Pivotal study supports use of IMNOVID® - (pomalidomide) in patients with relapsed or refractory multiple myeloma

Date: Sep-09-2013The Lancet Oncology has published findings from a study, which showed that the new oral therapy IMNOVID® - (pomalidomide), used in combination with low-dose dexamethasone demonstrated a significant survival advantage over high-dose dexamethasone alone, in patients with relapsed and refractory multiple myeloma (rrMM).[1]

"Unfortunately the prognosis for relapsed and refractory multiple myeloma is poor as there are few effective therapeutic options for people living with this disease" said Professor Steve Schey, Kings College London, author and UK Principal Investigator of the study. "While remission is generally achieved after initial treatment, in the majority of cases the cancer returns and these patients relapse, requiring further treatment. The results of this study have shown that there is a new and effective treatment available for patients who have failed all existing options."

The study, known as MM-003, is a Phase III, multi-centre, randomised, open-label study, which involved 455 patients from 16 countries, including the UK, between March 2011 and September 2012. The study was designed to compare the efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in patients with rrMM. The results demonstrated significantly improved median progression-free survival, the primary end point, of 4 months for patients who were treated with pomalidomide plus low-dose dexamethasone compared with 1.9 months for those treated with high-dose dexamethasone only (p

Multiple myeloma is the second most common blood cancer[2] and affects an estimated 9,900 people in the UK and Ireland.[3] The disease causes plasma cells to replicate uncontrollably and accumulate in the bone marrow, disrupting the production of normal blood cells. Nearly all individuals diagnosed with multiple myeloma will eventually relapse and require treatment with an alternative therapy.[4] For this reason, it is crucial that new and effective options continue to be made available to them to enable continued disease control.[5]

Pomalidomide was granted Marketing Authorisation by the European Medicines Agency in August 2013 and is now available in the UK and Ireland.
About pomalidomide

Pomalidomide is an oral immunomodulatory drug (IMiD®) with a multi-modal mechanism of action consisting of three main effects demonstrated in vitro: direct antimyeloma, stromal inhibitory effects and immunomodulatory effects. Pomalidomide in combination with dexamethasone has been approved for adult patients who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.[6]

The recommended starting dose of pomalidomide is 4 mg once daily, orally on days 1-21 of repeated 28-day cycles until disease progression. Pomalidomide should be given with low-dose dexamethasone.

About the MM-003 study
The MM-003 study is a Phase III, multi-centre, randomised (2:1), open-label study in 455 patients across 16 countries including the UK, Australia and Canada. The trial evaluated use of oral pomalidomide plus low-dose dexamethasone (n=302) compared with high-dose dexamethasone (n=153) in patients with rrMM. According to the protocol, all patients were to have been treated with both bortezomib and lenalidomide prior to study entry. In the trial, progression-free survival, the primary endpoint, was significantly longer in patients who received pomalidomide plus low-dose dexamethasone (4.0 months) compared with those who received high-dose dexamethasone alone (1.9 months [p

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