Spectrum Pharmaceuticals, Inc. Touts Lymphoma Drug Study Results
--ZEVALIN Has the Potential to Become Standard-of-Care in Pre-Treatment of ASCT Patients With Aggressive Lymphomas;
--ZEVALIN(R) is Currently Approved by the FDA and Marketed by Spectrum Pharmaceuticals in the United States for: Treatment of Patients with Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
--Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
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(R) and ZEVALIN(R), 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(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 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.(R), ZEVALIN(R), and FUSILEV(R) are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
(C) 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
SOURCE: Spectrum Pharmaceuticals, Inc.
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