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 a total of 19
ZEVALIN related data presentations (5 oral, 14 posters) at the 53rd
Annual Meeting of the American Society of Hematology (ASH), being held
in San Diego, California, from December 10-13, 2011.
For more information about the ASH annual meeting and for a complete
list of abstracts, please refer to the conference Web site at www.hematology.org.
The following are the key ZEVALIN-related abstracts being presented at
the conference:
|
|
|
|
|
|
|
|
|
|
|
ORAL PRESENTATIONS
|
|
|
|
|
|
|
|
|
|
Date
|
|
Time
|
|
Abstract#
|
|
Type
|
|
Title
|
|
First Author
|
|
Location
|
|
Sunday, December 11, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:00 PM
|
|
99
|
|
Oral
|
|
Phase II Study with R-FND Followed by 90-Y Ibritumomab Tiuxetan
Radioimmunotherapy and Rituximab Maintenance for Untreated High-Risk
Follicular Lymphoma
|
|
Fowler
|
|
Room 6B
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:15 PM
|
|
100
|
|
Oral
|
|
Safety and Efficacy of 90Y Ibritumomab Tiuxetan (Zevalin®) for
Untreated Follicular Non-Hodgkin’s Lymphoma (FL) Patients, An
Italian Cooperative Study
|
|
Pica
|
|
Room 6B
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM
|
|
101
|
|
Oral
|
|
A Systematic Review and Meta-Analysis of Radioimmunotherapy
Consolidation for Untreated Patients with Follicular Lymphoma (FL)
|
|
Rose
|
|
Room 6B
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:45 PM
|
|
102
|
|
Oral
|
|
Fractionated 90y Ibritumomab Tiuxetan (ZevalinTM)
Radioimmunotherapy As An Initial Therapy of Follicular Lymphoma –
First Results From a Phase II Study in Patients Requiring
Treatment According to GELF/BNLI Criteria
|
|
Illidge
|
|
Room 6B
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monday, December 12, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3:00 PM
|
|
662
|
|
Oral
|
|
Nonmyeloablative Allogeneic Stem Cell Transplantation with/ or
without 90yttrium Ibritumomab Tiuxetan (90YIT) Is Curative for
Relapsed Follicular Lymphoma: Median 9 Year Follow-up Results
|
|
Khouri
|
|
Douglas Pavilion C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POSTER PRESENTATIONS
|
|
|
|
|
|
|
|
|
|
Date
|
|
Time
|
|
Abstract#
|
|
Type
|
|
Title
|
|
First Author
|
|
Location
|
|
Saturday, December 10, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM-7:30 PM
|
|
1572
|
|
Poster
|
|
Risk of Transformation of Follicular Lymphoma: A Prospective
Observational Single Institutional Experience
|
|
Burnette
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM-7:30 PM
|
|
1604
|
|
Poster
|
|
Fludarabine and Mitoxantrone Followed by Yttrium-90 Ibritumumab
Tiuxetan in Untreated Patients with Follicular Lymphoma. Long Term
Efficacy and Toxicity Results of the FLUMIZ Trial
|
|
Zinzani
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM-7:30 PM
|
|
1612
|
|
Poster
|
|
PET Evaluation Before Autografting Has a Strong Prognostic Impact in
High-Risk, Relapsed Follicular Lymphoma Patients
|
|
Ysebaert
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM-7:30 PM
|
|
1640
|
|
Poster
|
|
Prior Rituximab Exposure Does Not Appear to Affect Time to Treatment
Failure After Radioimmunotherapy
|
|
Burnette
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM-7:30 PM
|
|
1648
|
|
Poster
|
|
Phase I, Multicenter, Open Label, Dose Escalation of
90yttrium-Ibritumomab Tiuxetan Radioimmunotherapy Using a Modified
Regimen for Relapsed or Refractory Follicular or Transformed CD20+
B-Cell Lymphoma
|
|
Vaklavas
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5:30 PM-7:30 PM
|
|
2005
|
|
Poster
|
|
Mature Results of BEAM/High-Dose Rituximab Vs BEAM/Yttrium-90
Ibritumomab Tiuxetan (Zevalin®) and Autologous Stem Cell
Transplantation (ASCT) for Relapsed CD20+ Follicular and Diffuse
Large B-Cell Lymphoma: Survival Outcomes and Risk of Secondary
Malignancies
|
|
Zipp
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sunday, December 11, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
2701
|
|
Poster
|
|
First Evidence for High Incidence of Complete and Sustained
Molecular Remissions and Maintenance of Immune Responses in Patients
Receiving Consolidation with Y90 Ibritumomab Tiuxetan (90Y-RIT) Post
R-CHOP for Newly Diagnosed Advanced Stage High and Intermediate Risk
Follicular Lymphoma
|
|
Pennell
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
3027
|
|
Poster
|
|
Yttrium-90-Ibritumomab Tiuxetan (Zevalin) in Combination with a
Fludarabine-Based Reduced Conditioning Regimen (RIC) Followed by
Allogenic Stem Cell Transplantation for Advanced/Aggressive
Non-Hodgkin’s Lymphoma (NHL): A Prospective, Multicentre, Open Phase
II Study
|
|
Bouabdallah
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
3078
|
|
Poster
|
|
90yttrium Ibritumomab Tiuxetan-BEAM Followed by Autologous Stem Cell
Transplantation Significantly Improves Overall Survival After
Rituximab Containing Induction Therapy in Patients with High-Risk
Aggressive B Cell Non-Hodgkin’s Lymphoma
|
|
Wondergem
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
3095
|
|
Poster
|
|
A Phase I Trial of Zevalin Radioimmunotherapy with High-Dose
Melphalan (HDM) and Autologous Stem Cell Transplant (ASCT) for
Multiple Myeloma (MM)
|
|
Dispenzieri
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
3107
|
|
Poster
|
|
Radioimmunotherapy (RIT) with 90yttrium Zevalin Followed by BEAM
Conditioning Regimen (Z-BEAM) and Autologous Stem Cell
Transplantation (ASCT) for the Treatment of High Risk
Relapsed/Resistant Non Hodgkin’s Lymphoma (NHL)
|
|
Botto
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monday, December 12, 2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
3703
|
|
Poster
|
|
Yttrium-90-Ibritumomab Tiuxetan and BuCyE High-Dose Chemotherapy
Compared with BuCyE Alone As Conditioning Regimen in Patients with
B-Cell Non-Hodgkin Lymphoma: IPI Matched Case Control Study At a
Single Center
|
|
Jo
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
3713
|
|
Poster
|
|
Efficacy of 90yttrium-Ibritumomab Tiuxetan in Extranodal
Marginal-Zone Lymphoma
|
|
Vanazzi
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6:00 PM-8:00 PM
|
|
4157
|
|
Poster
|
|
A Pilot Phase II Study of C-MOPP-R, Ibritumomab Tiuxetan, and
Autologous Transplant for Untreated and Relapsed Follicular
Lymphoma: Response, Toxicity, and Feasibility
|
|
Fesler
|
|
Hall GH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
About ZEVALIN® and the
ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan), injection for intravenous use is
indicated for the treatment of patients with previously untreated
follicular non-Hodgkin Lymphoma (NHL), who achieve a partial or complete
response to first-line chemotherapy. ZEVALIN is also indicated for the
treatment of patients with relapsed or refractory, low-grade or
follicular B-cell non-Hodgkin lymphoma.
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. The ZEVALIN
therapeutic regimen is a form of cancer therapy called
radioimmunotherapy. 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 can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully
integrated commercial and drug development operations with a primary
focus in hematology and oncology. The Company’s strategy is to acquire,
develop and commercialize a broad and diverse pipeline of late-stage
clinical and commercial products. The Company markets two oncology
drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat,
in late stage development along with a diversified pipeline of novel
drug candidates. The Company has assembled an integrated in-house
scientific team, including clinical development, medical research,
regulatory affairs, biostatistics and data management, formulation
development, and has established a commercial infrastructure for the
marketing of its products. 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.
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.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights
Reserved.
