Disposition of patients with BRAF V600–mutant LCH
| Status, n (%) . | CDRB436A2102 (dabrafenib monotherapy) . | CTMT212X2101 (dabrafenib + trametinib) . | ||||
|---|---|---|---|---|---|---|
| Escalation part (n = 2) . | Expansion part (n = 11) . | All LCH (n = 13) . | Escalation part (n = 2) . | Expansion part (n = 10) . | All LCH (n = 12) . | |
| Ongoing | 0 | 0 | 0 | 0 | 0 | 0 |
| Entered rollover study | 0 | 7 (63.6) | 7 (53.8) | 0 | 8 (80.0) | 8 (66.7) |
| Withdrawn from study | 2 (100) | 4 (36.4) | 6 (46.2) | 2 (100) | 2 (20.0) | 4 (33.3) |
| Lack of efficacy | 0 | 0 | 0 | 0 | 1 (10.0) | 1 (8.3) |
| AE | 1 (50.0) | 1 (9.1) | 2 (15.4) | 1 (50.0) | 1 (10.0) | 2 (16.7) |
| Investigator discretion | 1 (50.0) | 1 (9.1) | 2 (15.4) | 0 | 0 | 0 |
| Other | 0 | 2 (18.2) | 2 (18.2) | 1 (50.0) | 0 | 1 (8.3) |
| Status, n (%) . | CDRB436A2102 (dabrafenib monotherapy) . | CTMT212X2101 (dabrafenib + trametinib) . | ||||
|---|---|---|---|---|---|---|
| Escalation part (n = 2) . | Expansion part (n = 11) . | All LCH (n = 13) . | Escalation part (n = 2) . | Expansion part (n = 10) . | All LCH (n = 12) . | |
| Ongoing | 0 | 0 | 0 | 0 | 0 | 0 |
| Entered rollover study | 0 | 7 (63.6) | 7 (53.8) | 0 | 8 (80.0) | 8 (66.7) |
| Withdrawn from study | 2 (100) | 4 (36.4) | 6 (46.2) | 2 (100) | 2 (20.0) | 4 (33.3) |
| Lack of efficacy | 0 | 0 | 0 | 0 | 1 (10.0) | 1 (8.3) |
| AE | 1 (50.0) | 1 (9.1) | 2 (15.4) | 1 (50.0) | 1 (10.0) | 2 (16.7) |
| Investigator discretion | 1 (50.0) | 1 (9.1) | 2 (15.4) | 0 | 0 | 0 |
| Other | 0 | 2 (18.2) | 2 (18.2) | 1 (50.0) | 0 | 1 (8.3) |