Oral
pomalidomide (Imnovid® [EU]; Pomalyst® [USA]) in combination with
dexamethasone (in the EU), is approved in several countries for the treatment of adult patients with relapsed and refractory
multiple myeloma who have received at least two prior
therapies, including
lenalidomide and
bortezomib, and have demonstrated
disease progression on the last
therapy (or progression within the last 60 days in the USA). The key therapeutic mechanisms of action of
pomalidomide, a
thalidomide analogue, reside in its immunomodulatory, antiproliferative and anti-angiogenic effects. In the pivotal, multinational phase II MM-002 and phase III MM-003 trials,
pomalidomide plus low-dose
dexamethasone was effective and had a manageable safety and tolerability profile in adult patients with relapsed and refractory
multiple myeloma who had received at least two prior antimyeloma
therapies, including at least 2 cycles of both
lenalidomide and
bortezomib. Moreover, compared with high-dose
dexamethasone, treatment with
pomalidomide plus low-dose
dexamethasone significantly prolonged progression-free survival, overall survival and time to
disease progression, and improved overall response rates in the intent-to-treat population. In general, improvements in these clinical outcomes with
pomalidomide plus low-dose
dexamethasone treatment were also observed in subgroups of patients, including those refractory to
lenalidomide,
bortezomib or both drugs, those who had received several prior antimyeloma
therapies, patients with renal impairment, elderly patients and those with a high-risk cytogenetic profile. Thus, combination
therapy with
pomalidomide plus low-dose
dexamethasone is an important emerging treatment option for use as
salvage therapy in patients with relapsed and refractory
multiple myeloma.