The study is being conducted under Special Protocol Assessment
(SPA) agreement with the FDA.
This registrational, randomized, controlled Phase 3 study (ADVANCE)
will evaluate SPI-2012 as a treatment for chemotherapy-induced
neutropenia in approximately 580 patients with breast cancer.
The Company expects to have approximately 100 investigators in the
U.S. and Canada participate in this study; the goal is to complete
enrollment in 2017.
SPI-2012 is a novel, long-acting granulocyte colony-stimulating
factor (G-CSF) that utilizes a proprietary technology to maximize the
pharmacological activity of G-CSF, resulting in increased potency and
a prolonged half-life.
The worldwide commercial opportunity for the treatment of
chemotherapy-induced neutropenia is over $6 billion, and the approval
of SPI-2012 would provide the first novel, long-acting treatment
option to healthcare providers and their patients.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with fully integrated commercial and drug development operations and a
primary focus in Hematology and Oncology, announced today the Company
has initiated the planned registrational trial for SPI-2012
(eflapegrastim), its novel, long-acting G-CSF. This trial will evaluate
the safety and efficacy of SPI-2012 as a treatment for
chemotherapy-induced neutropenia in patients with breast cancer, and
will serve as the basis for the Biologics License Application (BLA)
"The initiation of the registration trial for SPI-2012 is a significant
milestone in the history of our company," said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
"Revenues from our current marketed drugs have helped us invest in this
exciting technology that opens the door for us to a blockbuster oncology
market. In parallel, Spectrum has built a strong commercial
infrastructure with specialized expertise in this indication that
positions us well to aggressively compete in this market."
"I am excited to be the lead investigator for this important study, and
about the potency and safety of SPI-2012 as demonstrated in Phase 2,"
said Lee S. Schwartzberg, M.D., FACP Professor of Medicine and Division
Chief, Hematology Oncology, The University of Tennessee Health Science
Center, and Executive Director, UT/West Cancer Center. "The LAPSCOVERY
technology confers long-acting properties and increased bone marrow
uptake through decreased renal and vascular clearance, as well as
Fc-mediated transport of G-CSF. We look forward to a successfully
conducted Phase 3 trial of SPI-2012. I believe this novel biologic drug,
if approved, would be a very valuable addition to our supportive care
armamentarium for cancer patients receiving myelosuppressive cytotoxic
"SPI-2012 is a third generation agent for the treatment of neutropenia
that has shown promising results in Phase 2 trials," said, Jeffrey L.
Vacirca, M.D., FACP CEO, Managing Partner & Chief of Clinical Research
at North Shore Hematology/Oncology Associates and Vice-President,
Community Oncology Alliance. "In the Phase 2 trial, the duration of
severe neutropenia was equivalent to pegfilgrastim at the medium dose
and superior at the high dose. No new or significant dose-related
toxicities have been observed in over 230 patients who have been treated
with SPI-2012, and the incidence of adverse events has been similar to
In accordance with the SPA, this registrational, Phase 3 or ADVANCE
Trial of SPI-2012 Versus
Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in
Breast CANCEr Patients Receiving
Docetaxel and Cyclophosphamide) is a multicenter, randomized, active
controlled trial that will enroll 580 newly diagnosed early-stage breast
cancer patients, who will receive adjuvant or neoadjuvant chemotherapy
every 21 days. Adjuvant chemotherapy is treatment given after primary
surgical therapy to kill any remaining cancer cells and increase the
chance of long-term disease-free survival; neoadjuvant chemotherapy is
the administration of cytotoxic agents before surgical resection in
early-stage breast cancer to shrink the tumor and potentially allow for
breast-conserving surgery. SPI-2012 will be administered subcutaneously
as a fixed dose equivalent to 3.6 mg of GCSF, which was selected based
on the robust pharmacological and pharmacodynamic data from Phase 2. The
primary study endpoint is the Duration of Severe Neutropenia (Absolute
Neutrophil Counts [ANC] < 0.5×109/L) in Cycle 1 of
chemotherapy, based on central laboratory assessment of ANC over the 21
day cycle. Secondary endpoints include the incidence of neutropenic
complications, incidence of Febrile Neutropenia, Relative Dose
Intensity, and safety.
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a Sponsor
and the U.S. Food and Drug Administration on the design, execution and
analysis for a clinical trial that may form the basis of a new Biologics
License Application or BLA. Final marketing approval depends upon the
efficacy results, safety profile and an evaluation of the risk/benefit
of treatment demonstrated in the Phase 3 clinical program.
About Breast Cancer
According to the American Cancer Society (ACS), breast cancer is the
second most common form of cancer in women after skin cancer, and the
second highest cause of female cancer deaths after lung cancer.
Unfortunately, it is estimated that about 1 in 8 (12%) of women in the
US will develop invasive breast cancer during their lifetime. In 2015 in
the United States (US), an estimated 231,840 new cases of invasive
breast cancer and 60,290 additional cases of in situ breast
cancer will be diagnosed, and approximately 40,290 US women are expected
to die from breast cancer. In addition, ~2,350 men are also expected to
be diagnosed with breast cancer in 2015 with an estimated 440 deaths.
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 five
hematology/oncology drugs, and expects an FDA decision on another
hematology drug in the first half of 2016. Additionally, Spectrum's
pipeline includes three drugs targeting blockbuster markets in advanced
stages of clinical development. 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
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.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com: http://www.businesswire.com/news/home/20160129005150/en/
Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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