- 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.
HENDERSON, Nev.--(BUSINESS WIRE)--Feb. 5, 2018--
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20180205005261/en/
Source: Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice
President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com
