Table 1 Demographic and clinical characteristics for patients included in the RPA
Characteristic | All pooled patients N = 1004 | Cobimetinib + vemurafenib n = 184 | Vemurafenib monotherapy n = 555 | Dacarbazine n = 265 |
|---|---|---|---|---|
Age, n (%) | (n = 1004) | (n = 184) | (n = 555) | (n = 265) |
< 65 y | 758 (75.5) | 142 (77.2) | 405 (73.0) | 211 (79.6) |
≥ 65 y | 246 (24.5) | 42 (22.8) | 150 (27.0) | 54 (20.4) |
Sex, n (%) | (n = 1004) | (n = 184) | (n = 555) | (n = 265) |
Male | 600 (59.8) | 117 (63.6) | 335 (60.4) | 148 (55.8) |
Female | 404 (40.2) | 67 (36.4) | 220 (39.6) | 117 (44.2) |
Race, n (%) | (n = 1004) | (n = 184) | (n = 555) | (n = 265) |
White | 971 (96.7) | 167 (90.8) | 539 (97.1) | 265 (100.0) |
Nonwhite | 33 (3.3) | 17 (9.2) | 16 (2.9) | 0 |
Region, n (%) | (n = 1004) | (n = 184) | (n = 555) | (n = 265) |
North America | 270 (26.9) | 47 (25.5) | 163 (29.4) | 60 (22.6) |
Europe | 590 (58.8) | 108 (58.7) | 314 (56.6) | 168 (63.4) |
Australia/New Zealand/Others | 144 (14.3) | 29 (15.8) | 78 (14.1) | 37 (14.0) |
Baseline disease stage, n (%) | (n = 1004) | (n = 184) | (n = 555) | (n = 265) |
Unresectable IIIC, M1a, or M1b | 332 (33.1) | 57 (31.0) | 184 (33.2) | 91 (34.3) |
M1c | 672 (66.9) | 127 (69.0) | 371 (66.8) | 174 (65.7) |
Baseline ECOG PS, n (%) | (n = 1001) | (n = 182) | (n = 554) | (n = 265) |
0 | 651 (65.0) | 129 (70.9) | 343 (61.9) | 179 (67.5) |
1 | 350 (35.0) | 53 (29.1) | 211 (38.1) | 86 (32.5) |
Baseline LDH, n (%) | (n = 942) | (n = 173) | (n = 523) | (n = 246) |
Normal | 495 (52.5) | 82 (47.4) | 276 (52.8) | 137 (55.7) |
Elevated ≤ 2 × ULN | 290 (30.8) | 61 (35.3) | 154 (29.4) | 75 (30.5) |
Elevated > 2 × ULN | 157 (16.7) | 30 (17.3) | 93 (17.8) | 34 (13.8) |
Baseline liver metastasis, n (%) | (n = 1001) | (n = 184) | (n = 552) | (n = 265) |
Yes | 375 (35.7) | 69 (37.5) | 199 (36.1) | 89 (33.6) |
No | 644 (64.3) | 115 (62.5) | 353 (63.9) | 176 (66.4) |
ECOG PS at PD, n (%) | (n = 926) | (n = 166) | (n = 519) | (n = 241) |
0 | 489 (52.8) | 108 (65.1) | 266 (51.3) | 115 (47.7) |
1 | 356 (38.4) | 50 (30.1) | 209 (40.3) | 97 (40.2) |
2 | 55 (5.9) | 4 (2.4) | 29 (5.6) | 22 (9.1) |
3 | 22 (2.4) | 4 (2.4) | 13 (2.5) | 5 (2.1) |
4 | 4 (0.4) | 0 | 2 (0.4) | 2 (0.8) |
Postprogression treatment, n (%) | (n = 1004) | (n = 184) | (n = 555) | (n = 265) |
Immunotherapy | 202 (20.1) | 39 (21.2) | 114 (20.5) | 49 (18.5) |
Targeted therapy | 58 (5.8) | 14 (7.6) | 27 (4.9) | 17 (6.4) |
Other | 744 (74.1) | 131 (71.2) | 414 (74.6) | 199 (75.1) |
Baseline SLD, mm | (n = 995) | (n = 184) | (n = 546) | (n = 265) |
Mean (SD) | 87.1 (75.2) | 86.2 (63.7) | 91.2 (85.6) | 79.3 (57.2) |
Median (range) | 70.0 (9–1310) | 72.0 (10–398) | 71.5 (9–1310) | 66.0 (9–295) |