Table 2.
Efficacy outcomes according to time of data cutoff
| Data cutoff October 1, 2013 [3] | Data cutoff May 25, 2018 | |||
|---|---|---|---|---|
| BRAF inhibitor– naive cohort n = 63 |
Vemurafenib monotherapy–PD cohort n = 66 |
BRAF inhibitor- naive cohort n = 63 |
Vemurafenib monotherapy–PD cohort n = 66 |
|
| Confirmed BORR, % (95% CI) | 87.3 (76.7–94.4) | 15.2 (7.5–25.5) | 87.3 (76.7–94.4) | 15.2 (7.5–25.5) |
| Best overall response, n (%) | ||||
| Complete response | 6 (9.5) | 0 | 12 (19.0) | 1 (1.5) |
| Partial response | 49 (77.8) | 10 (15.2) | 43 (68.3) | 9 (13.6) |
| Stable disease | 6 (9.5) | 28 (42.4) | 6 (9.5) | 28 (42.4) |
| Progressive disease | 2 (3.2) | 24 (36.4) | 2 (3.2) | 24 (36.4) |
| Not assessable/not done | 0 | 4 (6.0) | 0 | 4 (6.0) |
| Duration of first confirmed objective response | ||||
| Patients who progressed or died, n (%) | 55 | 10 | 55 | 10 |
| Patients who progressed or died, n (%) | 27 (49.1)a | 5 (50.0)a | 38 (69.1)a | 7 (70.0)a |
| Median response duration, months (95% CI) | 12.5 (9.7–NE) | 6.7 (4.9–NE) | 14.3 (9.7–23.1) | 6.8 (4.9–10.4) |
| Median PFS, months (95% CI) | 13.7 (10.1–17.5) | 2.8 (2.6–3.5) | 13.8 (10.8–20.6) | 2.8 (2.6–3.4) |
| Median OS, months (95% CI) | NE (NE–NE) | 8.3 (6.0–10.9) | 31.8 (24.5–NE) | 8.5 (6.7–11.1) |
| OS rate, % (95% CI) | ||||
| 1 year | 82.8 (73.0–92.6) | 32.0 (19.4–44.6) | 82.5 (73.2–91.9) | 36.1 (24.3–47.9) |
| 2 years | — | — | 63.9 (51.8–76.1) | 18.7 (8.7–28.7) |
| 3 years | — | — | 41.5 (28.1–54.8) | 14.0 (4.7–23.4) |
| 4 years | — | — | 39.2 (25.8–52.5) | 14.0 (4.7–23.4) |
| 5 years | — | — | 39.2 (25.8–52.5) | 14.0 (4.7–23.4) |
Abbreviations: BORR, best overall response rate; NE, not evaluable; OS, overall survival; PD, progressive disease; PFS, progression-free survival.
Bold text indicates change or new data since previous analysis; — indicates data not available at the time of the previous analysis.