VELCADE (bortezomib) Compared
to high-dose Dexamethasone in
Relapsed Multiple Myeloma:
A Phase III Randomized Study (APEX)
ASCO Press Briefing
Paul Richardson, M.D.
Dana Farber Cancer Institute
Saturday, June 5, 2004

Study Design
· Phase III APEX trial to assess VELCADE compared to high-dose
dexamethasone
· International, randomized, controlled study in patients with relapsed or
refractory multiple myeloma
One-to-three prior lines of therapy
669 patients enrolled at 94 centers
· End points
Primary: time to progression (TTP)
Secondary: survival, response rate (RR) and duration, time to skeletal
events (TSE), incidence of G3 infection, safety
Exploratory: quality of life (QOL), pharmacogenomics
· Companion crossover study provided VELCADE to patients progressing
on dexamethasone arm
· Patients refractory to high-dose dexamethasone were excluded from the
study

Time to Progression (Interim Analysis)
58% improvement in median TTP with VELCADE
Bortezomib
P < 0.0001
(n = 327)
ts
tiena
fPo
rtion
Dexamethasone
ropoP
(n = 330)
Months
Median TTP:
VELCADE arm 5.7 months
Dexamethasone arm 3. 6 months

Final Survival Analysis*
(Includes Crossover Patients)
Bortezomib (n = 333)
Patients
Dexamethasone (n = 336)
of
1 year
244 days median follow-up in survivors
Overall survival, P < 0.01
Proportion
-VELCADE: 48 deaths
-Dexamethasone: 81 deaths
1-year survival, P < 0.01
Time (days)
*January 13, 2004
· Risk of death in the first year reduced by ~30 percent in VELCADE arm
· Statistical significance held even with ~50% of patients crossing over
from dexamethasone arm to receive VELCADE

Document Outline