Ipilimumab improves melanoma survival in trials
A suggests the human monoclonal antibody ipilimumab, in combination with dacarbazine, improves overall survival in patients with previously untreated metastatic melanoma.
Results from the randomised, double-blind trial, funded by manufacturer Bristol-Myers Squibb, were presented at this year’s American Society of Clinical Oncology meeting and published online in the New England Journal of Medicine (5 June 2011).The study included 502 patients with previously untreated metastatic melanoma who were randomly assigned to receive dacarbazine (850mg/m2) and either ipilimumab (10mg/kg) or placebo.
Overall survival was longer in the ipilimumab group than the placebo group (11.2 months versus 9.1 months). In the ipilimumab group, an estimated 28.5 per cent of patients were alive at two years and 20.8 per cent at three years compared with 17.9 per cent and 12.2 per cent in the placebo group (hazard ratio for death 0.72; P<0.001).
Severe adverse events occurred in 56.3 per cent of patients treated with ipilimumab compared with 27.5 per cent in the placebo group (P<0.001).
Liver function affected
Rates of gastrointestinal events were lower than expected based on previous studies and there were no gastrointestinal perforations. However, the rates of serious hepatic adverse events were higher than in previous studies.
There were elevated alanine aminotransferase levels in 33 per cent of the ipilimumab group compared with 5.6 per cent in the placebo group and an increase in aspartate aminotransferase levels in 29 per cent of the ipilimumab group compared with 5.6 per cent of the placebo group.
Ipilimumab works by blocking the activity of cytotoxic T-lymphocyte antigen-4, which is thought to play a role in switching off the body’s immune response. By blocking this activity, the drug increases the number and production of active T cells that can target and destroy a tumour.
A previous phase III study found that ipilimumab monotherapy at a dose of 3mg/kg improved survival in patients with previously treated metastatic melanoma.
Last month (19 May 2011), the European Medicines Agency recommended the granting of a marketing authorisation for ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. Its advice has gone to the European Commission, which is due to give a decision by August 2011.
Citation: Electronicjuice URI: 11079554
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