Table 1.
Best overall response (intention-to-treat population). Responses are based on investigator best assessment across time points per Response Evaluation Criteria in Solid Tumors v1.1 with confirmation
| Pembrolizumab + dabrafenib + trametinib n=60 n (%) |
Placebo + dabrafenib + trametinib n=60 n (%) |
Difference in rate,* % (95% CI) | |
| Objective response† | 38 (63.3) | 43 (71.7) | −8.5 (−24.8 to 8.3) |
| Complete response | 12 (20.0) | 9 (15.0) | 5.2 (−8.8 to 18.9) |
| Partial response | 26 (43.3) | 34 (56.7) | −13.8 (−30.9 to 4.3) |
| Disease control‡ | 51 (85.0) | 56 (93.3) | −8.1 (−20.1 to 3.6) |
| Stable disease | 13 (21.7) | 13 (21.7) | 0.5 (−14.6 to 15.6) |
| Progressive disease | 5 (8.3) | 3 (5.0) | 3.2 (−7.0 to 13.8) |
| Not evaluable | 2 (3.3) | 0 (0.0) | 3.4 (−2.8 to 11.6) |
| No assessment | 2 (3.3) | 1 (1.7) | 1.4 (−6.1 to 9.6) |
*Difference in rate was based on Miettinen and Nurminen method stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) and lactate dehydrogenase (LDH) (>1.1× upper limit of normal (ULN) vs ≤1.1× ULN); because of the small number of patients enrolled in the ECOG performance status 1 and LDH ≤1.1× ULN strata, these strata were combined.
†Complete response + partial response.
‡Complete response + partial response + stable disease.