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 detailed
results from ADVANCE, a Phase 3 trial of ROLONTIS, demonstrating that it
was non-inferior to pegfilgrastim in the reduction of duration of severe
neutropenia (DSN) in all four cycles of the study. ROLONTIS is a novel
long-acting granulocyte colony-stimulating factor (G-CSF) being studied
as a treatment for neutropenia in patients undergoing myelosuppressive
cytotoxic chemotherapy. The data released online today in an abstract as
part of the American Society of Clinical Oncology 2018 Annual Meeting,
also showed similar safety profiles between the treatment groups. The
abstract can be find online at https://meetinglibrary.asco.org/record/163382/abstract.
"These data expand our understanding of the clinical profile of
eflapegrastim and help establish it as a possible supportive care
treatment option for the multitude of patients undergoing chemotherapy,”
said Lee Schwartzberg, M.D., 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 study demonstrated strong non-inferiority of ROLONTIS to
pegfilgrastim, including a 95 percent confidence interval of the
difference in the DSN below zero in the first cycle of treatment,
helping further define the clinical profile of this novel treatment.”
In the ROLONTIS Phase 3 ADVANCE study (n=406), mean DSN±SD was
0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim,
demonstrating non-inferiority with 95 percent confidence interval (CI)
of ?DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. The non-inferiority of
ROLONTIS for DSN was maintained across all four treatment cycles. There
were no statistically significant differences in all secondary endpoints
including time to absolute neutrophil count (ANC) recovery, depth of ANC
nadir and incidence of febrile neutropenia in Cycle 1. The most common
adverse events, which were observed in less than 10 percent of patients,
were similar across both treatment groups and were mainly hematologic,
including neutropenia, lymphopenia, anemia and leukopenia.
"The ADVANCE study is a cornerstone in the ROLONTIS clinical program,
which includes two Phase 3 clinical studies involving approximately 800
patients,” said Joe Turgeon, President and CEO of Spectrum
Pharmaceuticals. "We are pleased that ROLONTIS has shown strong
non-inferiority data and comparable safety profile to the current
standard of care. ROLONTIS has the potential to be the first novel drug
in this multibillion dollar market in more than 15 years.”
Spectrum is currently conducting a second Phase 3 ROLONTIS trial,
RECOVER, a multi-center study being conducted in the USA, Europe and
Asia. The study is fully enrolled and expected to complete later this
year. The company plans to conduct a pre-BLA meeting with the FDA in
preparation for a planned BLA filing in the fourth quarter of 2018.
The ADVANCE study is a Phase 3 multicenter, randomized,
active-controlled trial that enrolled 406 early-stage breast cancer
patients, who received docetaxel and cyclophosphamide chemotherapy every
21 days for four cycles. Patients were randomized 1:1 to treatment with
ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210).
The primary study endpoint was the DSN (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
included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of
ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with
stage I to stage IIIA breast cancer were treated on Day 1 of each of the
four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide.
On Day 2 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) in a 1:1 ratio.
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
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.
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
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© 2018 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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