Advanced melanoma: pembrolizumab superior to ipilimumab in 5-year follow-up

  • Lancet Oncol

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

  • 5-year follow-up of the open-label, phase 3 KEYNOTE-006 trial concludes that pembrolizumab is associated with superior survival outcomes compared with ipilimumab in patients with advanced melanoma.

Why this matters

  • Results provide further support for the use of pembrolizumab in this patient group.

Key results

  • Pembrolizumab was associated with improved median OS (32.7 vs 15.9 months; HR, 0.73; P=.00049) and PFS (8.4 vs 3.4 months; HR, 0.57; P<.0001 compared with ipilimumab. style="list-style-type:circle;">
  • In subgroup analysis, pembrolizumab was associated with improved median OS in patients who received pembrolizumab vs ipilimumab as first-line treatment (HR, 0.73; P=.0036) or second-line treatment (HR, 0.75; P=.036).
  • 17% of patients treated with pembrolizumab and 20% of patients treated with ipilimumab experienced grade 3/4 treatment-related adverse events.
    • Most common were colitis, diarrhea, and fatigue.
  • 1 patient who received pembrolizumab died from treatment-related sepsis.
  • Study design

    • 834 patients with advanced melanoma (unresectable stage III/IV) were randomly assigned to receive pembrolizumab (n=556) or ipilimumab (n=278), with a median follow-up of 57.7 months in surviving patients.
    • Funding: MSD.

    Limitations

    • Open-label trial design.