Adjuvant Yervoy for melanoma – pro
Ipilimumab as adjuvant therapy significantly improves overall survival in patients with high risk stage III melanoma, according to the EORTC 18071 phase III trial results presented at the ESMO 2016 Congress in Copenhagen.
The EORTC 18071 phase III trial evaluated ipilimumab as adjuvant therapy for patients with high risk stage III melanoma. During 2008 to 2011, 951 patients were randomised to ipilimumab or placebo. Interferon was not used as the comparator because in Europe it is not routinely used nor accepted as a standard of care. As reported in 2015, the study met its primary endpoint after a median follow up of 2.3 years, with ipilimumab significantly improving recurrence-free survival. The drug was subsequently approved by the US Food and Drug Administration as adjuvant therapy for stage III melanoma.
At 5.3 years median follow up, the impact on overall survival is reported and represents a 28% reduction of the relative risk of death (hazard ratio 0.72, p=0.001). There was consistency across all endpoints with hazard ratios of 0.76 for recurrence-free survival and distant metastases-free survival (p<0.001 and p=0.002). In absolute terms, the overall survival rate at five years was 11% higher in the ipilimumab arm (65%) than in the placebo arm (54%).
Alexander M M Eggermont, Vanna Chiarion-Sileni, Jean-Jacques Grob, Reinhard Dummer, Jedd D Wolchok, Henrik Schmidt, Omid Hamid, Caroline Robert, Paolo A Ascierto, Jon M Richards, Céleste Lebbé, Virginia Ferraresi, Michael Smylie, Jeff rey S Weber, Michele Maio, Cyril Konto, Axel Hoos, Veerle de Pril, Ravichandra Karra Gurunath, Gaetan de Schaetzen, Stefan Suciu, Alessandro Testori, Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial . www.thelancet.com/oncology Published online April 1, 2015 http://dx.doi.org/10.1016/S1470-2045(15)70122-1
YervoY, Precribing Information 2017