continues to be
used in pioneering research for this aggressive disease with poor
prognosis. We are encouraged that FOLOTYN has the potential to
further improve outcome for PTCL patients.”
Abstract #076: Results of the Phase I Study of FOLOTYN
(pralatrexate injection) plus Romidepsin reveals marked activity in
patients with relapsed or refractory (R/R) peripheral T-Cell
Lymphoma (PTCL)
29 patients were enrolled and evaluable for
toxicity. 23 patients were evaluable for response. The ORR in the
total, non-PTCL and PTCL populations was 57%, 33%, and 71%,
respectively. Of the PTCL 10/14 achieved a response with a CR= 4/14
(29%), PR=6/14 (43%), and 1 patient had stable disease. The mean
DOR in PTCL population (N=10) was 7.49 m (1.5 – 30.2+), PFS of 5.9
m (0.3 – 33.2+), and OS 10.8 m in this heavily pretreated patient
population.
Median age was 54 y (23-73) and 62% were
male. The median number of prior therapies was 3 (1-16).
Histologies included HL/other (N=4), B-cell (N=7), and T-cell
(N=18). There were 5 DLTs in cohort 3 (FOLOTYN 15 mg/m2 &
romidepsin 14 mg/m2) over both schedules consisting of 3 Grade 4
thrombocytopenias, 1 Grade 4 pancytopenia, and 1 Grade 4
neutropenia all attributed to romidepsin. There were 3 DLTs in
cohort 4A (FOLOTYN 20mg/m2 & romidepsin 12mg/m2given D1, 8
Q21D) consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis.
The D1, 15 Q28D schedule had no mucositis and resulted in no DLTs
at all dose levels. The Grade 3/4 toxicities reported in >5% of
patients were: anemia (29%), thrombocytopenia (28%), febrile
neutropenia (14%), oral mucositis (14%), hyponatremia (7%),
pneumonia (6%), neutropenia (6%), and sepsis (7%).
Results outlined in the presentation conclude
that the combination of FOLOTYN and romidepsin given on the D1, 15
Q28D schedule has an acceptable safety profile. These data support
the lineage specific activity of the FOLOTYN and romidepsin
combination with a 71% ORR in PTCL. A multicenter Phase II study of
FOLOTYN and romidepsin is now enrolling for PTCL.
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.
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
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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version on businesswire.com: http://www.businesswire.com/news/home/20170619005428/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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