pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
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melanoma | encorafenib plus binimetinib | 1L | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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COLUMBUS, 2018 | encorafenib plus binimetinib vs vemurafenib | PFS 0.54 [0.41; 0.71] | | |
Trial | Treatments | Patients | Method |
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COLUMBUS, 2018 | 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) | patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation | open label Sample size: 192/191 Primary endpoint: Progression free survival FU duration: 16.6 mo (median) |
|
melanoma | trametinib + dabrafenib | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Flaherty, 2012 | trametinib and dabrafenib vs dabrafenib | PFS 0.39 [0.25; 0.61] median 9.4 mo vs. 5.8 mo | | |
Trial | Treatments | Patients | Method |
---|
Flaherty, 2012 | dabrafenib (150 mg) plus trametinib (1 or 2 mg) (n=162) vs. dabrafenib monotherapy (n=-9) | patients with metastatic melanoma and BRAF V600 mutations | Sample size: 162/-9 Primary endpoint: FU duration: phase 2 |
|
melanoma | trametinib + dabrafenib | 1L | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
COMBI-V (Robert), 2015 | trametinib and dabrafenib vs vemurafenib | OS 0.69 [0.53; 0.89] PFS 0.56 [0.46; 0.69] median 11.4 mo vs. 7.3 mo | | |
Trial | Treatments | Patients | Method |
---|
COMBI-V (Robert), 2015 | (n=-9) vs. (n=-9) | patients with metastatic melanoma with a BRAF V600 mutation | Sample size: -9/-9 Primary endpoint: FU duration: |
|
melanoma | trametinib + dabrafenib | 1L unresectable | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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COMBI-D (Long), 2014 | trametinib and dabrafenib vs dabrafenib | OS 0.63 [0.42; 0.94] PFS 0.75 [0.57; 0.99] | | |
Trial | Treatments | Patients | Method |
---|
COMBI-D (Long), 2014 | dabrafenib and trametinib (n=423) vs. dabrafenib monotherapy (n=0) | previously untreated patients who had unresectable stage IIIC or stage IV melanoma with a BRAF V600E or V600K mutation | Sample size: 423/0 Primary endpoint: Progression-Free Survival FU duration: |
|
melanoma | trametinib + dabrafenib | adjuvant | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
COMBI-AD, 2017 | trametinib and dabrafenib vs placebo | OS 0.57 [0.42; 0.78] PFS 0.47 [0.39; 0.57] distant metastasis free survival 0.51 [0.40; 0.65] | | | COMBI neo, 2018 | trametinib and dabrafenib vs SOC | | | |
Trial | Treatments | Patients | Method |
---|
COMBI-AD, 2017 | dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months (n=-9) vs. placebo (n=-9) | Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma | double-blind Sample size: -9/-9 Primary endpoint: Relapse-free survival FU duration: | COMBI neo, 2018 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
melanoma | vemurafenib and cobimetinib | not classified | versus 1L unresectable No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Larkin, 2014 | vemurafenib and cobimetinib vs vemurafenib | PFS 0.51 [0.39; 0.67] median 9.9 mo vs. 6.2 mo | | |
Trial | Treatments | Patients | Method |
---|
Larkin, 2014 | vemurafenib and cobimetinib (n=-9) vs. vemurafenib and placebo (n=-9) | patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma | Sample size: -9/-9 Primary endpoint: FU duration: |
|