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| |  ASH: Zevalin Combination Shows Encouraging Results In NHL NEW ORLEANS, LA -- December 7, 1999 -- IDEC Pharmaceuticals Corporation announced that preliminary results of four clinical trials of Zevalin (TM) (ibritumomab tiuxetan, IDEC-Y2B8), an investigational radioimmunotherapy, will be presented at the 41st Annual Meeting of the American Society of Hematology (ASH).
Zevalin is a monoclonal antibody that targets the CD20 antigen and is stably linked to the radioisotope 90Yttrium. This investigational agent is in late stages of development for the treatment of certain non-Hodgkin's lymphomas (NHL). "The interim Zevalin clinical response and safety data included in these presentations are encouraging," said Christine A. White, M.D., IDEC Pharmaceuticals' senior director of oncology and hematology and an author in all four presentations. "In addition, these preliminary data indicate that Zevalin can be dosed based on clinical factors including patient body weight and baseline platelet count without need for complex and time-consuming dosimetry. Final conclusions, of course, await completion of these studies. " Thomas E. Witzig, M.D. of the Mayo Clinic, Rochester, MN, delivered an oral presentation of Phase III interim results comparing Zevalin, plus Rituxan, to Rituxan alone in patients with relapsed or refractory, low grade, follicular or transformed CD20-positive, B-cell NHL. He reported that the prospectively defined 90-patient interim analysis of the multi-center, randomized controlled study showed an overall response rate (ORR) of 80 percent for the Zevalin group compared to ORR of 44 percent for the Rituxan group. A treatment course for Zevalin includes a Rituxan infusion (250 mg/m2) 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. Patients in the Rituxan arm received four infusions of Rituxan (at the indicated dose of 375 mg/m2) once a week over 22 days. Dr. Witzig also stated that 21 percent of the Zevalin group achieved a complete response to therapy and 59 percent achieved a partial response. Zevalin associated toxicity was primarily hematologic, transient and reversible. Six percent of patients in the Zevalin arm of the study experienced Grade 4 thrombocytopenia (platelet count below 10,000/mm3) and 25 percent experienced Grade 4 neutropenia (neutrophil count below 500/mm3). However, patients recovered in a median of 12 and 14 days, respectively. The overall safety profile for treatment with Rituxan in the study was similar to what has been outlined in the Rituxan package insert. Dr. Witzig also gave a poster presentation of interim results of a Phase II trial evaluating safety and efficacy of treating relapsed or refractory, low grade, follicular or transformed NHL patients with mild thrombocytopenia (platelet count between 100,000 and 149,000/mm3) with Zevalin at a reduced radiation dose (0.3 mCi/kg). The overall response rate in 22 evaluable patients was 68 percent with five patients (23 percent) achieving a complete response and 10 patients (45 percent) achieving a partial response. In the study, 25 percent of patients experienced Grade 4 neutropenia and 15 percent experienced Grade 4 thrombocytopenia. Again, the toxicity of Zevalin was primarily hematologic, transient and reversible with patients recovering in a median of 12 and 14 days, respectively.
Related Link: IDEC Pharmaceuticals Corporation.
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