VELCADE(R) (bortezomib) for Injection Continues to Show Impressive Results in a Variety of Lymphomas
prnews
ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today announced the results from phase II studies
evaluating the efficacy and safety of VELCADE in patients with aggressive and
indolent subtypes of non-Hodgkin's lymphoma (NHL). The results show high
response rates, favorable safety and dosing with VELCADE as a single-agent and
in combination therapy. These findings were reported in independent oral
presentations at the 47th Annual Meeting of the American Society of Hematology
(ASH) being held December 10-13, 2005, in Atlanta, GA.
"The efficacy and safety results presented here on VELCADE alone and in
combination with other standard therapies, such as rituximab, show the
potential of VELCADE to treat a broad range of lymphomas, including mantle
cell and follicular lymphomas," said David Schenkein, M.D., senior vice
president, clinical development, Millennium. "These findings have led
Millennium and co-developer Johnson & Johnson Pharmaceutical Research &
Development, to pursue additional clinical studies in non-Hodgkin's lymphoma,
including a phase III trial of once-weekly VELCADE plus rituximab versus
rituximab alone in follicular lymphoma, expected to begin in the second half
of 2006."
VELCADE Combination with Rituximab (abstract #17)
The randomized, multi-center phase II study, led by Andre Goy, M.D., of
Hackensack University Medical Center in Hackensack, and Sven de Vos, M.D.,
Ph.D., of UCLA Medical Center in Los Angeles, evaluated weekly (1.6mg/m2) and
twice-weekly (1.3mg/m2) dosing of VELCADE in combination with the standard-
weekly dose of rituximab in patients with relapsed and refractory indolent B-
cell lymphomas. The more convenient weekly regimen showed a similar response
rate to the twice-weekly arm with an improved safety profile. Results from the
74 evaluable patients (39 in the weekly arm and 35 in the twice-weekly arm)
included:
* Overall response rates of 54% in the weekly arm, and 51% in the twice-
weekly arm with a higher total amount of drug received in the weekly
arm
* The combination was well tolerated in each study arm
* The most common adverse events were gastrointestinal symptoms,
neutropenia, thrombocytopenia and peripheral neuropathy; adverse events
were less frequent in the weekly arm with no grade 3 or 4
thrombocytopenia
"These results are encouraging with similar response rates in both arms,"
said Dr. de Vos. "The weekly schedule for VELCADE and rituximab appears
promising with more convenience to patients, while maintaining efficacy and
safety. These data support the decision to initiate a phase III study in
follicular lymphoma in the near future."
VELCADE Combination with CHOP Plus Rituximab (abstract #491)
Results from a phase I/II study of VELCADE in combination with standard
cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) plus
rituximab for the treatment of previously untreated patients with diffuse
large B-cell (DLBCL) and mantle cell lymphomas (MCL) were presented by John P.
Leonard, M.D., of Weill Medical College of Cornell University/New York
Presbyterian Hospital in New York. With a median follow-up of 13 months, data
from the phase I cohort of 20 patients (16 DLBCL, four MCL) showed:
* Overall response rate (complete plus partial responses) of 95%
-- 85% complete response or complete response unconfirmed by biopsy
-- 80% of patients currently alive without progression
* Treatment was generally well tolerated; only one patient had grade 3/4
peripheral neuropathy
* The phase II study has enrolled 44 patients and is ongoing
Single-Agent VELCADE in Waldenstrom's Macroglobulinemia (abstract #490)
Results from a phase II study of single-agent VELCADE in patients with
Waldenstrom's macroglobulinemia, a form of indolent lymphoma, were presented
by Steven Treon, M.D., Ph.D., of Dana Farber Cancer Institute in Boston.
Results from 27 evaluable patients included:
* Overall response rate of 85%
-- 44% of patients achieved a major response
-- 41% of patients achieved a minor response
* Patients recieved a median of 6 cycles and 41% recieved all 8 cycles
* Therapy was well tolerated; the most common adverse events included
neutropenia, thrombocytopenia and sensory neuropathies
About Non-Hodgkin's Lymphoma (NHL)
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer and
the fifth leading cause of cancer death in the U.S. There are approximately
56,400 new cases diagnosed per year, it is responsible for 19,200 deaths
annually and is the second fastest growing form of cancer in the U.S.(1) The
prevalence of NHL is approximately 400,000, including 77,000 patients with
follicular lymphoma and approximately 10,000 with mantle cell lymphoma.(2),(3)
According to the American Cancer Society, the incidence of NHL has more than
doubled since the 1970s. The average age of diagnosis is between 55 and 60.
About VELCADE
[SNIP] |
