Table 3.
Response by investigator assessment (response-evaluable population)
| Dose escalation phase | Dose expansion phase: molecularly defined cohorts | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Q2D n = 22 |
QW n = 14 |
BRAF+ Naïve Q2D n = 16 Cohort 1 |
BRAF+ Previously treated Q2D n = 6 Cohort 2 |
NRAS+ Naïve Q2D n = 14 Cohort 3 |
NRAS + Previously treated Q2D n = 1 Cohort 4 |
BRAF/NRAS WT Naïve Q2D n = 6 Cohort 5 |
BRAF/NRAS
WT Previously Q2D n = 9 Cohort 6 |
NRAS+ Naïve QW n = 17 Cohort 9 |
|
| Objective response rate | 0 | 2 (14) | 8 (50) | 1 (17) | 1 (7) | 0 | 0 | 0 | 0 |
| 95% CI | – | 2–43 | 25–75 | < 1–64 | < 1–34 | – | – | – | – |
| Best overall response | |||||||||
| Complete response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Partial response | 0 | 2 (14) | 8 (50) | 1 (17) | 1 (7) | 0 | 0 | 0 | 0 |
| Stable disease | 5 (23) | 4 (29) | 2 (13) | 3 (50) | 4 (29) | 0 | 1 (17) | 3 (33) | 9 (53) |
| Progressive disease | 17 (77) | 8 (57) | 6 (38) | 2 (33) | 9 (64) | 1 (100) | 5 (83) | 6 (67) | 8 (47) |
Data are n (%), unless otherwise stated
BRAF+ BRAF mutation-positive, DLT dose-limiting toxicity, NRAS+ NRAS mutation-positive, Q2D once every other day, QW once weekly, WT wild-type