POMALYST ® (pomalidomide) is a thalidomide
analogue indicated, in combination with
dexamethasone, for patients with multiple
myeloma who have received at least two
prior therapies including lenalidomide and a
proteasome inhibitor and have demonstrated
disease progression on or within 60 days of
completion of the last therapy.
POMALYST + low-dose dex signifi cantly prolonged overall survival
• Hazard ratio 0.70 (95% CI: 0.54, 0.92; P =0.009) vs high-dose dex
1.0
Overall survival (ITT population)
0.8
POMALYST + low-dose dex
High-dose dex
0.6
0.4
0.2
Hazard ratio (95% CI) 0.70 (0.54, 0.92)
Log-rank P-value=0.009 (2-sided)
Data cutoff: March 1, 2013
Kaplan Meier median: POMALYST + low-dose dex=12.4 [10.4, 15.3]
Kaplan Meier median: high-dose dex=8.0 [6.9, 9.0]
Events: POMALYST + low-dose dex=147/302; high-dose dex=86/153
0.0
0
3
6
9
12
15 18 21 24
0
Overall survival, months
Number of patients at risk:
POMALYST +
low-dose dex 302 248 199 126 71 32 12 1
High-dose
dex 153 112 84 44 24 11 3 0
CI, confi dence interval; ITT, intent-to-treat.
POMALYST + low-dose dex is the only approved therapy that has
an OS benefi t in patients with relapsed/refractory myeloma who
failed REVLIMID ® (lenalidomide) and bortezomib
Progression-free survival (primary endpoint) was signifi cantly longer with POMALYST
+ low-dose dex vs high-dose dex
• Hazard ratio 0.45 (95% CI: 0.35, 0.59; P <0.001)
Study Design: Phase 3 multicenter, randomized, open-label study, where POMALYST + low-dose dex was
compared with high-dose dex in patients with relapsed and refractory multiple myeloma, who had received at
least 2 prior treatment regimens, including REVLIMID and bortezomib, and demonstrated disease progression
on or within 60 days of the last therapy (ITT population, N=455). Key exclusion criteria: Serum bilirubin >2.0 mg/dL,
AST/ALT >3.0 x upper limit of normal, creatinine clearance <45 mL/min. Patients in the POMALYST + low-dose dex
arm (n=302) were administered 4 mg POMALYST orally on Days 1-21 of each 28-day cycle. Low-dose dex (40 mg a )
was administered once per day on Days 1, 8, 15, and 22 of a 28-day cycle. For the high-dose dex arm (n=153),
dex (40 mg a ) was administered once per day on Days 1-4, 9-12,
and 17-20 of a 28-day cycle. Treatment continued until patients
had disease progression.
a Patients >75 years of age started treatment with 20 mg dex using the same schedule.
In the Phase 3 trial, OS was based on the assessment by the
Independent Review Adjudication Committee (IRAC) review
at the fi nal OS analysis.