Zevalin Following Short-Course Chemotherapy with CHOP + Rituximab (CHOP-R) Doubles Complete Remission Rate in First-Line Treatment of Follicular Non- Hodgkin's Lymphoma
SEATTLE, November 10, 2008 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) announced today that Clinical Cancer Research has published in the November 1, 2008 issue the results of a study authored by Samual Jacobs et al. investigating the use of short-course CHOP-R followed by Zevalin ([90Y]-ibritumomab tiuxetan) and extended rituximab as first-line treatment in follicular non-Hodgkin's lymphoma patients. Addition of the Zevalin therapeutic regimen increased the complete responses from 40% for patients evaluated after 3 cycles of CHOP-R alone to 82% after the Zevalin regimen.
"This study adds to recently published First-line Indolent Trial (FIT) data indicating that the addition of Zevalin in patients who respond to first-line treatment of follicular non-Hodgkin's lymphoma patients may enhance the depth of response, even in patients whose induction therapy included rituximab-containing regimens," noted Jack Singer, M.D., Chief Medical Officer at Cell Therapeutics.
This trial enrolled 60 patients of which 55 patients completed all protocol therapy. Patients who had received no prior therapy with chemotherapy or monoclonal antibody received standard dose CHOP-R for 3 cycles followed by Zevalin then were treated with rituximab weekly for 4 doses. CHOP-R related toxicities included grade 3 to 4 neutropenia occurred in 23 (39%) patients and grade 3 to 4 thrombocytopenia occurred in 3 (5%) patients. The most frequent toxicity associated with Zevalin was myelosuppression. Grade 3 to 4 neutropenia occurred in 28 (51%) of patients with one incidence of febrile neutropenia requiring hospitalization. Grade 3 to 4 thrombocytopenia occurred in 44% of patients. However, all 55 patients who received Zevalin had normal white blood counts and platelet counts by after 12 weeks following administration.
Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. The Zevalin therapeutic regimen has been given accelerated approval for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.
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 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(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 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 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 www.celltherapeutics.com.
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 to be proved safe and effective for the treatment of additional indications as noted in this publication or any other indication, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin. 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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Posted: November 2008