VELCADE(R) (bortezomib) for Injection Based Induction Therapy Delivered High Post-Transplant Complete Remission Rate, a Critical Marker for Increased Overall Survival
Monday July 2, 8:01 am ET
- New Data from Phase III Intergroupe Francophone du Myelome (IFM) Trial Presented During IMW -
CAMBRIDGE, Mass., July 2 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today reported that new data were presented on the comparative Phase III clinical trial evaluating a VELCADE based therapy in newly diagnosed multiple myeloma (MM) patients. As induction therapy prior to stem cell transplantation (SCT), the VELCADE based therapy produced a high complete remission / complete response(1) (CR) rate of 20 percent, which led to a post SCT CR rate of 43 percent. These results were substantially stronger than those of a commonly used induction chemotherapy regimen vincristine, adriamycin and dexamethasone (VAD), which served as the comparative therapy in the trial. The data showed that the VELCADE based therapy, compared to VAD, nearly doubled the CR rate as induction therapy and provided a greater than 50 percent improvement in CR rate following SCT. Achievement of CR is the goal of SCT therapy because achievement of CR increases both progression-free and overall survival. The data were presented in conjunction with the prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece.MLNMLOGO )
"Historically, stem cell transplantations generated similar response rates regardless of the induction therapy due to the limited efficacy of these therapies. With VELCADE, we now have a powerful agent that has consistently delivered high complete remission rates during induction and has allowed physicians to mobilize stem cells successfully. These benefits have translated to post-transplantation complete remission rates that are significantly higher than what has ever been achieved before," said Professor Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu. "We know that high complete remission rates following transplantation lead to longer progression-free survival and overall survival. These data position VELCADE as an important therapy for front-line patients."
The multi-center, randomized Phase III trial is being conducted by the IFM cooperative group. The trial was designed to compare VELCADE in combination with dexamethasone to VAD as induction therapy prior to SCT in 480 newly diagnosed MM patients. The presentation during IMW included new data from 161 patients who received induction therapy, of which 137 patients received SCT. Results presented by Dr. Harousseau showed:
* As induction therapy prior to SCT, the VELCADE based therapy showed a CR rate of 20 percent compared to 7 percent for VAD.
* Following SCT, the VELCADE based therapy demonstrated a CR rate of 43 percent and a very good partial response + CR (VGPR + CR) rate of 75 percent. VAD showed a CR rate of 28 percent and a VGPR + CR rate of 46 percent following SCT.
* The VELCADE based therapy was well tolerated; the most common adverse events included neurologic toxicities, fever/infection and neutropenia.
Patients on the VELCADE based therapy received four standard cycles of VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle. Patients also received dexamethasone at 40 mg on days 1 through 4 during cycles one through four and on days 9 through 12 during cycles one and two only. Patients on VAD were treated for four cycles with vincristine at 0.4 mg/m2 on days 1 through 4; adriamycin at 9 mg/m2 on days 1 through 4; and dexamethasone 40 mg on days 1 through 4, days 9 through 12 during cycles one through four and on days 17 through 20 during cycles one and two only. Some patients received consolidation therapy. Response was assessed by the European Group for Blood and Marrow Transplant criteria. |
