Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
Tuesday September 18, 7:01 am ET
- Millennium on track to file sNDA in first quarter 2008 -
CAMBRIDGE, Mass., Sept. 18 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the interim analysis results of the large, international Phase III VISTA(1) trial in patients with newly diagnosed multiple myeloma showed that the therapy of VELCADE, melphalan and prednisone (VMP) demonstrated a highly statistically significant improvement in all efficacy measures, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, compared to melphalan and prednisone (MP) alone. Based on the recommendation of an independent data monitoring committee (IDMC), which conducted the planned interim, the control arm of the trial was stopped early to allow patients still being treated with MP to have VELCADE added to their therapy.
"These results position VELCADE based therapy as a new standard of care for newly diagnosed multiple myeloma patients," said Paul Richardson, M.D., Associate Professor of Medicine, Harvard Medical School; Clinical Director, Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute Boston; and a lead investigator of the VISTA trial. "The combination of VELCADE with melphalan and prednisone surpassed all efficacy endpoints, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, and did so, much earlier than expected. We are excited at the possibility this new therapy could be available to our patients sooner."
In the first quarter of 2008, the Company plans to file a supplemental new drug application (sNDA) in the U.S. for use of VELCADE in patients with newly diagnosed multiple myeloma, based on the data from this trial, which was conducted under the special protocol assessment (SPA) process with the Food and Drug Administration (FDA). The Company also expects that these data will be presented at the December 2007 meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
"An approval in front-line multiple myeloma would double the number of patients eligible to receive the benefit of VELCADE," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are confident that VELCADE based therapies will become standard of care, since physicians typically use the most active agents in the front-line setting to improve long-term outcomes for patients."
The Phase III VISTA trial is being conducted by the Company and its co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (JJPRD). The trial randomized 682 patients with newly diagnosed multiple myeloma, ineligible for stem cell transplantation, to receive either VMP or MP, a recognized standard of care in this treatment setting. Patients were enrolled at 151 clinical trial sites in 22 countries. The primary endpoint of the trial is time-to-disease progression with secondary endpoints, including overall survival, progression-free survival, complete remission rate and safety. Side effects of the VELCADE based therapy were manageable and included those seen in previous VELCADE clinical trials. Professor Jesus San Miguel, M.D., Hematology Department Head, University Hospital of Salamanca, Spain, is the principal investigator.
Conference Call Announcement
In conjunction with this news release, Millennium will host a webcast today, Tuesday, September 18, 2007 at 8:00 A.M. ET. This webcast can be accessed by visiting the Investors section of the Company's website, millennium.com . Following the webcast, an archived version of the call will be available at the same address for 30 days. |
