Spectrum Pharmaceuticals Initiates Phase 3 Study of ZEVALIN® in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL); Most Common Form of Aggressive Non-Hodgkin's Lymphoma
• There is a substantial need for better treatments for DLBCL,
which has low survival rates at five years; there are an estimated
20,000 new cases of DLBCL in the U.S. each year
• The ZEST study follows multiple Phase 2 clinical trials
supporting advancement of ZEVALIN into a registrational-quality study in
aggressive lymphoma; results from the largest of the studies, presented
at the 2012 European Hematology Association annual meeting, showed an
84% 5-year overall survival (OS) rate and 75% 5-year progression-free
survival (PFS) in older patients with stage II-IV DLBCL who received
ZEVALIN following R-CHOP
• The ZEST (Zevalin Evaluation as Sequential Therapy) study
will compare the ZEVALIN therapeutic regimen to observation in
patients with newly diagnosed stage II, III, or IV DLBCL who are 60
years of age and older and who are in complete remission after
first-line R-CHOP or R-CHOP like chemotherapy for their disease
• Primary endpoint is overall survival; secondary endpoints
include 2-year OS rate and PFS
• Additional ZEVALIN clinical studies in aggressive lymphoma
include the SPINOZA (Study with Preparatory INduction Of Zevalin in
Aggressive lymphoma) trial, which to date has randomized 39 patients
receiving autologous stem cell transplantation (ASCT) for relapsed DLBCL
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with fully integrated commercial and drug development operations with a
primary focus in oncology and hematology, today announced initiation of
patient enrollment in the Company's randomized Phase 3 ZEST (Zevalin
Evaluation as Sequential Therapy) trial of ZEVALIN®
(ibritumomab tiuxetan) Injection for intravenous use for first-line
consolidation in patients with diffuse large B-cell lymphoma (DLBCL) who
achieved remission following R-CHOP chemotherapy (rituximab,
cyclophosphamide, doxorubicin, vincristine, and prednisone). The study
will assess overall survival (OS) and progression-free survival (PFS) in
patients 60 years and older. Patients will consist of newly diagnosed
Stage II — IV DLBCL patients with a complete response after the standard
six courses of R-CHOP. They will be randomized between observation and
ZEVALIN treatment.
"Initiation of the ZEST trial, together with our commitment to the
ongoing SPINOZA trial in patients with relapsed DLBCL who receive
autologous stem cell transplantation, represent a comprehensive clinical
program to determine the full potential of ZEVALIN in DLBCL, the most
common form of non-Hodgkin's lymphoma in which there is substantial
unmet need, especially in older patients," stated Rajesh C. Shrotriya,
M.D., Chairman, President and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc.
Dr. Shrotriya continued, "Spectrum has a number of near-term and
long-term clinical milestones for ZEVALIN, including presentations at
major medical meetings, both internationally and in the US, such as at
ASH and ASCO. In addition, a patient initiative launched earlier this
year and the acquisition of marketing rights in the EU should have a
strong impact on increasing awareness of the value of this important
product for the global lymphoma community."
Paul Hamlin, M.D., of the Lymphoma Service at Memorial Sloan-Kettering
Cancer Center and a lead investigator in the study, commented, "There is
a substantial need for better treatments for DLBCL, particularly in the
ever-increasing group of older patients who have fewer treatment options
than younger patients. A consolidative therapy that is administered in
just one week and improves survival would have a huge impact on lymphoma
patients' lives. The very encouraging evidence from earlier Phase 2
studies of ZEVALIN in aggressive lymphomas, both in terms of safety and
efficacy results, form the basis for the randomized study, and ZEVALIN
has the potential to expand our arsenal against this terrible disease."
Promising results of the largest of the Phase 2 studies were presented
at this year's annual meeting of the European Hematology Association
(EHA). The data demonstrated that ZEVALIN therapeutic regimen following
R-CHOP treatment resulted in a 5-year overall survival rate of 84% and
5-year progression-free survival of 75% in 44 older patients (age 62-86)
with stage II-IV DLBCL. Overall survival was improved
approximately 15% over that observed in similar risk patients treated
with R-CHOP alone,1 justifying confirmation of this finding
in a larger randomized trial.
"DLBCL consolidation therapy is a setting in which rituximab maintenance
has failed to show benefit in two randomized clinical trials, whereas
multiple Phase 2 studies have shown encouraging results for ZEVALIN
consolidation in this setting. We feel that success of ZEVALIN in the
ZEST study could lead to approval for its use in DLBCL consolidation
therapy," stated Dr. Shrotriya.
About Non-Hodgkin's Lymphoma
According to the SEER database, it estimated that more than 79,000
individuals will be diagnosed with and more than 20,000 will die of
lymphoma in 2012. Of these, approximately 70,000 will be diagnosed with
non-Hodgkin's lymphomas, resulting in approximately 18,940 deaths in the
United States in 2012.2 Diffuse large B-cell lymphoma (DLBCL)
is the most common form of non-Hodgkin's lymphoma, comprising
approximately 30% of cases.3
There are many different types of non-Hodgkin's 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. Non-Hodgkin's lymphomas can occur at any age and are often
marked by lymph nodes that are larger than normal, fever, and weight
loss. Prognosis and treatment depend on the stage and type of disease.
DLBCL occurs primarily in older people, with a median age at diagnosis
of 69.
About ZEVALIN® and the ZEVALIN Therapeutic
Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is
indicated for the treatment of patients with relapsed or refractory,
low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is
also indicated for the treatment of patients with previously untreated
follicular non-Hodgkin's Lymphoma who achieve a partial or complete
response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN
therapeutic regimen consists of two components: rituximab, and
Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on
the combined effect of a targeted biologic monoclonal antibody augmented
with the therapeutic effects of a beta-emitting radioisotope.
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 for ZEVALIN can be
found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in oncology and hematology. Spectrum markets three oncology drugs
─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN®
(pralatrexate injection), also marketed in the U.S.; and ZEVALIN®
(ibritumomab tiuxetan) Injection for intravenous use, for which the
Company has worldwide marketing rights. Spectrum's strong track record
in 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 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 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 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®,
FUSILEV®, and FOLOTYN®,
are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING
CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned
by Spectrum Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
1 Coiffier B, et al: Guidelines for the management of
pediatric and adult tumor lysis syndrome: An evidence-based review. J
Clin Oncol 26:2767-2778, 2008.
2 http://seer.cancer.gov/csr/
1975_2009_pops09/results_single/ sect_01_table.01.pdf
3 A clinical evaluation of the International Lymphoma Study
Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's
Lymphoma Classification Project. Blood 89 (11): 3909—3918.
1997.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice
President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com
Source: Spectrum Pharmaceuticals, Inc.
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