Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today announced the presentation of positive data for
VELCADE, the market-leading therapy for patients with multiple myeloma (MM)
who have received at least one prior therapy. These data include results
from a Phase II trial for subcutaneous (SC) administration of VELCADE, a
new option under evaluation. Results were also presented from the
international Phase III trial of VELCADE + DOXIL, which served as the basis
for the recent U.S. approval of the combination and showed significant
improvement in time to disease progression compared to VELCADE alone, the
current standard of care. The VELCADE + DOXIL abstract was selected by the
Best of the American Society of Clinical Oncology (ASCO) Program Committee
as one of the premier abstracts at the 43rd Annual Meeting in Chicago.
"We and our partner Johnson & Johnson Pharmaceutical Research and
Development L.L.C. continue to develop new clinical data that reinforce the
role of VELCADE as the U.S. market-leading therapy in previously treated
multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer,
Millennium. "These data demonstrate that VELCADE in combination with
another active agent can further strengthen the unparalleled impact of
VELCADE. We are aggressively pursuing development of a subcutaneous
delivery form to broaden alternatives for patients who prefer to receive
VELCADE treatment at home."
Prospective Comparison of Subcutaneous to Intravenous Administration of
Bortezomib in Patients with Multiple Myeloma: Pharmacokinetics, Efficacy
and Toxicity (Abstract #8046)
This randomized trial evaluated the pharmacokinetics/pharmacodynamics
(PK/PD), toxicity and response rate of VELCADE in patients treated with
either an SC or intravenous (IV) administration option. Results were
presented by Philippe Moreau, M.D., University Hospital Hotel-Dieu and
showed:
-- Similar bioavailability for the two routes of administration
-- Similar safety and tolerability profiles for the two routes of
administration with a trend favoring the SC route as evidenced by fewer
patients in this group discontinuing therapy
-- Identical response rates for the two routes of administration with both
groups of patients achieving an overall response rate (complete and
partial response) of 42 percent
The trial included 24 patients who were randomized to receive either SC
or IV injections of VELCADE at the standard dose of 1.3 mg/m2 twice weekly
for two weeks on days 1, 4, 8 and 11 with one week rest for up to eight
cycles. Blood samples were taken on days 1 and 11 to measure PK by plasma
Cmax (maximum plasma concentration), AUC (area under plasma
concentration-time curve) and Tmax (time to Cmax) values and to measure PD
by AUE (area under effect curve) and Emax (maximum effect) values. Patients
received a median number of six and five cycles in the IV and SC groups,
respectively.
Effect of the Combination of Pegylated Liposomal Doxorubicin and
Bortezomib on Time to Progression (TTP) and Overall Survival of Patients
With Relapsed/Refractory Multiple Myeloma Compared With Bortezomib Alone
(Abstract #8002)
"The combination of VELCADE + DOXIL is highly active, with the time to
disease progression the strongest in any U.S.-approved label for this
patient population," said Jean-Luc Harousseau, M.D., University Hospital
Hotel-Dieu. "Based on the Phase II trial, which showed a median overall
survival greater than 38 months, we believe that the strong efficacy of the
combination in the Phase III trial will extend to a substantial improvement
in overall survival as well."
The Phase III study compared the efficacy and safety of the combination
of VELCADE + DOXIL to VELCADE monotherapy, the standard of care in patients
with previously treated MM. Results were presented by Dr. Harousseau and
showed:
-- A survival advantage was observed for the VELCADE + DOXIL combination,
after approximately 20 percent of events occurred (p