Table 1.
Melanoma clinical trials with long-term survival results.
| Trial | Treatment arms | Median follow-up | Median PFS/recurrence-free survival/intracranial PFS (95% CI) | Median OS/distant metastasis-free survival (95% CI) |
|---|---|---|---|---|
| KEYNOTE-001 (33) | Pembrolizumab monotherapy | 55 months | Median PFS was 8.3 months (95% CI: 5.8–11.1) in all patients and 16.9 months (95% CI: 9.3–35.5) in treatment-naive patients | Median OS was 23.8 months (95% CI: 20.2–30.4) in all patients and 38.6 months (95% CI: 27.2–not reached) in treatment-naive patients |
| (NCT01295827) | Total melanoma patients (n = 655); treatment naive (n = 151) or previously untreated (n = 496) | 5-year PFS rates were 21% in all patients, 29% in treatment-naive patients | 5-year OS rates: 34% in all patients, 41% in treatment-naive patients | |
| KEYNOTE-006 (34) | Pembrolizumab monotherapy or ipilimumab monotherapy | 57.7 months | Median PFS was 8.4 months (95% CI: 6.6–11.3) in the combined pembrolizumab groups versus 3.4 months (95% CI: 2.9–4.2) in the ipilimumab group (HR 0.57, 95% CI: 0.48–0.67, p < 0.0001) | Median OS was 32.7 months (95% CI: 24.5–41.6) in the combined pembrolizumab groups and 15.9 months (95% CI: 13.3–22.0) in the ipilimumab group (HR 0.73, 95% CI: 0.61–0.88, p = 0.00049) |
| (NCT01866319) | Total (n = 834); pembrolizumab 10 mg/kg every 2 weeks (n = 279), 10 mg/kg every 3 weeks (n = 277), or ipilimumab 3 mg/kg every 3 weeks (n = 278) | |||
| KEYNOTE-587 (35) | Pembrolizumab monotherapy or ipilimumab monotherapy | 7-year follow-up data | Not reported | Median OS was 32.7 months for pembrolizumab-treated patients versus 15.9 months for ipilimumab-treated patients (HR 0.70, 95% CI: 0.58–0.83) |
| (NCT03486873) | Extended follow-up after conclusion of KEYNOTE-006 (n = 210); pembrolizumab (n = 158) or ipilimumab (n = 52) | 7-year OS rates: 37.8% for pembrolizumab and 25.3% for ipilimumab | ||
| CheckMate 067 (1) | Nivo + ipi or nivolumab monotherapy or ipilimumab monotherapy | Minimum follow-up of 6.5 years | Median PFS: 11.5 months (95% CI: 8.7–19.3) nivo + ipi, 6.9 months (5.1–10.2) nivolumab, 2.9 months (2.8–3.2) ipilimumab | Median OS: 72.1 months (38.2–NR) nivo + ipi, 36.9 months (28.2–NR) nivo, and 19.9 months (16.8–24.6) ipi |
| (NCT01844505) | Nivo + ipi (n = 314), nivolumab only (n = 316), or ipilimumab only (n = 315) | 6.5-year PFS rates: 34% (95% CI: 29%–40%) nivo + ipi, 29% (95% CI: 23%–34%) nivolumab, 7% (95% CI: 4%–11%) ipilimumab | 6.5-year OS rates: 49% (95% CI: 44%–55%) nivo + ipi, 42% (95% CI: 37%–42%) nivolumab, 23% (95% CI: 19%–28%) ipilimumab | |
| CheckMate 238 (36) | Adjuvant nivolumab monotherapy or ipilimumab monotherapy | 51.1 months in adjuvant nivolumab | 4-year recurrence-free survival was 51.7% (95% CI: 46.8–56.3) in the nivolumab group and 41.2% (36.4–45.9) in the ipilimumab group (p = 0.0003) | 4-year OS was 77.9% in the nivolumab-only group and 76.6% in the ipilimumab-only group (p = 0.31) |
| (NCT02388906) | Total (n = 453); adjuvant nivolumab only (n = 453) or adjuvant ipilimumab only (n = 453) | 50.9 months in adjuvant ipilimumab | ||
| KEYNOTE-054 (37) | Adjuvant pembrolizumab monotherapy or placebo | 42.3 months | 3.5-year recurrence-free survival was 59.8% (95% CI: 55.3%–64.1%) in the pembrolizumab group and 41.4% (95% CI: 37.0%–45.8%) in the placebo group (HR 0.59, 95% CI: 0.49–0.70) | 3.5-year distant metastasis-free survival was 65.3% (95% CI: 60.9%–69.5%) in the pembrolizumab group and 49.4% (95% CI: 44.8%–53.8%) in the placebo group (HR 0.60, 95% CI: 0.49–0.73, p < 0.0001) |
| (NCT02362594) | Total (n = 1,019); adjuvant pembrolizumab (n = 514) or adjuvant placebo (n = 505) | |||
| CheckMate 204 (93) | Nivo + ipi with active melanoma brain metastases | 34 months | 36-month intracranial PFS rate (icPFS): 54% (95% CI: 43%–64%) cohort A, icPFS 19% (95% CI: 5%–40%) cohort B | OS rate 72% (95% CI: 43%–64%) cohort A, 37% (95% CI: 14%–60%) cohort B |
| (NCT02320058) | Total (n = 119); cohort A: asymptomatic (n = 101) or cohort B: symptomatic and/or steroid requiring (n = 18) | |||
| ABC trial (91) | Nivo + ipi or nivolumab monotherapy with active melanoma brain metastases (mets) | 54 months | 5-year icPFS: 46% cohort A, 15% cohort B, 6% cohort C | 5-year OS rates: 51% cohort A, 34% cohort B, 13% cohort C |
| (NCT02374242) | Total (n = 76); asymptomatic brain mets with no prior local brain therapy | |||
| Cohort A: nivo + ipi (n = 35), cohort B: nivolumab only (n = 25), or cohort C: brain mets, previous local therapy with neuro symptoms and/or with leptomeningeal disease, nivolumab only (n = 16) |