VELCADE(R) (Bortezomib) for Injection Demonstrates Substantial Activity Across Range of Lymphomas
Monday December 11, 4:15 pm ET
[PR from Millennium is almost like spam these days]
- Phase II trials report high overall response rates in relapsed patients -
ORLANDO, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today reported overall response rates (ORR) as high as 75 percent from Phase II clinical trials of VELCADE® (bortezomib) for Injection combination therapy across four subtypes of non-Hodgkin's lymphoma (NHL): follicular, marginal zone, mantle cell lymphoma (MCL) and T-cell lymphoma. These data include positive results from the Phase II study of VELCADE in combination with rituximab in follicular lymphoma, which served as the basis for an ongoing Phase III registration-enabling trial initiated earlier this year. The findings were presented at the 48th Annual Meeting of the American Society of Hematology (ASH) being held December 9-12, 2006, in Orlando, Fla.
"These results build on the strong single-agent activity previously seen with VELCADE in NHL and represent a significant step forward in accelerating and expanding the development of VELCADE in combination for the treatment of a variety of lymphomas," said Andy Boral, M.D., Ph.D., Senior Medical Director, Millennium. "Our recent approval in MCL demonstrates the ability of VELCADE to provide significant benefit to patients, even with the most aggressive types of lymphoma, and may lead to the establishment of a new standard of care."
VELCADE received full approval from the U.S. Food and Drug Administration (FDA) on December 8, 2006 for treatment of patients with MCL who have received at least one prior therapy, marking the first indication for VELCADE in lymphoma and the first therapy to receive FDA approval in this treatment setting.
Phase II Study of VELCADE (Bortezomib) Weekly or Twice Weekly Plus Rituximab in Patients with Follicular or Marginal Zone Lymphoma: Final Results (Abstract #694)
The multicenter Phase II study evaluated the safety and efficacy of VELCADE in combination with rituximab in 81 patients with follicular or marginal zone lymphoma. Response was evaluated by independent radiology review and by investigator assessment using the International Workshop Response Criteria (IWRC). Patients were randomized to receive either four weekly VELCADE doses at 1.6 mg/m2 on a 35-day cycle or twice-weekly VELCADE at 1.3 mg/m2 on a 21-day cycle. All patients received weekly rituximab at its regular weekly dose of 375 mg/m2 for four weeks. Patients were treated for a maximum of three cycles in the weekly VELCADE arm and five cycles in the twice-weekly VELCADE arm. The data were presented by Sven de Vos, M.D., Ph.D., of UCLA Medical Center in Los Angeles, Calif. Final results showed:
* By investigator assessment using the IWRC:
-- ORR (complete response [CR], complete response unconfirmed [CRu] and
partial response [PR]) was 53 percent among patients treated with
once-weekly VELCADE and 57 percent among patients treated in the
twice-weekly arm
-- Median time to progression (TTP) was nine months among patients
treated with once- weekly VELCADE and 9.9 months among patients
treated with twice-weekly VELCADE
* By independent radiology review:
-- ORR was 38 percent among patients treated with weekly VELCADE and 46
percent treated with twice-weekly VELCADE
-- Median TTP was 9.7 months among patients treated with VELCADE weekly
and 5.2 months among patients treated with VELCADE twice-weekly
* The total amount of VELCADE received was similar in both arms
* Therapy was well tolerated; the most common adverse events with both
weekly and twice-weekly VELCADE were fatigue, gastrointestinal events
and peripheral neuropathy
* The weekly dosing schedule was determined to have similar efficacy to
the twice-weekly schedule with the additional benefits of fewer grade 3
and 4 toxicities and a more convenient dosing schedule
* Based on these results, a randomized Phase III trial of VELCADE in
combination with rituximab compared to rituximab alone was initiated
earlier this year under a Special Protocol Assessment with the FDA
Marked Activity of VELCADE (Bortezomib), Rituximab and Dexamethasone in Relapsed and Refractory Mantle Cell Lymphoma (Abstract #2753)
The single-arm Phase II study evaluated the efficacy and safety of VELCADE in combination with rituximab and dexamethasone in 12 evaluable patients with relapsed MCL. VELCADE at 1.3 mg/m2 was administered on days 1, 4, 8 and 11, rituximab at 375 mg/m2 was administered on day 1, and oral dexamethasone at 40 mg was administered on days one through four. Cycles were repeated every three-weeks for six cycles. The study was presented by Johannes Drach, M.D., of the Medical University of Vienna, Austria. Results showed:
* ORR was 75 percent with 25 percent of patients achieving a CR
* All patients who achieved CR were progression free at 12 months
* Therapy was well tolerated; the most common adverse events included
infections, peripheral neuropathy and fatigue
Phase II Study of Proteasome Inhibitor VELCADE (Bortezomib) in Patients with Relapsed/Refractory T-cell Lymphoma: Preliminary Results (Abstract #2462)
The Phase II study evaluated the efficacy and safety of single-agent VELCADE in 12 evaluable previously treated patients with peripheral T-cell lymphoma. Response was assessed using the National Cancer Institute Working Group criteria. VELCADE was administered at 1.3 mg/m2 on days 1, 4, 8 and 11 during a 21-day cycle for up to six cycles. The study was led by Pier Luigi Zinzani, M.D., Unit of Cardiology and Hematology, Institute of Hematology and Medical Oncology, University of Bologna, Bologna, Italy. Interim results showed:
* ORR was 67 percent including 17 percent of patients achieving a CR
* Treatment was well tolerated; the most frequent adverse events were
neutropenia, thrombocytopenia and peripheral neuropathy
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 10,000 with mantle cell lymphoma. There are approximately 54,000 new cases of NHL diagnosed per year, and 19,000 deaths are attributed to the disease annually(2,3).
Mantle cell lymphoma is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. Because there is no generally accepted treatment approach and options often are limited, there is a growing need for new therapies. The average life expectancy for a patient with relapsed mantle cell lymphoma is one year. |
