VELCADE(R) (Bortezomib) for Injection Based Therapies Achieved Survival Rates as High as 100 Percent in Newly Diagnosed Multiple Myeloma Patients
Thursday June 28, 10:00 am ET
-- 100 percent response rate achieved with VELCADE, lenalidomide and dexamethasone --
KOS, Greece, June 28 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today reported on the presentation of results from four clinical trials of VELCADE based therapies that showed consistently high survival and complete remission / complete response(1) (CR) rates in newly diagnosed multiple myeloma (MM) patients. These data were presented at the prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece. Highlights included:
-- VELCADE, melphalan and prednisone (VMP) demonstrated a CR(1) rate of 43 percent, the strongest rate ever reported for a melphalan prednisone combination therapy. At 38 months, 85 percent of patients were alive. This is the highest reported three-year survival rate in the front-line treatment setting.
-- VELCADE, adriamycin and dexamethasone (referred to as VcAD or PAD) showed a CR(1) rate of 29 percent prior to stem cell transplantation (SCT), which further improved to 57 percent following SCT. At one year, 100 percent of patients were alive, and at two years, 95 percent of patients were alive. This is the highest reported two-year survival rate in the front-line treatment setting. Median overall survival (OS) has not yet been reached after four years.
-- VELCADE, DOXIL® (pegylated liposomal doxorubicin) and dexamethasone (VDD) showed a CR(1) rate of 43 percent prior to SCT, which increased to 65 percent following SCT. At 16 months, 100 percent of patients were alive.
-- VELCADE, lenalidomide and dexamethasone (VRD) showed an overall response rate (ORR) of 100 percent, including a CR(1) rate of 20 percent.
"These spectacular results underscore the crucial role of VELCADE in front-line multiple myeloma," said Sagar Lonial, M.D., Emory University. "VELCADE has consistently delivered survival rates that are among the highest seen to date in this disease setting. These high survival rates were driven by the substantial complete remission rates seen when VELCADE has been added to multiple therapies. Oncologists generally use the most efficacious agents as front-line treatment to maximize outcomes for patients, and as such, VELCADE will be a leading therapy in this disease setting."
Frontline VMP in Elderly Multiple Myeloma Patients: Extended Follow-Up (Abstract #PO-718)
"The addition of VELCADE has produced the best complete remisssion and three-year survival rates ever reported with a melphalan prednisone therapy, providing results that are as powerful as stem cell transplantation without the associated side effects, recovery time and expense," said Maria-Victoria Mateos, M.D., Ph.D., Grupo Espanol de Multiple Myeloma. "With VELCADE added to this combination, we now are able to offer all patients, including those who historically could not have a transplant, an alternative that provides complete remission and prolongs lives."
The Phase I / II study evaluated efficacy and safety of VMP combination therapy in untreated MM patients aged 65 years or older with a median age of 75 years. The study included 54 evaluable patients ineligible for SCT. Patients received VELCADE at 1.0 mg/m(2) or 1.3 mg/m(2) on days 1, 4, 8, 11, 22, 25, 29 and 32 for four six-week cycles, then on days 1, 8, 15 and 22 for five five-week cycles. Patients also received melphalan at 9 mg/m(2) and prednisone at 60 mg/m(2) on days 1 through 4 of each cycle. Response was assessed using the European Group for Blood and Marrow Transplant (EBMT) criteria. Results were presented by Dr. Mateos and showed a CR rate of 43 percent. At 38 months, 85 percent of patients were alive. Side effects were predictable and manageable, similar to those seen in previous VELCADE clinical trials.
Long Term Follow-Up of VcAD (or PAD) for Untreated Multiple Myeloma (Abstract #PO-725)
The open-label Phase I / II study investigated the efficacy of VcAD combination therapy in untreated MM patients. The trial included 40 evaluable patients, who were treated for four cycles prior to SCT. Patients received either VELCADE at 1.3 mg/m(2) (VcAD-1) or 1.0 mg/m(2) (VcAD-2) on days 1, 4, 8 and 11 of a 21-day schedule. Patients also received doxorubicin at 9 mg/m(2) on days 1 through 4 and dexamethasone at 40 mg on days 1 through 4, 8 through 11, and 15 through 18 during cycle one and on days 1 through 4 during cycles two through four. Responses were classified using the EBMT criteria. Results were presented by Rakesh Popat, M.D., St. Bartholomew's Hospital, and showed in the VcAD-1 arm a CR rate of 29 percent prior to SCT, which improved to 57 percent following SCT. At one year, 100 percent of patients were alive with 95 percent of patients alive at two years. Median OS has not yet been reached after four years. Side effects, including peripheral neuropathy, were predictable and manageable, similar to those seen in previous VELCADE clinical trials.
Combination Therapy with VELCADE, DOXIL and Dexamethasone in Newly Diagnosed Myeloma: Updated Results of a Phase II Clinical Trial (Abstract #PO- 721)
The Phase II trial evaluated the efficacy of VDD combination therapy in untreated MM patients. The trial enrolled 40 patients, who received VELCADE at 1.3 mg/m(2) on days 1, 4, 8 and 11 of a 21-day schedule. Patients also received DOXIL at 30 mg/m(2) on day 4 and dexamethasone at 40 mg on days 1 through 4 or 20 mg corresponding with the VELCADE schedule. After four cycles of VDD, patients proceeded to SCT or continued VDD maintenance therapy. Responses were determined based on the EBMT criteria. Results were presented by Andrzej Jakubowiak, M.D., Ph.D., University of Michigan Comprehensive Cancer Center, and demonstrated a CR rate of 43 percent prior to SCT, which improved to 65 percent following SCT. At 16 months, 100 percent of patients were alive. Side effects were predictable and manageable, similar to those seen in previous VELCADE clinical trials.
Phase I / II Study of Upfront VELCADE, Lenalidomide and Dexamethasone in Multiple Myeloma: Early Results (Abstract #PO-715)
This Phase I / II study of VRD combination therapy was designed to determine the maximum tolerated dose (MTD) and efficacy in untreated MM patients. The preliminary analysis included 15 evaluable patients, who received VELCADE at 1.0 mg/m(2) or 1.3 mg/m(2) on days 1, 4, 8 and 11 of a 21- day schedule. Patients also received lenalidomide at 15, 20 or 25 mg on days 1 through 14 and dexamethasone at 40 mg corresponding with the VELCADE schedule. Patients were treated for up to eight cycles at four planned dose levels. MTD has not yet been reached. Response was assessed by modified EBMT criteria. Results were presented by Paul Richardson, M.D., Dana-Farber Cancer Institute, and showed an ORR (CR + partial response + minor response) of 100 percent, including a CR rate of 20 percent. Side effects were manageable and included hypophosphatemia, infections and thrombocytopenia. No grade 3 or higher peripheral neuropathy was observed. |
