KEYNOTE-006
The trial that made PD-1 blockade the first choice over the older CTLA-4 drug, with a third of patients alive at ten years.
Pembrolizumab improved PFS and OS versus ipilimumab with fewer high-grade side effects. The 10-year analysis (Annals of Oncology 2024) reported OS 34.0% versus 23.6%; patients who completed two years of pembrolizumab had durable remissions off treatment. Established anti-PD-1 monotherapy as a first-line standard and the two-year treatment duration.
Setting
Advanced melanoma, ≤1 prior systemic therapy: pembrolizumab (two schedules) vs ipilimumab
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
10-year OS 34.0% vs 23.6%.
Reported
2015
Enrolled
834
Replication
Consistent with CheckMate 066/067 (nivolumab) and long-term KEYNOTE-001 data; PD-1 superiority over ipilimumab is replicated.
In plain words
What these results mean for people, not percentages
Overall survival at 10 yearssurvival endpoint
- 34 vs 23.6 out of 100 alive at 10 years with Pembrolizumab compared with Ipilimumab; 10.4 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Advanced melanoma, ≤1 prior systemic therapy: pembrolizumab (two schedules) vs ipilimumab. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
834 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 10 years | Pembrolizumab | — | 34% | — | — | link |
| Ipilimumab | — | 23.6% |
Replication
Consistent with CheckMate 066/067 (nivolumab) and long-term KEYNOTE-001 data; PD-1 superiority over ipilimumab is replicated.