Wednesday, 12 October 2016

Ipilimumab 10 mg/kg vs placebo in adjuvant setting

One of the highlights of #ESMO2016 in melanoma:

A. Eggermont reported the efficacy of adjuvant therapy with ipilimumab in patients with high-risk stage III melanoma after complete lymph-node dissection at a median follow-up of 5.3 years.

Ipi 10 mg/kg showed benefit in overall survival over ipi 3 mg/kg. At a minimum follow-up of ~43 months, median OS (primary endpoint) was 15.7 months with 10 mg/kg versus 11.5 months with ipi 3 mg/kg.

At 5 years, ipilimumab had rates that were approximately 10 %  higher than the rates with placebo: recurrence-free survival (40.8% vs. 30.3%),
overall survival (65.4% vs. 54.4%), and
distant metastasis–free survival (48.3% vs. 38.9%).

However increased toxicity was noticed.  Grade 3 or 4 adverse events occurring in 54.1%. Five patients died due to adverse events of ipilimumab. The results were also published in NEJM on 6 October 2016.

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