Imnovid: immunomodulator for multiple myeloma

1 November 2013

Imnovid (pomalidomide) is indicated in combination with dexamethasone for relapsed and refractory multiple myeloma that has progressed in patients who have received at least two prior therapies, including lenalidomide and bortezomib.

Imnovid is given as 4mg once daily on days 1—21 of repeated 28-day cycles, with the dose adjusted according to response

PHARMACOLOGY

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

CLINICAL STUDIES

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

Greater survival

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

Teratogenic risk

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

References:

View Imnovid drug record

Further information: Celgene Ltd