HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today publication of positive long-term clinical data for ZEVALIN® (ibritumomab tiuxetan) Injection in patients with advanced, relapsed follicular non-Hodgkin’s lymphoma (fNHL). The data, published in Blood, the journal of the American Society of Hematology, showed that addition of ZEVALIN following fludarabine, cyclophosphamide, rituximab (FCR) conditioning and nonmyeloablative allogeneic stem cell transplantation (NST) resulted in a significantly improved 6-year overall survival (OS) estimate of 80% (95% CI, 41%-95%) in chemotherapy refractory patients, thereby overcoming a strong negative prognostic factor that typically precludes these patients from receiving other treatment options. As reported in the literature, following three episodes of relapsed disease, patients with chemorefractory disease have a median survival of 1.5 years.1 The clinical trial data were presented most recently at the 53rd American Society of Hematology Annual Meeting in December 2011.
“It is very encouraging to see the publication of long-term clinical data showing that ZEVALIN's usage in this allogeneic transplantation regimen can contribute to improved overall survival in the abysmal prognostic group of patients with disease progression after multiple chemotherapy regimens and in some cases, even with the standard preparative regimen used in autologous stem cell transplantation,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “These data are very important to understanding the benefit of ZEVALIN in patients who receive allogeneic stem cells from donors and build on previously published and presented findings for autologous stem cell approach in these refractory patients. These data help solidify a role of ZEVALIN in stem cell transplantation.”
Dr. Shrotriya continued, “Holding our product to the highest standard of scientific evidence, we are pleased to report progress in our randomized stem cell transplantation trial, ‘SPINOZA’ (Study with Preparatory INduction Of ZEVALIN in Aggressive lymphoma), which has enrolled 39 patients to date. With recently expanded international participation, this trial is on target to enroll more than 150 patients who receive ASCT for relapsed Diffuse Large B-Cell Lymphoma, the most common form of aggressive lymphoma.”
In the clinical study reported this week in Blood, 26 fNHL patients undergoing NST (25 from peripheral blood and 1 from bone marrow) after FCR conditioning received ZEVALIN treatment regimen and were evaluated 1, 3, 6, and 12 months after NST; every 6 months up to 5 years; and yearly thereafter. With a median follow-up duration of 33 months (range, 17-94 months), the estimated OS and PFS rates at 3 years were 88% (95% CI, 68%-96%) and 85% (95% CI, 64%-94%), respectively. Results were similar to those in a separate group of patients (N=47) who received NST after FCR conditioning (salvage treatment) without ZEVALIN, in whom the 3-year OS and PFS estimates were 85% (95% CI, 71%-93%, P = 0.7) and 83% (95% CI, 69%-91%, P = 0.9), respectively. The addition of ZEVALIN was able to benefit highly refractory patients by providing outcomes similar to those who responded to the salvage regimen administered.
About Non-Hodgkin's Lymphoma
According to the National Cancer Institute (www.cancer.gov), there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and approximately 18,940 deaths in the United States in 2012. Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood 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. 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. 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 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 currently markets two oncology drugs ─ FUSILEV® (levoleucovorin) for Injection 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®, and FUSILEV® 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 Lister T.A. The management of follicular lymphoma. Annals of Oncology (1991)2(suppl 2): 131-135.