Pomalidomide is an immunomodulator that inhibits proliferation and induces apoptosis of haematopoietic tumour cells. In addition, it has been shown to enhance T cell- and natural killer cell-mediated immunity and to inhibit production of pro-inflammatory cytokines.1,2
In a phase III, open-label study, 455 patients with relapsed and/or refractory myeloma were randomised to receive pomalidomide plus low-dose dexamethasone (n=302) or high-dose dexamethasone alone (n=153).1,2
Patients received either pomalidomide 4mg daily on days 1–21 of each 28-day treatment cycle plus oral dexamethasone 40mg once daily on days 1, 8, 15 and 22 or monotherapy with dexamethasone 40mg once daily on days 1–4, 9–12 and 17–20. Treatment was continued until disease progression or unacceptable toxicity.1,2
Median progression-free survival (the primary efficacy endpoint) was improved by 4 months (95% CI 3.6–4.7) in the pomalidomide plus dexamethasone group compared with 1.9 months in the dexamethasone-only group (HR 0.48, 95% CI 0.39–0.60; p<0.0001).2
The most commonly reported adverse effects were anaemia, neutropenia and thrombocytopenia.1,2
Pomalidomide is structurally related to thalidomide and is therefore expected to be teratogenic. To prevent exposure of pregnant women to pomalidomide, healthcare professionals and patients are required to adhere to the measures specified in the Pregnancy Prevention Programme.1
- Imnovid Summary of Product Characteristics, August 2013.
- Miguel J et al. Lancet Oncol 2013; 14: 1055–66.
Further information: Celgene Ltd