According to a study published online last week in the Journal of Clinical Oncology, ipilimumab plus dacarbazine provide a durable survival benefit at 5 years in patients treated for advanced melanoma.
Previous nonrandomized studies have shown that a proportion of ipilumumab-treated patients with advanced melanoma experience long-term survival, but researchers sought to investigate that benefit in a randomized, controlled phase III trial.
For the study, researchers enrolled 502 treatment-naive patients with advanced melanoma and randomly assigned them 1:1 to receive ipilimumab 10mg/kg plus dacarbazine or placebo plus dacarbazine at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22.
Eligible patients could then receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24.
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Results showed that the 5-year survival rate for patients treated with ipilimumab plus dacarbazine was 18.2% (95% CI: 13.6 – 23.4) compared with 8.8% (95% CI: 5.7 – 12.8) for patients treated with placebo plus dacarbazine (P = 0.002).
Researchers observed a plateau in survival beginning at approximately 3 years. In regard to safety, among those who survived at least 5 years and continued to receive treatment with ipilimumab, grade 3 or 4 immune-related adverse events were only observed in the skin.