- 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.
- 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).
- Most common were colitis, diarrhea, and fatigue.
- 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.
- Open-label trial design.