Table 5.
Study group | Encorafenib plus binimetinib | Encorafenib | Vemurafenib | ||||
Overall survival | |||||||
|
Value, median (months) | 33.6 | 23.5 | 16.9 | |||
|
HRb | 0.61c | 0.76d | N/Ae | |||
Progression-free survival | |||||||
|
Value, median (months) | 14.9 | 9.6 | 7.3 | |||
|
HR | 0.51c | 0.68d | N/A | |||
Adverse events (all grade), % | 98.4 | 99.5 | 100 | ||||
Adverse events (grade ≥3), % | 68.2 | 67.7 | 65.6 | ||||
Dermatologic adverse events | |||||||
|
Rash (all grade), % | 16.1 | 20.8 | 30.1 | |||
|
Rash (grade ≥3), % | 1.6 | 2.1 | 3.2 | |||
|
Pruritus (all grade), % | 12.5 | 21.9 | 10.8 | |||
|
Pruritus (grade ≥3), % | 0.5 | 0.5 | 0 | |||
|
Hyperkeratosis (all grade), % | 15.1 | 40.1 | 29 | |||
|
Hyperkeratosis (grade ≥3), % | 0.5 | 3.6 | 0 | |||
|
Dry skin (all grade), % | 16.1 | 30.2 | 23.1 | |||
|
Dry skin (grade ≥3), % | 0 | 0.5 | 0 | |||
|
Alopecia (all grade), % | 14.6 | 56.3 | 37.6 | |||
|
Alopecia (grade ≥3), % | 0 | 0 | 0 | |||
|
Palmoplantar erythrodysesthesia syndrome (all grade), % | 7.3 | 51.6 | 14 | |||
|
Palmoplantar erythrodysesthesia syndrome (grade ≥3), % | 0 | 13.5 | 1.1 | |||
|
Photosensitivity (all grade), % | 3.6 | 3.6 | 25.3 | |||
|
Photosensitivity (grade ≥3), % | 0.5 | 0 | 1.1 | |||
|
Palmoplantar keratoderma (all grade), % | 9.9 | 26.6 | 17.7 | |||
|
Palmoplantar keratoderma (grade ≥3), % | 0 | 2.1 | 1.1 | |||
|
Keratosis pilaris (all grade), % | 4.7 | 3.6 | 25.3 | |||
|
Keratosis pilaris (grade ≥3), % | 0.5 | 0 | 1.1 | |||
|
Papillomaf (all grade), % | 7 | 10 | 19 | |||
|
Papillomaf (grade ≥3), % | N/A | N/A | N/A | |||
|
Squamous cell carcinomaf (all grade), % | 3 | 8 | 17 | |||
|
Squamous cell carcinomaf (grade ≥3), % | N/A | N/A | N/A | |||
|
Basal cell carcinomaf (all grade), % | 2 | 1 | 2 | |||
|
Basal cell carcinomaf (grade ≥3), % | N/A | N/A | N/A |
bHR: hazard ratio.
cEncorafenib plus binimetinib versus vemurafenib.
dEncorafenib versus vemurafenib.
eN/A: not applicable.
fThese dermatologic adverse events were reported separately by Gogas et al [20] as all grade dermatologic adverse events with no further breakdown.