Spectrum Pharmaceuticals Announces Results from the RECOVER Phase 3 Study of ROLONTIS® (eflapegrastim) at the 2018 SABCS Ann...
December 06 2018 - 7:00AM
Business Wire
- Primary endpoint of non-inferiority in
the Duration of Severe Neutropenia (DSN) between ROLONTIS and
pegfilgrastim was met
- No statistically significant
differences in adverse event rates between treatment groups
- RECOVER is the second ROLONTIS Phase 3
study to meet the primary efficacy endpoint of non-inferiority in
the DSN as compared to pegfilgrastim
- ROLONTIS is a novel, long-acting
granulocyte colony-stimulating factor (G-CSF) that utilizes a
proprietary platform technology to maximize the pharmacological
activity of G-CSF, resulting in increased biological activity and a
prolonged half-life
- ROLONTIS Biologics License Application
(BLA) filing is expected by the end of the year
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in hematology and oncology, today
announced that data from the Phase 3 RECOVER clinical study was
presented during the 2018 San Antonio Breast Cancer Symposium®
(SABCS). These data confirm the efficacy and safety of ROLONTIS®
(eflapegrastim) in reducing the Duration of Severe Neutropenia
(DSN) in breast cancer patients treated with chemotherapy. ROLONTIS
is a novel, long-acting granulocyte colony-stimulating factor
(G-CSF) being studied as a treatment for neutropenia in patients
undergoing treatment with myelosuppressive cytotoxic
chemotherapy.
“Despite available treatments, neutropenia remains a critical
issue for patients undergoing chemotherapy that puts them at risk
for developing life threatening infections,” said Lee
Schwartzberg, MD, FACP, lead investigator, professor of medicine
and division chief, hematology/oncology, University of Tennessee
Health Science Center, and executive director, UT/West Cancer
Center. “The robust data from both Phase 3 studies demonstrate
that ROLONTIS has the potential to be a valuable option in the
management of neutropenia for patients undergoing treatment with
chemotherapeutic agents.”
The data released yesterday in a poster presentation from the
ROLONTIS Phase 3 RECOVER study (n=237) showed that in Cycle 1, the
mean DSN±SD was 0.31±0.688 days for ROLONTIS and 0.39±0.949 days
for pegfilgrastim, demonstrating non-inferiority (p<0.0001). The
non-inferiority of ROLONTIS for DSN was maintained across all four
treatment cycles (all (p<0.0001)). Incidence of severe
neutropenia was 20 percent versus 24 percent in the eflapegrastim
and pegfilgrastim arms respectively, with a relative risk reduction
of 14 percent in favor of eflapegrastim. There were no
statistically significant differences on secondary endpoints such
as time to absolute neutrophil count (ANC) recovery, depth of ANC
nadir, and incidence of febrile neutropenia between treatment arms
across all cycles. None of the ≥Grade 3 study drug related adverse
events (AE) occurred in >2% of the patients and included
hematologic and bone pain related AEs in both arms.
The RECOVER trial is the second ROLONTIS Phase 3 study to meet
the primary efficacy endpoint of non-inferiority in mean DSN.
Results from ADVANCE, the first ROLONTIS Phase 3 study, were
announced at the 2018 American Society of Clinical Oncology (ASCO)
Annual Meeting and presented at the Multinational Association in
Supportive Care in Cancer Annual Meeting (MASCC) earlier this
year.
“The RECOVER study is the second Phase 3 study to confirm
non-inferiority data and comparable safety profile between ROLONTIS
and the current standard of care,” said Joe Turgeon, chief
executive officer of Spectrum Pharmaceuticals. “Data from both
studies, which enrolled 643 patients combined, will be used to
support the BLA filing which is expected to be submitted by the end
of the year. If approved, we look forward to having a unique
opportunity to launch and compete in this large market with the
first novel G-CSF in more than 15 years.”
About RECOVER
The RECOVER study is a Phase 3, randomized, open-label,
active-controlled, multicenter study that enrolled 237 breast
cancer patients who received docetaxel and cyclophosphamide
chemotherapy every 21 days. Patients were randomized in a 1:1 ratio
to receive either ROLONTIS (n=118) or pegfilgrastim (n=119). The
primary study endpoint was the DSN in Cycle 1 of chemotherapy
(absolute neutrophil count [ANC] <0.5×109/L), based on central
laboratory assessment of ANC over a 21 day cycle. There were a
total of four cycles evaluated in this study. Secondary endpoints
included, the DSN in Cycles 2, 3, and 4, time to ANC recovery,
depth of ANC nadir and incidence of febrile neutropenia at cycle
one. Patients with stage I to stage IIIA breast cancer were treated
on day one of each of the four cycles with adjuvant/neo-adjuvant
docetaxel and cyclophosphamide. On day two of each cycle, patients
received a single subcutaneous dose of either eflapegrastim
13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim
(6 mg).
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 seven 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.® and ROLONTIS® 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.
© 2018 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Shiv KapoorVice President, Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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