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) |
ECOG PS Eastern Cooperative Oncology Group performance status, LDH lactate dehydrogenase, PD progressive disease, ppOS postprogression overall survival, RPA recursive partitioning analysis, SLD sum of longest diameters, ULN upper limit of normal