B-Raf enzyme inhibitors

Description Results NMA

PFS 0.54 [0.41; 0.71]

oral encorafenib 450 mg once daily plus oral binimetinib 45 mg twice daily (n=192)

vs.

oral vemurafenib 960 mg twice daily (n=191)

3 arms: oral encorafenib 450 mg once daily plus oral binimetinib 45 mg twice daily (encorafenib plus binimetinib group), oral encorafenib 300 mg once daily (encorafenib group), or oral vemurafenib 960 mg twice daily (vemurafenib group)

open label

Sample size: 192/191

Primary endpoint: Progression free survival

FU duration: 16.6 mo (median)

PFS 0.39 [0.25; 0.61] median 9.4 mo vs. 5.8 mo

dabrafenib (150 mg) plus trametinib (1 or 2 mg) (n=162)

vs.

dabrafenib monotherapy (n=-9)

Sample size: 162/-9

Primary endpoint:

FU duration:

phase 2

OS 0.69 [0.53; 0.89]

PFS 0.56 [0.46; 0.69] median 11.4 mo vs. 7.3 mo

(n=-9)

vs.

(n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

OS 0.63 [0.42; 0.94]

PFS 0.75 [0.57; 0.99]

dabrafenib and trametinib (n=423)

vs.

dabrafenib monotherapy (n=0)

Sample size: 423/0

Primary endpoint: Progression-Free Survival

FU duration:

OS 0.57 [0.42; 0.78]

PFS 0.47 [0.39; 0.57]

distant metastasis free survival 0.51 [0.40; 0.65]

dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months (n=-9)

vs.

placebo (n=-9)

double-blind

Sample size: -9/-9

Primary endpoint: Relapse-free survival

FU duration:

(n=-9)

vs.

(n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

PFS 0.65 [0.50; 0.85]

OS 0.72 [0.49; 1.08]

e twice-daily adjuvant oral vemurafenib 960 mg tablets for52 weeks (13×28-day cycles) (n=-9)

vs.

placebo (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

PFS 0.51 [0.39; 0.67] median 9.9 mo vs. 6.2 mo

vemurafenib and cobimetinib (n=-9)

vs.

vemurafenib and placebo (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration: