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atezolizumab plus SoC (n=256) vs. placebo plus SoC (n=258)
randomized controlled trial
atezolizumab plus cobimetinib plus vemurafenib
intravenous atezolizumab 840 mg (day 1 and 15) and twice daily oral vemurafenib 960 mg for 21 days plus oncedaily oral cobimetinib 60 mg followed by either twice daily vemurafenib 720 mg in the atezolizumab group or 960 mg for 7 days in the control group. THEN in cycle 2 twice daily vemurafenib 720 mg, and once daily cobimetinib 60 mg (21 days on–7 days off)
placebo plus cobimetinib plus vemurafenib
intravenous placebo (day 1 and 15) and twice daily oral vemurafenib 960 mg for 21 days plus oncedaily oral cobimetinib 60 mg followed by either twice daily vemurafenib 720 mg in the atezolizumab group or 960 mg for 7 days in the control group. THEN in cycle 2 twice daily vemurafenib 720 mg, and once daily cobimetinib 60 mg (21 days on–7 days off)
Patients in the control arm are not eligible for crossover to the treatment arm at diseaseprogression.
mML - L1 - BRAF mutant
Patients with untreated or actively progressing brain metastases, active malignancy other than melanoma, or history of serious autoimmune disease were excluded.
double-blind
112 institutes in 20 countries
P3/two sided and No interim analysis for primary EP. Hierarchical testing procedure (PFS then OS)
The addition of atezolizumab to targeted therapy with vemurafenib and cobimetinib was safe and tolerable and significantly increased progression-free survival in patients with BRAF
atezolizumab plus cometinib (n=222) vs. pembrolizumab alone (n=224)
randomized controlled trial
cometinib plus atezolizumab
cobimetinib (60 mg once daily, days 1-21) plus intravenous atezolizumab (840 mg, days 1 plus 15) in 28-day cycles
pembrolizumab
intravenous pembrolizumab (200 mg every 3 weeks)
Dose reductions for atezolizumab or pembrolizumab were not permitted.
mML - L1 - BRAF wild
open label
multicenter
P3/ two sided and no interim analysis. Hierarchical testing procedure (PFS(IRC) then OS then ORR)
Cobimetinib plus atezolizumab did not improve PFS compared with pembrolizumab monotherapy in patients with BRAF mutation
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