Final results of the two ZEVALIN pivotal trials in radioimmunotherapy for B cell Non-Hodgkins Lymphoma announced by IDEC Pharmaceuticals at 42nd annual Society of Hematology meeting -- Three Additional Studies of ZEVALIN Also Presented
SAN FRANCISCO, CALIFORNIA -- Dec. 5, 2000 -- IDEC Pharmaceuticals Corporation (Nasdaq:IDPH) announced the final results of two pivotal trials of ZEVALIN (Ibritumomab Tiuxetan), an investigational radioimmunotherapy, during oral presentations at the 42nd Annual Meeting of the American Society of Hematology (ASH).
Thomas E. Witzig, M.D. of the Mayo Clinic, Rochester, MN, today delivered an oral presentation of a Phase III randomized, controlled study of 143 patients with relapsed or refractory low grade, follicular, or CD20-positive transformed B-cell Non-Hodgkins Lymphoma (NHL). He noted that the ZEVALIN combined with Rituxan arm of the study showed an overall response rate (ORR) of 80 percent, compared to the Rituxan (Rituxumab) alone control arm, which showed an overall response rate of 56 percent. A treatment course for ZEVALIN includes a Rituxan infusion (250 mg/m.2) on day one, followed by infusions of Rituxan (250 mg/m2) and ZEVALIN (at a standard radiation dose of 0.4 mCi/kg of patient body weight) on day eight. A treatment course of the Rituxan control consisted of four weekly doses of 375 mg/m2 of Rituxan.
Dr. Witzig said that 30 percent of the ZEVALIN patients achieved complete responses to therapy. Sixteen percent of Rituxan patients achieved complete responses. To date duration of response estimates between ZEVALIN plus Rituxan and Rituxan alone are not statistically different but further analysis will be conducted as data matures.
ZEVALIN associated toxicity was primarily hematologic, transient and reversible. Thirty-two percent of patients in the ZEVALIN arm of the study experienced Grade 4 neutropenia (neutrophil count below 500/mm3) and five percent experienced Grade 4 thrombocytope
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