Sep 5 2013
The Lancet Oncology published this week 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<0.001). In addition a significant overall survival of 12.7 months in patients with rrMM was observed compared with 8.1 months for those treated with high-dose dexamethasone alone (p=0.028). The most common Grade 3 to 4 adverse events were neutropenia, anaemia and thrombocytopenia.1
Multiple myeloma is the second most common blood cancer2 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 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<0.001]). Median overall survival, the secondary endpoint, was also significantly improved for pomalidomide plus low-dose dexamethasone arm (12.7 months), compared with high-dose dexamethasone only (8.1 months) (due to patients still on therapy in the pomalidomide plus low-dose dexamethasone arm, the median has not yet been reached vs. 34 weeks in the high-dose dexamethasone arm [p<0.001]).1
About Celgene
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