ZEVALIN Data as Preparatory Regimen Presented Prior to Autologous and Allogeneic Stem Cell Transplantation in the Treatment of Non-Hodgkin's Lymphoma
Data Presented In Oral Sessions At The 52nd Annual Meeting Of The American Society Of Hematology
ORLANDO, Fla.--(BUSINESS WIRE)--Dec 7, 2010 - Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced the presentation of ZEVALIN data as a preparatory or conditioning regimen prior to both allogeneic and autologous stem cell transplantation at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Prior to stem cell transplantation to a patient, the existing disease must be eradicated. Therefore, patients undergo conditioning regimens to eliminate, in the case of blood cancers, all or most of the tumor cells. This also destroys the patient's blood generating (hematopoietic) system. Following conditioning, stem cells either derived from the patient's own system (autologous) or from a matched donor (allogeneic) are introduced to the patient to renew the hematopoietic system.
“These data solidify the role of ZEVALIN in treatment regimens for lymphoma patients,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “These presentations confirm our belief that ZEVALIN will continue to show strong data in a range of protocols to prepare lymphoma patients for these life-saving procedures.”
Ajay K. Gopal, MD, Assistant Professor of Medical Oncology at the University of Washington School of Medicine and an Assistant Member of the Clinical Research Division of the Fred Hutchinson Cancer Research Center, presented data on the use of ZEVALIN, Fludarabine, and TBI based Non-Myeloablative Allogenic Transplant Conditioning for High-Risk B-Cell lymphomas (n=40). Non-myeloablative allogeneic transplantation (NMAT) can provide prolonged remissions in patients with advanced B-cell lymphoma via the graft versus lymphoma effect, though patients and donors need to be carefully selected. Dr. Gopal's data indicated that use of ZEVALIN in NMAT is safe and feasible, and can lead to early objective responses and prolonged disease control in a subset of patients.
Dr. Gopal's ASH presentation is entitled Y-90 Ibritumomab Tiuxetan, Fludarabine, and TBI Based Non-Myeloablative Allogeneic Transplant Conditioning for High-Risk B-Cell Lymphoma. ASH Abstract #33.
Avichai Shimoni, MD, from the Chaim Sheba Medical Center in Tel-Hashomer, Israel, presented data from a multicenter Phase 2 study of ZEVALIN as part of a transplantation preparatory regimen for patients with aggressive lymphomas. In randomized study (n=43), a rarity in the field of transplantation, a regimen including a standard dose of ZEVALIN (Z-BEAM) was compared with a commonly used regimen (BEAM) in the conditioning of patients prior to autologous stem cell transplantation (ASCT). High-dose chemotherapy and ASCT is a standard therapy for patients with refractory/recurrent aggressive lymphoma, who are still chemotherapy-sensitive after second-line therapy. Dr. Shimoni's data indicated that the addition of ZEVALIN (Z-BEAM) was feasible and added no toxicity incremental to what was observed on BEAM. In multi-variate risk-adjusted analysis (Cox Model), the benefit on progression-free survival (PFS) of adding ZEVALIN to BEAM was found to be significant (P=0.03). The benefit was most pronounced in patients with low-risk disease, who had a 2-year PFS of 89% in the Z-BEAM group compared to 44% in the BEAM group.
Dr. Shimoni's ASH presentation is entitled A Multi-Center Prospective Randomized Study Comparing Ibritumomab Tiuxetan (ZEVALIN) and High-Dose BEAM Chemotherapy (Z-BEAM) vs. BEAM Alone as the Conditioning Regimen Prior to Autologous Stem-Cell Transplantation in Patients with Aggressive Lymphoma: Possible Advantage for Z-BEAM in Low-Risk Patients. ASH Abstract #686.
Amrita Krishan, MD, Director of City of Hope National Medical Center's Multiple Myeloma Program, presented a retrospective analysis designed to compare outcomes for 92 patients with diffuse large B-cell lymphoma (DLBCL) who received stem cell transplants after conditioning with either total body irradiation (TBI) or ZEVALIN (Z-BEAM). The data demonstrated a trend toward improved progression-free survival (PFS) in the Z-BEAM cohort with a toxicity profile similar to high dose BEAM. Two-year PFS for the Z-BEAM group was 66% compared to 50% for the TBI group. Four years following stem cell transplant, patients treated with Z-BEAM demonstrated a 20% improvement in PFS compared to TBI patients.
Dr. Krishan's presentation is entitled Comparative Analysis of Autologous Hematopoietic Cell Transplantation with Radioimmunotherapy (RIT) Based Conditioning Versus Total Body Irradiation (TBI) for High-Risk Diffuse Large Cell Lymphoma (DLCL): Toxicity and Efficacy. ASH Abstract #32.
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's 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's lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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 results 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.
Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute's SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company's strategy is comprised of acquiring, developing and commercializing 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 drug 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 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 drug candidates may not receive approval from the FDA, 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 revenues, 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.
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Contact: Spectrum Pharmaceuticals, Inc.
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Posted: December 2010