ZEVALIN(R) Produced 83 Percent Complete Response Rate In Mucosa-Associated Lymphoid Tissue (MALT) Orbital Lymphoma Study

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Lymphology/Lymphedema
Article Date: 25 Jan 2009 - 1:00 PDT

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Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) announced results of a study published by Esmaeli, et al. online on January 15, 2009 in the Annals of Oncology demonstrating that rituximab followed by single agent ZEVALIN® (ibritumomab tiuxetan) in a front-line setting for patients with MALT lymphoma and low-grade follicular lymphoma that primarily involved the conjunctiva or orbit, produced a complete response rate of 83 percent.

Ocular adnexal lymphoma (OAL), defined as lymphoma affecting the orbit, eyelid and conjunctiva, is the most frequent primary malignant tumor of the orbit in adults, accounting for approximately 55 percent of all orbital tumors. MALT lymphoma is the most common histologic subtype of OAL, followed by low-grade follicular lymphoma. External-beam radiotherapy (EBRT) has been the most frequently used modality and is considered the gold standard for treating OAL that present with local disease. However, EBRT does not address systemic sites of involvement in OAL in patients with multifocal disease and therefore, systemic targeted radioimmunotherapy with ZEVALIN might offer an alternative to treating OAL.

In the study, 9 patients with MALT lymphoma of conjunctiva or orbit and 3 patients with low grade follicular lymphoma of the orbit received rituximab and Indium-111 ZEVALIN and then approximately 1 week later received a second infusion of rituximab followed by single dose of Yttrium-90 ZEVALIN.

Results demonstrated an initial response rate for patients of 100 percent with 83 percent achieving a complete response. There were no cases of extraorbital relapse, with a median follow-up time of 20 months. All 12 patients experienced Grade 1 or 2 transient pancytopenia during the first 3 months. Two patients had platelet transfusions, and one patient had blood transfusions due to myelosuppression. There were no episodes of Grade 3 or 4 toxicity.

The authors concluded that ZEVALIN may represent a reasonable alternative for front-line treatment of early-stage extranodal OAL, producing response rates similar to those with EBRT with one-tenth the absorbed radiation dose.

ZEVALIN is currently marketed in the United States by RIT (Radioimmunotherapeutics) Oncology, LLC, a joint venture between Spectrum Pharmaceuticals, Inc. and Cell Therapeutics, Inc. A sNDA for ZEVALIN as front-line consolidation therapy in patients with advanced follicular NHL has been submitted to the FDA for review. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the ZEVALIN sBLA.

About ZEVALIN®

ZEVALIN® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

For more information on ZEVALIN, patients and healthcare professionals can visit http://www.ZEVALIN.com.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms - aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.

About First-Line Consolidation Therapy

Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.

About RIT (Radioimmunotherapeutics) Oncology, LLC

Spectrum Pharmaceuticals and Cell Therapeutics are the sole members of the LLC, whose sole purpose is to commercialize ZEVALIN in the United States. The LLC is governed by a Board of Managers comprised of an equal number of members from both companies. Both parties are to equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com.

About Spectrum Pharmaceuticals

Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.

Forward-looking statements

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 include but are not limited to statements that relate to Spectrum's business and its future, the safety and effectiveness of ZEVALIN, that ZEVALIN may represent a reasonable alternative for front-line treatment of early-stage extranodal OAL, producing response rates similar to those with EBRT with one-tenth the absorbed radiation dose, 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 Spectrum's existing and new drug candidates, may not prove safe or effective, the possibility that its existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does 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.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

ZEVALIN® is a registered trademark of RIT Oncology, LLC, and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.

© 2009 Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals