Table 1.
Summary of outcomes of Phase III trials of trametinib in monotherapy and in combination with dabrafenib for the treatment of BRAF V600-mutated melanoma
| METRIC24
|
COMBI-d25,37
|
COMBI-v26
|
||||
|---|---|---|---|---|---|---|
| Trametinib n=214 | Chemotherapy n=108 | Dabrafenib + trametinib n=210 | Dabrafenib n=210 | Dabrafenib + trametinib n=351 | Vemurafenib n=350 | |
| CR, n (%) | 4 (2) | 0 | 22 (10) | 18 (9) | 47 (13) | 27 (8) |
| PR, n (%) | 43 (20) | 9 (8) | 118 (56) | 90 (43) | 179 (51) | 153 (44) |
| SD | 119 (56) | 34 (31) | 54 (26) | 59 (33) | 92 (26) | 106 (30) |
| RR, n (%) | 22 (16.6–28.1) | 8 (3.9–15.2) | 67 | 51 | 226 (64) (59.1–69.4) | 180 (51) (46.1–56.2) |
| P-value | <0.001 | <0.001 | <0.001 | |||
| Median duration of response, months | NR | 5.5 | 10.2 | 9.2 | 13.8 (11–NR) | 7.5 (7.3–9.3) |
| Median PFS 95% CI | 4.8 (4.3–4.9) | 1.5 (1.4–2.7) | 9.3 | 8.8 | 11.4 (9.9–14.9) | 7.3 (5.8–7.8) |
| HR (95% CI) | 0.45 (95% CI 0.33–0.63) | 0.75 (95% CI 0.57–0.99) | 0.56 (0.46–0.69) | |||
| P-value | <0.001 | 0.035 | <0.001 | |||
| OS rate (at 6 months) (%) | 81 | 67 | 93 | 85 | 72 | 65 |
| HR (95% CI) | 0.54 (95% CI 0.32–0.92) | 0.63 (95% CI 0.42–0.94) | 0.69 (95% CI 0.53–0.89) | |||
| P-value | 0.01 | 0.023 | 0.005 | |||
| Median OS, months (95% CI) | 15.6 (14.0–17.4) | 11.3 (7.2–14.8) | 25.1 | 18.7 | NR | 17.2 |
Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PFS, progression-free survival; OS, overall survival; HR, hazard ratio; NR, not reported; RR, response rate; CI, confidence interval.