Long-term data support adjuvant ipilimumab for stage III melanoma

  • Eggermont AMM & al.
  • Eur J Cancer
  • 7 Aug 2019

  • curated by Brian Richardson, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Adjuvant therapy with ipilimumab is associated with improved recurrence, metastasis, and survival outcomes of patients with stage III melanoma in long-term follow-up of the European Organisation for Research and Treatment of Cancer (EORTC) 18071 trial.

Why this matters

  • This follow-up study provides evidence for sustained benefit of ipilimumab for patients with resected, stage III melanoma.

Key results

  • 7-year recurrence-free survival (RFS) was 39.2% in patients who received ipilimumab and 30.9% in patients who received placebo.
  • 7-year distant metastases-free survival (DMFS) was 44.5% in patients who received ipilimumab and 36.9% in patients who received placebo.
  • 7-year OS was 60.0% in patients who received ipilimumab and 51.3% in patients who received placebo.
  • Compared with placebo, ipilimumab was associated with longer:
    • RFS (HR, 0.75; P<.001>
    • DMFS (HR, 0.76; P=.002), and
    • OS (HR, 0.73; P=.002).
  • Benefits were similar across subgroups (men vs women, microscopic vs macroscopic involvement, ulcerated vs nonulcerated melanoma).

Study design

  • 951 patients with resected stage III cutaneous melanoma from 99 sites were randomly assigned to receive ipilimumab or placebo for up to 3 years.
  • 264 patients had recent follow-up data (6.9 years median follow-up).
  • Funding: Bristol-Myers Squibb.

Limitations

  • Many patients lost to follow-up.