Spectrum Pharmaceuticals Announces ROLONTIS™ (eflapegrastim) Met the Primary Endpoint in the Phase 3 ADVANCE Study
February 05 2018 - 7:00AM
Business Wire
- The ADVANCE study met the primary
efficacy endpoint of non-inferiority in Duration of Severe
Neutropenia between ROLONTIS and pegfilgrastim; adverse event
profile was similar between the two treatment arms.
- RECOVER, the second Phase 3 study,
is now fully enrolled. The Company plans to file a Biologics
License Application (BLA) in the fourth quarter of this
year.
- ROLONTIS is a novel, long-acting
granulocyte colony-stimulating factor (G-CSF) that utilizes a
proprietary technology.
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 today that the first Phase 3 study of ROLONTIS, ADVANCE,
has met its primary endpoint of non-inferiority in Duration of
Severe Neutropenia in comparison to pegfilgrastim. This study
evaluated the safety and efficacy of ROLONTIS in the management of
chemotherapy-induced neutropenia in 406 patients with early-stage
breast cancer. The incidence of adverse events in this study was
similar between the ROLONTIS and the pegfilgrastim arms. The
Company also announced that RECOVER, the second Phase 3 study, has
completed enrollment.
“The ADVANCE study affirms the efficacy and safety of ROLONTIS
that was observed in the Phase 2 study," 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. “If approved, this drug
would be a welcome addition to supportive care treatment options
for cancer patients receiving myelosuppressive cytotoxic
chemotherapy.”
“The positive top line data from our Phase 3 study is an
important milestone for Spectrum as we continue to move our Company
forward,” said Joe Turgeon, President and Chief Executive Officer
of Spectrum Pharmaceuticals. “Also, the completion of enrollment of
our second Phase 3, the RECOVER study, keeps us on track to file a
BLA in the fourth quarter of 2018. ROLONTIS has the potential to be
an important alternative for physicians and patients within this
multibillion dollar market.”
In accordance with the FDA Special Protocol Assessment, Phase 3
ADVANCE study was a multicenter, randomized, active-controlled
trial that enrolled 406 early-stage breast cancer patients, who
receive docetaxel and cyclophosphamide chemotherapy every 21 days.
Patients were randomized 1:1 to treatment with ROLONTIS or
pegfilgrastim. The primary study endpoint was 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.
In January 2012, Spectrum entered into a licensing
agreement with Hanmi Pharmaceuticals, gaining global rights for
ROLONTIS (except Korea, China, and Japan).
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.
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.® is a registered trademark of
Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER
CARE™, ROLONTIS™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2018 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice
President, Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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