Authors' objectives: This report is based on the analysis of the EORTC 18071 trial, a randomised double-blind phase III trial, which was conducted to assess the efficacy of adjuvant therapy with ipilimumab on all survival endpoints of patients with high-risk stage III cutaneous melanoma after complete regional lymph node dissection.

Authors' recommendations: At a median follow-up of 5.3 years, the primary endpoint; recurrence-free survival rate at five years (+10.5%), as well as the secondary endpoints; overall survival rate (+11.0%) and rate of distant metastasis-free survival at five years (+9.4%) were significantly improved in the ipilimumab group compared to the placebo group. However, no data on median OS and median progression-free survival were available at the time of data cut-off. In terms of safety, there was a 40.0% difference in grade ≥3 immune-related adverse events in the ipilimumab group, and five patients (1.1%) died due to immune-related adverse events, before the start of the maintenance therapy. In total, 240 of 471 patients (51.0%) discontinued treatment due to an ipilimumab-induced adverse event. Moreover, no clinically relevant differences in global health status scores were observed during or after induction therapy between the two treatment groups. Overall, even though the administration of ipilimumab increases the rate of toxicities, no statistically significant differences in health-related quality of life scores between the treatment groups have been observed. The identification of predictive biomarkers may be crucial in order to further improve response rates and outcomes, and to reduce severe adverse events. In addition, ongoing studies remain to be seen in order to gain comparable results. Finally, aiming for a reduction of immune therapy costs (annual ipilimumab therapy costs: € 435,850.10) may be a crucial step in the near future.

Project Status: Completed

URL for project: http://hta.lbg.ac.at/page/horizon-scanning-in-der-onkologie/en

Year Published: 2017

URL for published report: http://eprints.hta.lbg.ac.at/1119/1/DSD_HSO_Nr.67.pdf

URL for additional information: http://eprints.hta.lbg.ac.at/1119/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Austria

Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment

Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99

Contact Name: tarquin.mittermayr@aihta.at

Contact Email: office@aihta.at

Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)