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Integrated efficacy and safety results in 643 patients were consistent
with individual trial results (ADVANCE and RECOVER) -
The integrated data demonstrated that eflapegrastim provided an
absolute risk reduction of severe neutropenia of 6.5% compared to
pegfilgrastim in Cycle 1
HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with a primary focus in hematology and oncology, today announced
integrated analysis results from two Phase 3 clinical trials of
ROLONTIS. ROLONTIS is a long-acting granulocyte colony-stimulating
factor (G-CSF) being studied as a treatment for neutropenia in patients
undergoing myelosuppressive cytotoxic chemotherapy.
The analysis found that integrated efficacy and safety data from the two
identically designed Phase 3 trials – ADVANCE and RECOVER – were
consistent with results from the individual trials, demonstrating that
ROLONTIS was non-inferior to pegfilgrastim in the reduction of duration
of severe neutropenia (DSN) in all four cycles of treatment. The summary
was presented today during a poster session at the American Society of
Clinical Oncology 2019 Annual Meeting in Chicago.
“These integrated analyses confirm non-inferiority in efficacy and a
similar safety profile between eflapegrastim and pegfilgrastim across
all cycles of treatment, including a 95 percent confidence interval of
the difference in the DSN below zero in favor of ROLONTIS in the first
cycle of treatment,” said Lee Schwartzberg, M.D., FACP, lead
investigator, executive director, University of Tennessee West Cancer
Center. “Additionally, the integrated data demonstrated that
eflapegrastim provided an absolute risk reduction of severe neutropenia
of 6.5 percent compared to pegfilgrastim in Cycle 1. The incidence of
febrile neutropenia was low and similar between treatment arms. Adverse
events, irrespective of causality and grade, were also similar between
the treatment arms. These data strengthen our understanding of the
clinical profile of eflapegrastim and help establish it as a possible
new supportive care treatment option for patients undergoing
myelosuppressive chemotherapy.”
Integrated data derived from the two Phase 3 clinical trials,
demonstrated that in Cycle 1, the mean DSN±SD was 0.24±0.581 days for
ROLONTIS (n=314) and 0.36±0.789 days for pegfilgrastim (n=329),
demonstrating non-inferiority (p<0.0001). The non-inferiority of
ROLONTIS for DSN was maintained across all four treatment cycles (all
p<0.0001). The ROLONTIS arm had an absolute risk reduction of severe
neutropenia of 6.5% (95% CI: 0.2%, 13%) versus pegfilgrastim in Cycle 1.
Absolute risk reduction was defined as the difference in the percentage
of patients who experienced severe neutropenia (ROLONTIS 17.5%;
pegfilgrastim 24%). Febrile neutropenia (3.2% vs. 3%; p=NS) and
neutropenic complications (5.7% vs. 5.8%; p=NS) were similar between the
ROLONTIS and pegfilgrastim arms. Integrated safety data presented today
also showed that the adverse events in general, regardless of causality,
were not significantly different between the two treatment arms.
“Neutropenia remains a significant complication for people undergoing
myelosuppressive chemotherapy, potentially causing hospitalizations and
delays in much needed cancer treatment,” said Francois Lebel, M.D.,
F.R.C.P.C., chief medical officer, Spectrum Pharmaceuticals. “ROLONTIS
is the first rhG-CSF innovation in over 15 years. The integrated
analysis results, which included 643 patients combined, demonstrated
reproducible efficacy and an acceptable safety profile. We look forward
to potentially providing a new therapy to the patients and physicians
managing chemotherapy-induced neutropenia in the near future.”
Spectrum Pharmaceuticals is currently working on a revised Biologics
License Application (BLA) to submit to the FDA.
About ADVANCE
The ADVANCE trial is a Phase 3, multicenter, randomized,
active-controlled, open label trial that enrolled 406 early-stage breast
cancer patients, who received docetaxel and cyclophosphamide
chemotherapy every 21 days for four cycles. Patients were randomized in
a 1:1 ratio to receive ROLONTIS or pegfilgrastim (eflapegrastim n=196;
pegfilgrastim n=210). The primary trial 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 (3.6 mg G-CSF) or pegfilgrastim (6 mg) in a
1:1 ratio.
About RECOVER
The RECOVER trial is a Phase 3, multicenter, randomized,
active-controlled, open label trial 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 ROLONTIS
(n=118) or pegfilgrastim (n=119). The primary trial endpoint was the DSN
in Cycle 1 of chemotherapy (absolute neutrophil count [ANC]
<0.5×10^9/L), based on central laboratory assessment of ANC over a
21-day cycle. There were a total of four cycles evaluated in this trial.
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 (3.6 mg G-CSF)
or pegfilgrastim (6 mg) in a 1:1 ratio.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on
acquiring, developing, and commercializing novel and targeted drug
products, with a primary focus in hematology and oncology. Spectrum has
a strong track record of successfully executing across the
biopharmaceutical business model, from in-licensing and acquiring
differentiated drugs, clinically developing novel assets, successfully
gaining regulatory approvals, and commercializing in a competitive
healthcare marketplace. Spectrum has a late-stage pipeline with novel
assets that serve areas of unmet need. This pipeline has the potential
to transform the company in the near future.
Notice Regarding Forward-Looking Statements – Certain statements in
this press release may constitute “forward-looking statements” within
the meaning of the United States Private Securities Litigation Reform
Act of 1995, as amended to date. These forward-looking statements relate
to a variety of matters, including, without limitation, statements that
relate to Spectrum’s business and its future, including the Company’s
ability to advance development of its late-stage pipeline assets, the
ability of ROLONTIS to meet currently unaddressed medical needs and the
size of the potential market, the timing of the results of the clinical
trials run by Spectrum, the future potential of Spectrum’s existing drug
pipeline, the timing of the BLA filing with the FDA, the availability of
therapies related to ROLOTINIS and other statements that are not purely
statements of historical fact. These forward-looking statements are made
on the basis of the current beliefs, expectations, and assumptions of
the management of Spectrum and are subject to significant risks and
uncertainties that could cause actual results to differ materially from
what may be expressed or implied in these forward-looking statements.
Risks that could cause actual results to differ include, but are not
limited to, the uncertainties inherent in new product development,
including clinical trial results and additional analysis of existing
pre-clinical and clinical data, the possibility that Spectrum’s new and
existing drug candidates, including ROLONTIS, may not ultimately prove
to be safe or effective, the possibility that Spectrum’s new and
existing drug candidates, if approved, may not be more effective, safer,
or more cost efficient than competing drugs, 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. For a further discussion of risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks relating
to the business of Spectrum in general, see the risk disclosures in the
Annual Report on Form 10-K of Spectrum for the year ended December 31,
2018, and in subsequent reports on Forms 10-Q and 8-K and other filings
made with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS®
are registered trademarks 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.
© 2019 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Contacts
COMPANY CONTACT
Shiv Kapoor
Vice President, Strategic Planning
& Investor Relations
702-835-6300
InvestorRelations@sppirx.com