Millennium Pharmaceuticals reported overall response rates (ORR) as high as 75% from Phase II trials of Velcade for Injection combination therapy across four subtypes of non-Hodgkin's lymphoma (NHL): follicular, marginal zone, mantle cell lymphoma (MCL) and T-cell lymphoma. These data include positive results from the Phase II study of Velcade in combination with rituximab in follicular lymphoma, which served as the basis for an ongoing Phase III registration-enabling trial initiated earlier this year.
The multicenter Phase II study evaluated the safety and efficacy of Velcade in combination with rituximab in 81 patients with follicular or marginal zone lymphoma. ORR was 53% among patients treated with once-weekly Velcade and 57% among patients treated in the twice-weekly arm. Median time to progression (TTP) was nine months among patients treated with once- weekly and 9.9 months among patients treated with twice-weekly Velcade. Therapy was well tolerated.
Based on these results, a randomized Phase III trial of Velcade in combination with rituximab compared to rituximab alone was initiated earlier this year under a Special Protocol Assessment (SPA) with the FDA. Velcade received approval from the FDA on December 8, 2006 for treatment of patients with MCL who have received at least one prior therapy, marking the first indication for Velcade in lymphoma and the first therapy to receive FDA approval in this treatment setting.
The company also reported results from several clinical trials of Velcade for Injection combination therapies for treatment of relapsed multiple myeloma (MM). The results of these trials showed overall response rates (ORR) as high as 93% and complete and near complete response (CR/nCR) rates as high as 43%. Based on an interim analysis of a randomized Phase III trial announced by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), Velcade in combination with Doxil achieved a statistically significant improvement in time to disease progression (TTP), the primary endpoint of the study, compared to Velcade alone.