Spectrum Pharmaceuticals Announces Publication in the Journal of Clinical Oncology of Encouraging ZEVALIN Data in Patients with Mantel-Cell Lymphoma

  • First-line consolidation with ZEVALIN® following abbreviated RCHOP therapy improved overall response rate and complete response rate versus abbreviated RCHOP alone
  • Study met primary endpoint of 50% prolongation of time to treatment failure over that expected for standard RCHOP alone; estimated 73% 5-year overall survival with ZEVALIN
  • Addition of ZEVALIN for first-line consolidation may allow reduced intensity of initial chemotherapy for patients with mantel-cell lymphoma (MCL)

HENDERSON, Nev.--(BUSINESS WIRE)--Aug 2, 2012 - 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 Phase 2 clinical data for ZEVALIN® (ibritumomab tiuxetan) Injection in patients with mantel-cell lymphoma (MCL). The study, led by Dr. Mitchell R. Smith from Fox Chase Cancer Center in Philadelphia, published in the Journal of Clinical Oncology (JCO), the journal of the American Society of Clinical Oncology, showed that first-line consolidation with ZEVALIN treatment regimen, following initial therapy consisting of rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP) given for four courses, was well tolerated and improved overall response rate (ORR= PR + CR) from 68% after RCHOP to 82% after ZEVALIN . The complete response rate (CR/CRu) improved from 19% after RCHOP to 56% after consolidation with ZEVALIN. ZEVALIN consolidation also met the primary endpoint of 50% prolongation of time to treatment failure (TTF) over that expected for R-CHOP x6 alone. 1 While there is no apparent plateau in TTF, median overall survival (OS) has not been reached, with an estimated 5-year OS of 73%.

Centers participating in the clinical trial were member institutions of the Eastern Cooperative Oncology Group (ECOG): Fox Chase Cancer Center; Dana-Farber Cancer Center; Northwestern University; British Columbia Cancer Agency; Montefiore Cancer Center; University of Alabama, Birmingham; University of Wisconsin, Madison, and Stanford University.

“Two important ZEVALIN peer-reviewed articles have been published over the past week, first in BLOOD, demonstrating increased overall survival in the most common form of aggressive lymphoma, and now in the JCO, which results indicate that ZEVALIN can have a positive impact in MCL by enhancing response rates while allowing reduced intensiveness of initial therapy,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “We believe that the growing attention to ZEVALIN in both journal articles and at major medical meetings demonstrates both the critical need for new therapies in lymphoma and the excitement around this approach, including ZEVALIN utilization in first-line consolidation.”

According to the MCL study protocol, the trial enrolled individuals 18 years or older with Stage II-IV, histologically confirmed MCL (CD20+ and cyclin D1+) and no prior treatment. Fifty-two patients received initial therapy of four courses of RCHOP and, following no signs of disease progression, received first-line consolidation therapy with the ZEVALIN treatment regimen. The study design required 52 eligible patients to detect a 50% improvement in the median time to treatment failure (TTF) compared with that reported for six cycles of RCHOP. Study results showed the trial objective was met, in addition to demonstrating increases in ORR and CR/CRu.

ZEVALIN is currently under clinical investigation for treating MCL and has not been approved for use in this form of lymphoma.

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.

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1 Howard OM et al. Rituximab and CHOP induction therapy for newly diagnosed mantle-cell lymphoma: molecular complete responses are not predictive of progression-free survival. J Clin Oncol. 2002;20:1288-1294.

 

Contact: Spectrum Pharmaceuticals
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com

 

 

Posted: August 2012

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