Note that one of the studies is of V with Revlimid after some of the patients were refractory to R itself, and all were refractory to something.
VELCADE(R) (bortezomib) for Injection Single-Agent and Combination Studies Show Positive Outcomes in a Broad Range of Multiple Myeloma Patients
ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today announced positive results in a broad range of
multiple myeloma populations exploring the use of VELCADE alone and in
combination with other therapies. These studies show, despite poor prognostic
factors, overall response rates up to 78 percent in relapsed and refractory
multiple myeloma patients, a population in which the landmark phase III APEX
trial has already demonstrated a median 30-month survival benefit for VELCADE
as a single agent. The data were presented at the 47th Annual Meeting of the
American Society of Hematology (ASH) being held December 10-13, 2005 in
Atlanta, GA.
"The findings from these studies are exciting, most notably the high
response rate and favorable safety profile of VELCADE in patients with renal
failure, a condition which effects up to 50 percent of all multiple myeloma
patients experience at some stage of their disease(1)," said David Schenkein,
M.D., senior vice president, clinical development, Millennium. "Other studies
show mounting evidence of VELCADE activity in patients with other poor
prognostic factors such as chromosome 13 deletion."
VELCADE Multi-Center Retrospective Review of Relapsed Patients with Renal
Failure (abstract #2550)
A multi-center, retrospective review of the safety and efficacy of VELCADE
based therapy in relapsed multiple myeloma patients with renal failure
requiring hemodialysis was conducted by Asher Alban Chanan-Khan, M.D., of the
Roswell Park Cancer Institute in Buffalo. Data from 24 evaluable patients
showed:
* Overall response rate of 78% was achieved with single-agent VELCADE and
various VELCADE based combinations, with 33% of patients achieving
a complete or near-complete response with a median of 7.5 cycles
* Three patients achieved a complete response and did not require
dialysis
* VELCADE at full dose was generally well tolerated with manageable side
effects; serious adverse events were rare, and did not appear to be
increased compared to patients with normal renal function
"Patients with relapsed, refractory multiple myeloma often present with
renal failure which can greatly impact their ability to tolerate treatment,"
said Dr. Chanan-Khan. "These results suggest that VELCADE may enable us to
overcome this challenge and offer a much needed treatment option for these
patients."
VELCADE Single-Agent in Patients with Chromosome 13 Deletion (abstract
#509)
A retrospective analysis, conducted by Johannes Drach, M.D., at the
Medical University of Vienna in Austria, evaluated the efficacy of VELCADE
with poor prognostic factors, in particular chromosomal abnormalities,
including chromosome 13 deletion. The objectives of the study were to assess
response rate, time to treatment failure (TTF/TTP), and overall survival.
Patients had received a median of three prior therapies. Results from 51
evaluable patients showed:
* Overall response rates, including complete and near-complete response
rates, and duration of response were independent of chromosome 13 status
* In patients with the chromosome 13 deletion, overall response rate was
50% with 23% of patients achieving a complete response and a 10.4-month
duration of response
* Median overall survival was 15 months and also independent of chromosome
13 status
* Response rate and overall survival were also independent of other poor
prognostic factors including 14q abnormality and Beta-2 microglobulin
level
"The important observation is that with VELCADE treatment, we do not see a
difference in response rate or duration of response for patients with and
without a 13q deletion," said Dr. Drach. "This is different from the
experience with chemotherapy and even transplantation."
VELCADE with Lenalidomide in Relapsed and Refractory Patients (abstract
#365)
An ongoing, phase I trial conducted by Paul Richardson, M.D., of the Dana-
Farber Cancer Institute in Boston evaluated the maximum-tolerated dose of
VELCADE and lenalidomide in patients with relapsed and/or refractory multiple
myeloma. Data from 21 evaluable patients showed:
* Overall response rate (includes complete, partial and minor responses)
of 67%
-- Two patients achieved complete or near-complete responses
-- Nine achieved partial responses
* Patients were heavily pretreated with a median of five prior therapies,
including: VELCADE (50%), thalidomide (80%), lenalidomide (10%) and stem
cell transplant (40%)
* Median of seven cycles were completed; maximum-tolerated dose has not
yet been reached
* Most common adverse events for the combination were thrombocytopenia
and neutropenia, but were very manageable
About Multiple Myeloma (MM)
[SNIP] |
