Table 1 Systemic melanoma therapies: Phase III clinical trial outcomes
From: Liquid biomarkers in melanoma: detection and discovery
Therapy | ORR | Median PFS (months); % survival (year) | Median OS (months); % survival (year) | Grade 3/4 toxicity | Biomarkers examined | Reference |
|---|---|---|---|---|---|---|
Molecular therapies | ||||||
Vemurafenib1 (n = 337) | 48% | 6.9; 14% (1.5 years) | 13.6; 39% (1.5 years) | 73% | BRAF V600 mutation and LDH [131] | |
Dabrafenib1 (n = 187) | 50% | 5.1; 12% (3 years) | 20; 45% (2 years) | 53%¥ | BRAF V600 mutation and LDH [134] | |
Trametinib2 (n = 214) | 22% | 4.8; NR | NR; 81% (6 months) | NR | BRAF V600 mutation and LDH [137] | [138] |
Dabrafenib + trametinib (n = 352) | 64% | 12.1; 30% (2 years), 24% (3 years) | 25.6; 73% (1 year), 52% (2 years), 44% (3 years) | 52% | BRAF V600 mutation and LDH [139] | |
Vemurafenib + cobimetinib2(n = 247) | 70% | 12.3; NR | 22.3; 75% (1 year), 48% (2 years) | 60% | Ki67, p56, MAPK, PI3K pathways, cell proliferation, CD8 T cells [141] | [141] |
Immunotherapies | ||||||
gp1003 (n = 136)* | 1.5% | 2.8; 48.5% (12 weeks) | 6.4; 25.3% (1 year), 13.7% (2 years) | 11.4% | LDH [3] | [3] |
Ipilimumab4 (n = 278) | 13% | 2.8; 14% (2 years) | 16.0; 43% (2 years) | 20% | LDH, peripheral blood absolute lymphocyte count [142] | |
gp100 + ipilimumab (n = 403)* | 5.7% | 2.8; 49.1% (12 weeks) | 10; 44% (1 year), 21.6% (2 years) | 17.4% | LDH [3] | [3] |
Nivolumab5 (n = 210) | 40% | 5.1; 44% (1 year) | Not reached; 73% (1 year) | 11.7% | Tumor cell PD-L1 expression, peripheral blood absolute lymphocyte count [142] | [144] |
Pembrolizumab5 (n = 277) | 36% | 4.1; 28% (2 years) | Not reached; 55% (2 years) | 17% | LDH, blood count parameters [129] | |
Ipilimumab + nivolumab (n = 314) | 57.6% | 11.5; 49% (1 year), 39% (3 years) | Not reached; 64% (2 years), 58% (3 years) | 55% | Tumor cell PD-L1 expression, peripheral blood absolute lymphocyte count [142] | |
T-VEC6 (n = 295) | 26.4%** | NR | 23.3; 50% (2 years) | 36% | None | [146] |