IN PATIENTS WHO RECEIVED REVLIMID (lenalidomide) AND A PI
POMALYST + dex: A doublet therapy
built on a FOUNDATION of POMALYST 2
PROVEN OVERALL SURVIVAL (ITT POPULATION, N=455)*
1.0
POMALYST +
low-dose dex
HR 0.70; 95% CI 0.54, 0.92; P=0.009
Median OS vs high-dose dex
High-dose dex
0.8
0.6
12.4 months
(95% CI 10.4, 15.3)
0.4
0.2
8.0 months
(95% CI 6.9, 9.0)
0.0
0
3
6
Number of patients at risk:
POMALYST +
low-dose dex
High-dose dex
302
153
248
112
199
84
9
12
15
18 21 24
12
3 1
0 0
Overall survival, months
126
44
71
24
32
11
OS events: POMALYST + low-dose dex = 147/302; high-dose dex = 86/153
OS was based on the assessment by the Independent Review Adjudication Committee (IRAC)
review at the fi nal OS analysis.
POMALYST + low-dose dex doubled the median PFS of high-dose dex (primary endpoint)
• Median PFS was signifi cantly longer with POMALYST + low-dose dex vs high-dose dex
(3.6 vs 1.8 months; HR 0.45; 95% CI 0.35, 0.59; P<0.001)
The POMALYST doublet: Proven results after
REVLIMID and a PI 2
Trial Design: POMALYST was studied in a phase 3 multicenter, randomized, open-label study of POMALYST + low-dose dex vs
high-dose dex in patients with relapsed/refractory myeloma who had received ≥2 prior treatment regimens, including REVLIMID
and bortezomib, and demonstrated disease progression ≤60 days from the last therapy (ITT population, N=455). Key exclusion
criteria included serum bilirubin >2.0 mg/dL, AST/ALT >3.0x upper limit of normal, and CrCl <45 mL/min.
Patients in the POMALYST + low-dose dex arm (n=302) received 4 mg of
POMALYST on Days 1-21 of 28-day cycles with 40 mg of low-dose dex once
daily on Days 1, 8, 15, and 22. Patients in the high-dose dex arm (n=153)
received 40 mg of dex once daily on Days 1-4, 9-12, and 17-20 of 28-day
cycles. Patients >75 years received 20 mg of dex in the same respective
dosing schedules. Patients receiving POMALYST + low-dose dex were required
to receive prophylaxis or anti-thrombotic treatment, as well as any other
patient with a history of DVT or PE. The primary endpoint was PFS. Treatment
continued until disease progression. 1,3