Spectrum Pharmaceuticals Announces Outstanding ZEVALIN Clinical Data In Aggressive Relapsed/Refratory Lymphoma; Presented at the 17th Congress of the European Hematology Association

  • Impressive and statistically significant (p=0.03) overall survival rate of 91% with ZEVALIN plus high dose chemotherapy (Z-BEAM) vs. 62% with BEAM chemotherapy alone was seen in aggressive relapsed/refractory lymphoma.
  • Early data published in January 2012 in “CANCER”, the Journal of the American Cancer Society, were updated.
  • ZEVALIN has the potential to become an integral part of the standard of care in pre-treatment of patients with aggressive lymphomas who require an autologous stem cell transplantation (ASCT).

HENDERSON, Nev.--(BUSINESS WIRE)--Jun 18, 2012 - 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 new clinical data presented in an oral presentation for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA). In one of only four abstracts accepted for oral presentation in the meeting's clinical transplantation session (Abstract # 1118), Dr. Avichai Shimoni (Chaim Sheba Medical Center, Tel Hashomer, Israel) presented an update with longer follow-up time from a multi-center, prospective randomized study, for which he reported that ZEVALIN administered in combination with BCNU, etoposide, cytarabine (Ara-C), melphalan (BEAM) therapy — Z-BEAM — resulted in a 91% two-year overall survival (OS) rate in patients with refractory/relapsed aggressive lymphoma, versus a 62% OS rate in patients administered BEAM alone (p=0.03). Based on these findings, which were updated from results published January 2012 in the journal "CANCER", the Journal of the American Cancer Society, Spectrum's development program for ZEVALIN has been expanded to include support for a larger, randomized international study using the Z-BEAM regimen as a preparative regimen for patients with lymphoma who receive autologous stem cell transplantation (ASCT). This international study, known as the “SPINOZA trial” (Study with Preparatory Induction Of ZEVALIN in Aggressive Lymphoma), recently started accrual.

“Patients with relapsed/refractory aggressive lymphomas have an abysmal prognosis and greatly reduced overall survival compared to those with indolent cancer. While stem cell transplantation has become the standard of care for appropriate patients in this setting, unfortunately there is no standard preparatory regimen prior to ASCT,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “We believe that these results, should they be confirmed in the broader clinical program currently underway, will be key in optimizing the preparative regimen by incorporating ZEVALIN and thus improving outcomes for these patients”.

In the Z-BEAM study, 43 patients with CD20-positive, aggressive lymphoma (34 with diffuse large B-cell lymphoma (DLBCL); 9 with transformed follicular lymphoma) were randomized to a treatment arm (Z-BEAM, N=22) or control arm (BEAM alone, N=21). Patient and disease characteristics were well matched between the groups. Median follow-up was 39 months, and at the time of analysis, all patients had reached the primary endpoint of 2-year overall survival. Results for overall survival were improved for patients receiving Z-BEAM compared to BEAM in 34 patients with DLBCL (2-year OS 94% Z-BEAM versus 56% BEAM, p=0.01). These and other findings from the study led the study researchers to conclude that “standard-dose ZEVALIN combined with BEAM high-dose chemotherapy is safe and possibly more effective than BEAM alone as conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.”

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, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late stage development and a diversified pipeline of novel drug candidates in earlier stages of development. 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, 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.

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.

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

 

Posted: June 2012

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