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) studywill 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 Oncol26:2767-2778, 2008.
3 A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood89 (11): 3909-3918. 1997.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
KEYWORDS: United States North America Nevada
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