| November 13, 2002.
IDEC’s (NASDAQ:
IDPH) Zevalin (ibritumomab tiuxetan) generated updated response duration data out of its 143-patient, randomized, Rituxan-controlled, phase III clinical trial for the treatment of relapsed or refractory low-grade, follicular, or transformed B cell non-Hodgkin lymphoma (NHL). The data, presented at the annual meeting of the Society for Biological Therapy, support the use of Zevalin in this clinical scenario. Both Zevalin and Rituxan can induce long-term durable responses in patients with NHL.
The part of the investigation that provided data pivotal to Zevalin’s marketing application demonstrated that the Zevalin therapeutic regimen led to an overall response rate of 80% and a complete response rate of 34% percent, whereas the Rituxan control was associated with respective response rates of 56% and 20%. A trend toward longer time to disease progression for patients with follicular NHL was evident (15.0 versus 10.2 months).
Currently, among Zevalin complete responders, 32.1% remain in remission at 34 to 49 months of follow-up. Although Rituxan-control led to fewer complete responses with shorter median durations, 36% of Rituxan complete responders also have remained in remission for approximately 36 to 51 months of follow-up.
The Zevalin therapeutic regimen consists of Rituxan, then Indium-111 Zevalin (an “imaging dose” used with 2 or 3 whole body scans to image a patient’s tumor burden), followed seven to nine days later by a second infusion of Rituxan prior to Yttrium-90 Zevalin (therapeutic Zevalin). Zevalin is the first radioactive monoclonal antibody conjugate to receive FDA approval.
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