Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that extended follow-up data for the Zevalin(R) ([90Y]-ibritumomab tiuxetan) First-line Indolent (FIT) study presented at the American Society of Hematology (ASH) 50th 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 study follow-on results are quite impressive when one considers that the median progression free survival for the Zevalin recipients that achieved a complete remission (CR) after induction therapy has not yet been reached with an estimated 67 months compared to 30 months with chemotherapy alone," said James A. Bianco, M.D., CEO of Cell Therapeutics. "A single dose of consolidation that could allow patients with a CR from requiring additional treatment for their NHL for over 3 years represents a significant advancement in the treatment of this disease."
The multinational, randomized phase III 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 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.
CTI has submitted a supplemental Biologics License Application (sBLA) to the FDA based on the FIT data obtained through an agreement with Bayer Schering Pharma AG, Germany. The FDA has accepted the application for review and granted a priority review status with a Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 for a decision on the application.
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.
About Zevalin(R)
Zevalin(R) (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-naive, 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(R)) 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 zevalin 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 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 celltherapeutics.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of Zevalin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin in particular including, without limitation, the potential for Zevalin FIT data to be acceptable to the FDA for this expanded indication or any other indication, the determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin, and the ability of CTI to continue to raise capital to fund its operations. There is also a risk that even if label expansion of Zevalin is approved, it may not result in a significant market increase for the drug due to the presence of other treatment options, failure to gain market acceptance and other factors. You should also review the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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