POMALYST® (pomalidomide) is indicated for patients with multiple myeloma who have received at
least two prior therapies including lenalidomide and bortezomib and have demonstrated disease
progression on or within 60 days of completion of the last therapy. Approval is based on response
rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
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Overall response rate (ORR) of 29.2% was achieved with all-oral POMALYST + low-dose dex
ORR (≥PR)
100%
Patients, %
80%
95% CI for ORR:
POMALYST: 3.3% to 14.1%
POMALYST + low-dose dex: 21.0% to 38.5%
60%
40%
20%
0%
ORR 7.4%
(n=8)
POMALYST
(n=108)
PR 7.4%
(n=8)
CR 0%
(n=0)
ORR 29.2%
(n=33)
PR 28.3%
(n=32)
CR 0.9%
(n=1)
POMALYST + low-dose dex
(n=113)
CI, confidence interval; CR, complete response; Dex, dexamethasone; PR, partial
response. Endpoint based on responses assessed by IRAC, based on EBMT criteria.
Study design: A phase 2,
multicenter, randomized
open-label study in patients
who were refractory to their
last myeloma therapy and
had received lenalidomide
and bortezomib. The safety
and efficacy of POMALYST
4 mg 21/28 days until disease
progression was evaluated
alone and in combination
with low-dose dex: 40 mg
per day (patients ≤75 years)
or 20 mg per day (patients
>75 years) only on Days 1,
8, 15, and 22 for each
28-day cycle. Patients in
the POMALYST alone arm were
allowed to add low-dose dex
upon disease progression.
7.4-month median duration of response (n=33; 95% CI, 5.1 to 9.2)
vs NE for POMALYST + low-dose dex and POMALYST, respectively
NE, not established (the median has not yet been reached).
ORR did not differ based on type of prior anti-myeloma therapy