Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced results of a
randomized study comparing ZEVALIN (ibritumomab tiuxetan) injection for
intravenous use plus high-dose BEAM chemotherapy vs. BEAM chemotherapy
alone, published online by the journal "CANCER”,
the Journal of the American Cancer Society (http://www.ncbi.nlm.nih.gov/pubmed/22252613##).
The paper, entitled "A Randomized Study
Comparing Yttrium-90 Ibritumomab Tiuxetan (ZEVALIN) and High-Dose BEAM
Chemotherapy Versus BEAM Alone as the Conditioning Regimen Before
Autologous Stem Cell Transplantation in Patients with Aggressive Lymphoma,”
presented results from a study conducted by six centers in Israel,
and
was authored by Avichai Shimoni, MD, Department of Bone
Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer.
Based on the exciting and promising results from this study, Spectrum’s
clinical development program for ZEVALIN will be expanded to include
support for a larger study using Z-BEAM for ASCT. The current clinical
program includes a Phase 3 study in Diffuse Large B-Cell Lymphoma, and a
trial to evaluate ZEVALIN in previously untreated follicular
non-Hodgkin’s lymphoma patients.
"This study highlights a major advance for DLBCL and other patients with
relapsed/refractory aggressive lymphomas since the PARMA study (1995)
established ASCT as standard of care in this setting,” said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. "Unlike indolent lymphomas, which are
characterized by extended remissions following treatment and overall
survival in excess of 16 years, the patients in this study had relapsed
aggressive lymphoma, with an abysmal prognosis even after standard ASCT
of less than 4-5 years survival in most series. As a result, leading
U.S. and international centers have come forward to expand on this trial
and confirm the benefits of Z-BEAM in ASCT. We believe confirmatory
results will lead to FDA approval and rapid adoption of ZEVALIN in this
setting.”
High-dose chemotherapy combined with autologous stem-cell
transplantation is the standard therapy for refractory/relapsed
aggressive lymphoma. However, there is no standard preparatory regimen
prior to ASCT. In the era of rituximab-containing frontline regimens, it
is becoming more challenging to salvage patients with ASCT in this
setting, and novel approaches are required. This was a randomized study
evaluating the safety and efficacy of standard-dose ZEVALIN 14 days
prior to ASCT, followed by high-dose BEAM chemotherapy (Z-BEAM) and ASCT
in refractory/relapsed aggressive lymphoma. The comparator group
received BEAM alone (Carmustine, Etoposide, Cytarabine, and Melphalan)
on Day -6 to -1 prior to ASCT.
Forty-three patients with CD20 positive, aggressive lymphoma were
randomized to a treatment arm (Z-BEAM, n=22) or control arm (BEAM alone,
n=21). Patient characteristics, engraftment kinetics, and toxicity
outcomes were similar between the 2 groups. Two-years after ASCT , 20
relapses had occurred, for a two-year progression-free survival (PFS) in
all patients of 48% (95% confidence interval, 32%-64%): 59% after Z-BEAM
and 37% after BEAM alone (p=0.20). Multivariate analysis identified
advanced age (hazard ratio [HR], 8.3; P= .001), high-risk disease
(relapse within 12 months of diagnosis and/or secondary International
Prognostic Index >2; HR, 2.8; p=.04), positive positron emission
tomography computed tomography pre transplant (HR, 2.4; p=0.07), and
BEAM alone (HR, 2.8; p=0.03) as poor prognostic factors. Intermediate
risk patients with 1 or 2 risk factors had better PFS with Z-BEAM
compared with BEAM: 69% and 29%, respectively (p=0.07). Two year overall
survival was 91% and 62% after Z-BEAM and BEAM, respectively (p=0.05).
Similar prognostic factors determined survival. The HR for BEAM alone in
the multivariate analysis was 8.1 (p=0.01).
The study authors concluded that standard-dose ibritumomab tiuxetan
combined with BEAM high-dose chemotherapy is safe and possibly more
effective than BEAM alone as a conditioning regimen for ASCT in the era
of rituximab-containing chemotherapy regimens.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus
in oncology and hematology, currently markets two oncology drugs, FUSILEV®
and ZEVALIN®, followed by two drugs, apaziquone and
belinostat, in late stage development with a goal of filing New Drug
Applications (NDAs) with the U.S. Food & Drug Administration in 2012.
The Company also has a diversified pipeline of novel drug candidates.
The Company’s strategy is comprised of acquiring, developing and
commercializing a broad and diverse pipeline of late-stage clinical and
commercial drug products. The Company has aggressive business
development and commercial operation teams that support a robust drug
development program encompassing clinical development, medical research,
regulatory affairs, and biostatistics and data management. The Company
also leverages the expertise of its worldwide partners to assist in the
execution of its strategy. For more information, please visit the
Company’s website at www.sppirx.com.
Important ZEVALIN® Safety
Information
Deaths have occurred within 24 hours of rituximab infusion, an essential
component of the ZEVALIN therapeutic regimen. These fatalities were
associated with hypoxia, pulmonary infiltrates, acute respiratory
distress syndrome, myocardial infarction, ventricular fibrillation, or
cardiogenic shock. Most (80%) fatalities occurred with the first
rituximab infusion. ZEVALIN administration can result in severe and
prolonged cytopenias in most patients. Severe cutaneous and
mucocutaneous reactions, some fatal, can occur with the ZEVALIN
therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for
ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Non-Hodgkin Lymphoma
According to the National Cancer Institute (www.cancer.gov),
there are expected to be 66,360 new cases of non-Hodgkin lymphoma
diagnosed and approximately 19,320 deaths in the United States in 2011.
Non-Hodgkin lymphoma is defined as any of a large group of cancers of
lymphocytes (white blood cells). Non-Hodgkin lymphomas can occur at any
age and are often marked by lymph nodes that are larger than normal,
fever, and weight loss. There are many different types of non-Hodgkin
lymphoma. These types can be divided into aggressive (fast-growing) and
indolent or low grade (slow-growing) types, and they can be formed from
either B-cells or T-cells. Prognosis and treatment depend on the stage
and type of disease.
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 our 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, leveraging the expertise of partners and employees,
around the world to assist us in the execution of our strategy, 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 our existing and new drug candidates, may not prove
safe or effective, the possibility that our existing and new
applications to the FDA may not receive approval, and other regulatory
agencies 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 lack of sustained revenue history, our limited marketing
experience, 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. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to update the
information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®,
and FUSILEV® are registered trademarks of
Spectrum Pharmaceuticals, Inc.
REDEFINING CANCER CARE™ and the
Spectrum Pharmaceutical logos are trademarks owned by Spectrum
Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights
Reserved.
