POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult 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 + DEX
Proven overall survival benefit vs high-dose dex.1,2
(Secondary endpoint)
OS (ITT POPULATION, N=455)
POMALYST + LOW-DOSE DEX
Reduced risk of death vs high-dose dex
Median OS: 12.4 months (95% CI 10.4, 15.3) vs 8.0 months (95% CI 6.9, 9.0) (HR 0.70; 95% CI 0.54, 0.92; P=0.009)
Data cutoff: March 1, 2013.
POMALYST® (pomalidomide) + dex improved median overall
survival vs high-dose dex in the doublet Phase 3 trial.1

In the Phase 3 trial, OS was based on the assessment by the Independent Review Adjudication Committee (IRAC) review at the final OS analysis.1
POMALYST + low-dose dex doubled the median
progression-free survival of high-dose dex (primary endpoint).1
- Median PFS was significantly longer with POMALYST + low-dose dex vs high-dose dex (3.6 vs 1.8 months; HR 0.45; 95% Cl 0.35; 0.59; P<0.001)

In the Phase 3 trial, PFS was based on the assessment by the IRAC review at the final PFS analysis.1
OS subgroup analysis included POMALYST + dex immediately after REVLIMID® (lenalidomide).3*

Analysis limitations
- These exploratory analyses should not be interpreted to determine a treatment difference between arms in these select subgroups because of potential selection bias, insufficient sample size, and a higher probability of making a false-positive finding
CI, confidence interval; HR, hazard ratio; IRAC, Independent Review Adjudication Committee; ITT, intent-to-treat; OS, overall survival; PFS, progression-free survival; PI, proteasome inhibitor.
*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.
References: 1. POMALYST [package insert]. Summit, NJ: Celgene Corp. 2. San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomized, open-label, phase 3 trial. Lancet Oncol. 2013;14(11)1055-1066. 3. Data on file. Bristol-Myers Squibb Co; 2018.