VELCADE(R) (Bortezomib) for Injection Based Therapies Produced Complete Remission Rates as High as 54 Percent in Patients With Previously Treated Multiple Myeloma
Thursday June 28, 11:00 am ET
[Maybe Velcade or Revlimid is not at all the right question to ask]
- 100 percent of patients treated with VELCADE, cyclophosphamide, and prednisone alive at one year -
KOS, Greece, June 28 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today reported on the presentation of results from clinical trials of VELCADE based therapies that showed high complete remission / complete response(1) (CR) rates in previously treated multiple myeloma (MM) patients. These findings were presented at the prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece. Highlights included:
-- VELCADE, cyclophosphamide and prednisone (VCP) demonstrated an overall response rate (ORR) of 93 percent including a CR(1) rate of 54 percent. At one year, 100 percent of patients were alive.
-- VELCADE, lenalidomide and dexamethasone (VRD) showed an ORR of 68 percent with a 5 percent CR(1) rate in a pilot study of heavily pretreated patients, including those who had been previously treated with VELCADE or lenalidomide.
"By combining the power of VELCADE with other active agents, we are seeing some of the strongest reported efficacy in previously treated multiple myeloma patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The wealth of combination data that are being generated promises to strengthen the U.S. market-leading role of VELCADE."
Weekly VELCADE, Cyclophosphamide and Prednisone in Myeloma (Abstract #PO- 639)
"VELCADE has shown synergistic activity with alkylating agents by generating substantially high and durable complete remission rates," said Donna Reece, M.D., Princess Margaret Hospital. "This is an important finding for the field of multiple myeloma and leads us to believe that the combination of VELCADE and cyclophosphamide warrants further investigation in the front-line setting with the goal of prolonging patients' survival."
The Phase II study was designed to evaluate the efficacy and safety of VCP in relapsed / refractory MM patients. The study included 13 evaluable patients, who received VELCADE at 1.5 mg/m2 on days 1, 8 and 15 of a 28-day schedule. Patients also received 300 mg/m2 of cyclophosphamide on days 1, 8, 15 and 22 and prednisone at 100 mg every two days. Patients were treated for up to eight cycles. Response was assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria. Results were presented by Dr. Reece and showed an ORR (CR + partial response + minor response) of 93 percent, including a high CR rate of 54 percent. At one year, all patients were alive (one-year survival rate). Therapy demonstrated excellent patient tolerance with side effects similar to those seen with each agent alone.
Phase II Study of VELCADE, Lenalidomide and Dexamethasone in Relapsed / Refractory Multiple Myeloma (Abstract #PO-660)
The Phase II multi-center study evaluated the efficacy and safety of this novel combination therapy. The trial included 19 evaluable relapsed / refractory MM patients, including those who had received prior VELCADE, lenalidomide, thalidomide or stem cell transplantation. The patients received VELCADE at 1.0 mg/m2 on days 1, 4, 8 and 11 of a 21-day schedule; lenalidomide at 15 mg on days 1 through 14; and dexamethasone at 40 mg for cycles one through four and 20 mg for cycles five through eight. Patients received a median of five cycles. Responses were assessed using the EBMT criteria. Results were presented by Paul Richardson, M.D., Dana-Farber Cancer Institute, and showed a 68 percent ORR, including a CR rate of 5 percent. Therapy was well tolerated with no grade 3 or higher toxicities. |
