VELCADE(R) (Bortezomib) for Injection Based Therapies Show Consistently High Complete and Near complete Response Rates in Front-Line Multiple Myeloma Trials
Tuesday December 12, 9:00 am ET
ORLANDO, Fla., Dec. 12 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today reported the presentation of results of several clinical trials of VELCADE® (bortezomib) for Injection in combination with a variety of agents, including DOXIL® (pegylated liposomol doxorubicin) and dexamethasone, for the treatment of newly diagnosed multiple myeloma (MM) patients. Studies showed VELCADE combination therapy produced very good partial response and complete response (VGPR/CR) rates as high as 53 percent as induction therapy, which improved to 79 percent following autologous stem cell transplantation (ASCT). In a study of VELCADE in combination with dexamethasone, the one-year survival rate was 92 percent after a median follow up of 24 months. These findings were reported at the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH), December 9-12, 2006, in Orlando, Fla.
"Evidence continues to build that VELCADE based regimens provide high VGPR/CR rates in front-line patients as induction therapy prior to stem cell transplantation," said Nancy Simonian, M.D., Senior Vice President and Chief Medical Officer, Millennium. "With these high CR rates, we believe we are starting to see the benefit of VELCADE on improved post-transplant outcomes."
Long-Term Follow Up of Patients Treated with VELCADE (Bortezomib) Alone and in Combination with Dexamethasone as Front-line Therapy for Multiple Myeloma (Abstract #796)
The long-term follow up of a Phase II clinical trial evaluated VELCADE in combination with dexamethasone in 48 evaluable newly diagnosed MM patients. Patients with measurable disease received VELCADE at 1.3 mg/m2 on days 1, 4, 8, and 11 of a three-week cycle for up to six cycles. Oral dexamethasone at 40 mg was added to the treatment regimen on the day of and day after VELCADE for patients not achieving partial response (PR) after two cycles or for patients not achieving a CR after four cycles. Responses were assessed using modified European Group for Blood and Marrow Transplantation (EBMT) criteria. The study was presented by Sundar Jagannath, M.D., of St. Vincent's Comprehensive Cancer Center, New York, N.Y. on behalf of the Aptium Oncology Research Network, Los Angeles, Calif. Results showed:
-- Overall response rate (ORR) was 88 percent including an 18 percent
CR/near complete response (nCR) rate and a 20 percent VGPR rate
-- For all patients, with a median follow up of 27 months, median overall
survival had not yet been reached; one- and two-year survival rates
were 92 and 85 percent, respectively
-- For patients not proceeding to ASCT, with a median follow up of 27
months, two-year survival rate was 81 percent
-- Collection of stem cells was not impaired for patients proceeding to
ASCT
-- Therapy was well tolerated; the most frequent adverse events were
sensory neuropathy/neuropathic pain, fatigue and constipation
High Rate of Complete and near Complete Responses after Initial Therapy with VELCADE (Bortezomib), DOXIL, and Dexamethasone (VDD) Is Further Increased after Autologous Stem Cell Transplantation (Abstract #3093)
The Phase II clinical trial evaluated VELCADE in combination with DOXIL plus dexamethasone (VDD) in 28 evaluable newly diagnosed MM patients. The primary goals of the study were to measure CR/nCR of VDD pre- and post- transplantation and to explore whether an improved quality of response prior to ASCT would improve the overall chances of survival post-transplantation. Responses were assessed using modified EBMT criteria. Six three-week cycles of VELCADE at 1.3 mg/m2 were administered on days 1, 4, 8, and 11. DOXIL at 30 mg/m2 was administered on day four and dexamethasone at 40 mg on days one to four for the first 10 patients and at 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 for the remaining patients (for a total dose of 160 mg of dexamethasone per cycle). The data were presented by Andrzej Jakubowiak, M.D., Ph.D., of the University of Michigan Comprehensive Cancer Center in Ann Arbor, Mich. Results showed:
-- VDD achieved a strong ORR as induction therapy
- ORR was 89 percent, with a CR/nCR of 32 percent and with 53 percent
achieving a CR/VGPR
-- VDD appeared to improve probability of achieving CR/nCR and VGPR after
transplantation compared to results from randomized studies with single
or tandem transplantation
- In the 17 patients who went on to ASCT, ORR improved to 96 percent
with 54 percent achieving CR/nCR and 79 percent achieving a CR/VGPR
- Collection of stem cells was not impaired by this regimen
-- The most common adverse events were fatigue, pneumonia/infection and
neuropathy (only mild)
VELCADE (Bortezomib) and Pegylated Liposomal Doxorubicin as Induction Therapy for Adult Patients with Symptomatic Multiple Myeloma: Cancer and Leukemia Group B Study 10301 (Abstract #797)
The multicenter Phase II study assessed the safety and efficacy of the steroid-free combination of VELCADE and DOXIL in 57 evaluable newly diagnosed MM patients as induction therapy prior to ASCT. Responses were assessed using modified EBMT. VELCADE was administered at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle, along with DOXIL at 30 mg/m2 on day four, for a maximum of eight cycles. Data from 29 evaluable patients were presented by Robert Orlowski, M.D., Ph.D., of the University of North Carolina at Chapel Hill for the Cancer and Leukemia Group B cooperative group. Results showed:
-- After induction therapy prior to stem cell transplantation, ORR was 79
percent with a 28 percent CR/nCR rate
-- Treatment did not affect stem cell collection in patients evaluable for
this endpoint
-- Therapy was well tolerated; the most common adverse events were
neutropenia, thrombocytopenia (hematologic), fatigue and sensory
neuropathy (non-hematologic)
VELCADE is the U.S. market leader for relapsed MM. Previous studies in relapsed MM have demonstrated single-agent VELCADE has unprecedented survival. In newly diagnosed patients, VELCADE based therapies have achieved transplant- like results with ORRs of up to 95 percent and CR/nCR rates of up to 43 percent. The studies presented today along with the interim data from the Phase III trial presented by the Intergroupe Francophone du Myelome on Sunday continue to show some of the highest recorded CR/nCR rates for a therapeutic agent in the treatment of front-line MM. |
