Ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody, was initially approved by the U.S. Food and Drug Administration in 2011 for the treatment of patients with unresectable or metastatic melanoma at dose of 3 mg/kg every 3 weeks for a total of four doses.2

The authors acknowledge the dose difference and note that the ongoing ECOG 1609 trial that is comparing high-dose interferon with 1 year of ipilimumab treatment at either 3 mg/kg or 10 mg/kg might determine if either dose improves outcomes while causing less toxicity compared with high-dose interferon.1


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The safety profile observed in this study was consistent with previous studies of ipilimumab that showed the most common adverse reactions to be fatigue, diarrhea, pruritus, rash, and colitis, all of which occured in more than 5% of patients.1,2

However, in this study, 1% of patients died as a result of ipilimumab-related adverse events and 52% of patients who started ipilimumab experienced adverse events that led to discontinuation of treatment.1

RELATED: Higher C-Reactive Protein Predicts Worse Survival in Melanoma

A previous study in patients with metastatic melanoma showed that the addition of ipilimumab to an investigational peptide vaccine improved median overall survival by nearly 4 months compared with the vaccine alone, but distant metastasis-free survival and overall survival endpoints need to be assessed in this patient population before the definitive value of adjuvant ipilimumab at this dose and schedule can be determined.1,3

Despite the yet to be determined risk–benefit ratio of adjuvant ipilimumab, the findings suggest that ipilimumab at this dose and schedule “represents an option in the current adjuvant landscape for those who have experience when administering the drug.”1

Overall survival data for this study is not yet mature and will be reported in the future.1

References

  1. Eggermont AMM, Charion-Sileni V, Grob J-J, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC  18071): a randomized, double-blind, phase 3 trial. Lancet Oncol. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70122-1.
  2. YERVOY (ipilimumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb. http://packageinserts.bms.com/pi/pi_yervoy.pdf.
  3. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723.