Zevalin Consolidation in First-Line Therapy in Patients with Non-Hodgkin's Lymphoma Resulted in a Progression-Free Survival of Greater Than 67 Months
IRVINE, Calif.--(BUSINESS WIRE)--Dec 8, 2008 - Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that extended follow-up data for the ZEVALIN® ([90Y]-ibritumomab tiuxetan) First-line Indolent (FIT) study presented at the American Society of Hematology (ASH) Annual Meeting by Morschhauser, et al demonstrated the continued improvement in progression-free survival (PFS) following ZEVALIN consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieved a response to first-line therapy over chemotherapy alone. Additionally, ZEVALIN consolidation did not adversely affect the use of various effective second-line treatments including stem cell transplants in patients who relapsed.
“The FIT data speaks for itself. Patients achieving a complete remission (CR) after induction chemotherapy who received ZEVALIN consolidation achieved a median progression-free survival benefit of greater than 67 months, compared to 30.8 months in the control arm,” said Rajesh C. Shrotriya, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. “The addition of ZEVALIN as a consolidation therapy could represent a significant advancement and a changing treatment paradigm for patients with NHL.”
The multinational, controlled, randomized Phase 3 FIT study evaluated the benefit and safety of a single infusion of ZEVALIN in patients with follicular B-cell non-Hodgkin's lymphoma who had achieved a partial remission (PR) or a complete remission/complete remission unconfirmed (CR/CRu) after receiving standard first-line chemotherapy regimens. Patients were randomized to either ZEVALIN consolidation or no further therapy. The FIT trial results were first presented at the December 2007 ASH annual meeting. The results were subsequently published in the Journal of Clinical Oncology 2008 26(32):5156-64. At the 2008 ASH meeting, the investigators presented an additional 1-year follow-up (median follow-up of 42 months) of the FIT study that included 409 patients who achieved a CR/CRu or PR after induction therapy. Patients that achieved a CR after induction therapy achieved a median PFS of >67 months for the ZEVALIN arm compared to 30.8 in the control arm (HR 0.61[95% CI .41-.91]; p=0.015). Patients that achieved a PR after induction therapy achieved a median PFS of 29.6 months for the ZEVALIN arm compared to 6.7 months in the control arm (HR 0.36[95% CI .25-.51]; p<0.001).
Subsequent therapy with various modalities including chemotherapy, radiotherapy, immunotherapy, ZEVALIN and stem cell transplation (ASCT) was given to 63 patients in the ZEVALIN arm and 108 patients in the control arm, who achieved an overall response rate of 81% and 73%, respectively. The results demonstrate that administration of ZEVALIN as consolidation therapy does not preclude the use of effective second-line therapies.
No previously unreported toxicities were noted and there was no increase in the incidence of secondary malignancies to date in patients treated with ZEVALIN as compared to control patients.
ZEVALIN, a radioimmunotherapeutic (RIT), will be marketed in the United States by RIT Oncology, LLC for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. On December 1, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of ZEVALIN as first-line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. This does not represent any evaluation of the adequacy of the data submitted. 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.
If approved, ZEVALIN would be the first radioimmunotherapy available to patients as first-line consolidation therapy. It is estimated that there would be approximately 18,000 additional patients that currently receive first-line treatment which would potentially be eligible to use ZEVALIN under the proposed expanded label. Together with ZEVALIN's current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients that are rituximab-refractory or rituximab-naive, approval of ZEVALIN as first-line consolidation therapy will allow ZEVALIN to be used in several lines of NHL therapy.
About First-Line Consolidation Therapy
Consolidation therapy is a treatment given after initial induction therapy and is aimed at improving the quality of the patient response by further diminishing the number of cancer cells with the goal of extending the response duration.
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-naÃ¯ve, 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. Patients and healthcare professionals can visit www.ZEVALIN.com for more information.
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 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, as well as its contemplated transaction with Cell Therapeutics, Inc., the safety and effectiveness of ZEVALIN, ZEVALIN's potential, that if approved for first line therapy in NHL, an additional 18,000 patients per year would be eligible to receive ZEVALIN in that setting, that the addition of ZEVALIN in first-line consolidation therapy could represent a significant advancement and a changing treatment paradigm in treating patients with NHL, 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.
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ZEVALIN® is a registered trademark of Cell Therapeutics, Inc.
© 2008 Spectrum Pharmaceuticals, Inc.
Contact: Spectrum Pharmaceuticals, Inc.
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Posted: December 2008