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Medline ® Abstract for Reference 20

of 'Immunotherapy of advanced melanoma with immune checkpoint inhibition'

Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial.
Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD
J Clin Oncol. 2015;33(10):1191. Epub 2015 Feb 23.
PURPOSE: There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival. To demonstrate a long-term survival benefit with ipilimumab, we evaluated the 5-year survival rates of patients treated in a randomized, controlled phase III trial.
PATIENTS AND METHODS: A milestone survival analysis was conducted to capture the 5-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial. Patients were randomly assigned 1:1 to receive ipilimumab at 10 mg/kg plus dacarbazine (n = 250) or placebo plus dacarbazine (n = 252) at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22. Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24. A safety analysis was conducted on patients who survived at least 5 years and continued to receive ipilimumab as maintenance therapy.
RESULTS: The 5-year survival rate was 18.2% (95% CI, 13.6% to 23.4%) for patients treated with ipilimumab plus dacarbazine versus 8.8% (95% CI, 5.7% to 12.8%) for patients treated with placebo plus dacarbazine (P = .002). A plateau in the survival curve began at approximately 3 years. In patients who survived at least 5 years and continued to receive ipilimumab, grade 3 or 4 immune-related adverse events were observed exclusively in the skin.
CONCLUSION: The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine. These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma.
Michele Maio, University Hospital of Siena, Siena; Vanna Chiarion-Sileni, Veneto Oncology Institute-Istituto Di Ricovero e Cura a Carattere Scientifico, Padova; Alessandro Testori, Istituto Europeo di Oncologia, Milan, Italy; Jean-Jacques Grob, Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille, Hôpital Timone, Marseille; Luc Thomas, Lyon 1 University, Centre Hospitalier Lyon Sud, Pierre Bénite; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Steinar Aamdal, Oslo University Hospital and Radium Hospital, Oslo, Norway; Igor Bondarenko, Dnepropetrovsk State Medical Academy, Dnepropetrovsk, Ukraine; Claus Garbe, University Medical Center, Tübingen, Germany; Tai-Tsang Chen and Marina Tschaika, Bristol-Myers Squibb, Wallingford, CT; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY. mmaiocro@gmail.com.