Bortezomib for injection shows positive results in newly diagnosed multiple myeloma patients

07-19-2006

Millennium Pharmaceuticals, Inc. (MLNM) announced results of a study that showed Velcade in combination with melphalan and prednisone (V-MP) appeared significantly superior to melphalan and prednisone (MP) alone in treating elderly patients with newly diagnosed multiple myeloma (MM) who were ineligible for stem cell transplantation.

The multicenter, phase 1/2 study evaluating the safety and efficacy of Velcade-based therapy demonstrated an overall response rate of 89%, including a high complete and near complete response rate of 43%. This compared favorably to historical control data for MP, a widely used therapy that rarely induces complete response. Complete response is considered an important prognostic factor for survival.(1-2) The study was prepublished online in the journal, Blood.

The open-label, dose-escalation study evaluated the safety and efficacy of V-MP in 60 newly diagnosed multiple myeloma patients between 65 and 85 years old, with almost half of all patients (47%) over 75 years old.

The published study is the basis for an ongoing company-sponsored, phase 3, international VISTA trial of Velcade in combination with V-MP versus MP alone in patients with newly diagnosed multiple myeloma that are not transplant candidates. The data are also consistent with results in this elderly population observed in a subgroup analysis of the phase 3 APEX trial, which investigated VELCADE treatment in patients with relapsed MM and included patients aged 65 years and older. Velcade was found to be equally effective in elderly and younger patients; the response rate did not differ substantially between the two groups. In addition, the overall incidence of adverse events was comparable across all age groups.

Two additional, phase 3, multicenter trials being conducted by international cooperative groups are evaluating Velcade based combinations in newly diagnosed patients who are eligible for transplantation. Collectively, these three front-line phase 3 studies are anticipated to enroll approximately 2,000 patients and interim results from one of these is expected by the end of the year.

Velcade is the market leader in relapsed multiple myeloma with over 44,000 patients treated worldwide, including clinical trials. It is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD).

This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2006, Pain & Central Nervous System Week via NewsRx.com.