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|Analysis Suggests Increased Overall Survival with Use of Higher Cumulative Dose of VELCADE® (bortezomib) in Patients with Previously Untreated Multiple Myeloma|
New Orleans, LA, December 7, 2013 – Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited (TSE:4502), today announced results from a retrospective, subgroup analysis of the Phase 3 VISTA study that showed a higher cumulative dose of VELCADE® (bortezomib) suggests improved overall survival (OS) in previously untreated patients with multiple myeloma (MM) (hazard ratio [HR] 0.53; p<0.0001). Patients who received a cumulative dose of VELCADE of 39 mg/m2 or greater lived 20 months longer on average than those who received lower cumulative doses (median OS 66.3 months and 46.2 months, respectively). The subgroups were determined post-randomization and the analysis was retrospective.
The retrospective analysis was conducted using data from the VISTA study, which evaluated the safety and efficacy of a VELCADE-melphalan-prednisone (VMP) regimen of up to 54 weeks compared with melphalan-prednisone (MP) alone in patients with previously untreated MM. These data were presented today at the 55th American Society of Hematology (ASH) annual meeting held in New Orleans, LA on December 7-10, 2013.
"VISTA showed an overall survival benefit in multiple myeloma and it reinforces the importance of treating patients with a twelve-month course of VELCADE therapy,” said María-Victoria Mateos, MD, University Hospital of Salamanca, Salamanca, Spain. "This subgroup analysis, while retrospective, suggests that patients who received a dose of 39 mg/m2 or greater fared better than those who received a lesser dose."
VELCADE is approved by the U.S. Food & Drug Administration (FDA) for the treatment of MM and relapsed mantle cell lymphoma (MCL).
“Ten years after its introduction, VELCADE continues to make a difference in the lives of patients with multiple myeloma,” said Michael Vasconcelles, MD, Head, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “As we work to discover and bring new therapies to patients, we are also committed to helping patients get the most out of the treatments currently available.”
Higher Cumulative Bortezomib Dose Results in Better Overall Survival (OS) in Patients with Previously Untreated Multiple Myeloma Receiving Bortezomib-Melphalan-Prednisone (VMP) in the Phase 3 VISTA Study (Abstract #1968)
The poster presentation featured a retrospective, subgroup analysis of data from the VMP arm of the Phase 3 VISTA study that examined whether increased cumulative bortezomib dosing (total dosing received during the study) led to improved long-term outcomes. The VISTA study evaluated VMP vs. MP in transplant-ineligible patients with previously untreated MM in terms of response rates, time to progression (primary endpoint), and OS. The subgroups analyzed were determined post-randomization. The VMP subgroup analysis was presented by María-Victoria Mateos, MD, who reported the following:
As with all retrospective analyses, these data do not warrant the same merit as a prospective randomized trial.
Patients (n=340) treated with the VMP regimen in VISTA received up to nine six-week cycles (up to 54 weeks) of the combination therapy (cycles 1-4: VELCADE 1.3 mg/m2 IV, days 1, 4, 8, 11, 22, 25, 29, 32; cycles 5-9: VELCADE 1.3 mg/m2 IV, days 1, 8, 22, 29; all cycles: melphalan 9 mg/m2 and prednisone 60 mg/m2). The maximum planned dose of VELCADE was 67.6 mg/m2, including 41.6 mg/m2 during cycles 1-4 and 26 mg/m2 during cycles 5-9. The median cumulative VELCADE dose received was 39 mg/m2, which was selected as the cut-off point for defining patient groups by cumulative VELCADE dose for analyses of OS. A landmark analysis of OS from 180 days after the first dose to approximately align with cycles 1-4 of the study was conducted.
VELCADE: Important Safety Information
Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. VELCADE should not be administered intrathecally. Women should avoid becoming pregnant or breastfeeding while taking VELCADE. Patients with diabetes may require close monitoring and adjustment of their medication.
VELCADE can cause serious side effects, including:
Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, rash.
These are not all of the possible side effects with VELCADE. Please see the full Prescribing Information for VELCADE for a complete list available at VELCADE.com.
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