High-Dose Zevalin(R) With Tandem Stem Cell Infusion Produces 87 Percent Overall Survival in Relapsed/Refractory or High Risk Non-Hodgkin's Lymphoma
SEATTLE, Oct. 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)(Nasdaq and MTA: CTIC) announced today that the Journal of Clinical Oncologyhas published the results of an innovative study that investigated high (bonemarrow ablative) dose Zevalin(R) ([90Y]-ibritumomab tiuxetan) followed byautologous stem cell infusions among 30 patients (median age 62 years) withrelapsed/refractory or high risk aggressive non-Hodgkin's lymphoma (NHL) noteligible for a chemotherapy-based transplant. High-dose myeloablativechemotherapy is an effective therapy for NHL but because it is associated withsignificant toxicities it is usually reserved for clinically fit and youngerpatients and therefore is not an option for many due to the average age of NHLpatients being approximately 60 years old. In this study, three cycles ofconventional chemotherapy were given followed by high dose chemotherapy with astem cell rescue and then followed by up to three times the standard dose ofZevalin with an additional stem cell rescue. This treatment regimen resultedin 83 percent of patients achieving a disease free state with a projectedoverall survival of 87 percent after a median follow up of 30 months.
High-dose Zevalin was well tolerated and no deaths were noted with thisregimen. The expected severe marrow suppression associated with myeloablativetreatment was seen but patients began to recover neutrophil and plateletcounts within 3 weeks. Only minor non-hematologic toxicities were observed.Infections, none greater than grade 3, were noted in 8 patients (27 %) buthospitalization for grade 3 febrile neutropenia was required in only 3patients. The authors concluded "the mild hematologic toxicity wasunprecedented for a myeloablative regimen." The authors go on to state that "Anotable and distinct difference in our study from virtually all other regimensof myeloablative polychemotherapy is the nearly complete absence of non-hematologic toxicity. Despite advanced age and presence of co-morbidities inmany patients, none experienced vital organ toxicities of any grade.Mucositis, a major cause of toxicity and even infectious mortality aftermyeloablative treatments, was absent, and all patients were able to maintainnormal oral intake of food and water. The excellent tolerability ofmyeloablative radioimmunotherapy was noteworthy in that 19 patients (63percent) had previously not met the eligibility criteria for chemotherapy-based autotransplantation regimens as a result of elderly age and/orcomorbidities."
"We continue to be impressed with the potential for radioimmunotherapy asan adjunct to, or as in this study, a partial replacement for high-dosechemotherapy in autotransplantation for relapsed-refractory or high risk CD-20positive B-cell non-Hodgkin's lymphomas," noted Jack Singer, M.D., ChiefMedical Officer at Cell Therapeutics. "This investigational regimen adds tothe growing body of clinical trial data indicating that Zevalin at higher thanFDA approved doses with a stem cell rescue, may provide an added clinicalbenefit when added to either traditional myeloablative doses of chemotherapy,or as in the present study, added to high-doses of standard chemotherapy."
Zevalin is currently approved in the United States for the treatment ofpatients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractoryfollicular NHL. The Zevalin therapeutic regimen has been given acceleratedapproval for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overallresponse rate, which is a surrogate for progression free survival.
About Zevalin(R)
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy calledradioimmunotherapy and is indicated as part of the Zevalin therapeutic regimenfor treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicularNHL. Zevalin is indicated, under accelerated approval, for the treatment ofrelapsed or refractory, rituximab-naïve, low-grade and follicular NHL based onstudies using a surrogate endpoint of overall response rate. It was approvedby the FDA in February of 2002 as the first radioimmunotherapeutic agent forthe treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex haveoccurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90Zevalin administration results in severe and prolonged cytopenias in mostpatients. Severe cutaneous and mucocutaneous reactions have been reported. Themost serious adverse reactions of the Zevalin therapeutic regimen wereprimarily hematologic, including neutropenia, thrombocytopenia and anemia.Infusion-related toxicities were associated with pre-administration ofrituximab. The risk of hematologic toxicity correlated with the degree of bonemarrow involvement prior to Zevalin therapy. Myelodysplasia or acutemyelogenous leukemia was observed in 2 percent of patients (8 to 34 monthsafter treatment). Zevalin should only be used by health care professionalsqualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com formore information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation ofwhite blood cells and normally spreads through the lymphatic system, a systemof vessels that drains fluid from the body. NHL can be broadly classified intotwo main forms -- aggressive NHL, a rapidly spreading acute form of thedisease, and indolent NHL, which progresses more slowly. According to theNational Cancer Institute's SEER database there were nearly 400,000 people inthe U.S. with NHL in 2004. The American Cancer Society estimates that 66,120people will be diagnosed with NHL in 2008 and more than 19,000 are expected todie.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed todeveloping an integrated portfolio of oncology products aimed at making cancermore treatable. For additional information, please visithttp://www.celltherapeutics.com.
This press release includes forward-looking statements that involve anumber of risks and uncertainties, the outcome of which could materiallyand/or adversely affect actual future results. Specifically, the risks anduncertainties that could affect the development of Zevalin include risksassociated with preclinical and clinical developments in the biopharmaceuticalindustry in general and with Zevalin in particular including, withoutlimitation, the potential for Zevalin to be proved safe and effective for thetreatment of additional indications as noted in this publication or any otherindication, determinations by regulatory, patent and administrativegovernmental authorities, competitive factors, technological developments, andcosts of developing, producing and selling Zevalin. You should also review therisk factors listed or described from time to time in the Company's filingswith the Securities and Exchange Commission including, without limitation, theCompany's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may berequired by law, CTI does not intend to update or alter its forward-lookingstatements whether as a result of new information, future events, orotherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: media@ctiseattle.com http://www.CellTherapeutics.com/press_room Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T: 206.272.4347 F: 206.272.4434 E: invest@ctiseattle.com http://www.CellTherapeutics.com/investorsSOURCE Cell Therapeutics, Inc.
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