Table 1.
Trial characteristics and reported outcomes.
| Author | Study Dates | Region | Trial Design | Treatment Regimen | OS (median mos), Combination vs. Monotherapy | PFS (median mos), Combination vs. Monotherapy | ORR, Combination vs. Monotherapy | Follow-up (median mos), Combination vs. Monotherapy |
|---|---|---|---|---|---|---|---|---|
| Dummer et al. 2018 [13] | December 2013–April 2015 | Worldwide (162 centers, 28 countries) |
Phase III encorafenib + binimetinib (N = 192) vs. vemurafenib (N = 191) | 450 mg qd + 45 mg bid vs. 960 mg bid | 33.6 vs. 16.9 | 14.9 vs. 7.3 | 63% vs. 40% | 16.7 vs. 14.4 |
| Robert et al. 2015 [12] | June 2012–October 2013 | Worldwide (193 centers) | Phase III dabrafenib + trametinib (N = 352) vs. vemurafenib (N = 352) | 150 mg bid + 2 mg qd vs. 960 mg bid | (NA), 17.2 | 11.4 vs. 7.3 | 64% vs. 51% | 11 vs. 19 |
| Long et al. 2017 [11] | May 2012–November 2012 | Worldwide (113 centers, 14 countries) | Phase III dabrafenib + trametinib (N = 211) vs. dabrafenib (N = 212) | 150 mg bid + 2 mg qd vs. 150 mg bid | 25.1 vs. 18.7 | 11.0 vs. 8.8 | 68% vs. 55% | 9 (all groups) |
| Ascierto et al. 2016 [9] | January 2013–January 2014 | Worldwide (135 centers, 19 countries) | Phase III vemurafenib + cobimetinib (N = 247) vs. vemurafenib (N = 248) | 960 mg bid + 60 mg qd vs. 960 mg bid | 22.3 vs. 17.4 | 12.3 vs. 7.2 | 70% vs. 50% | 14.2 (all groups) |
| Flaherty et al. 2012 [10] | March 2010–July2011 | Multi-national (16 centers) | Phase I/II dabrafenib + trametinib (N = 54) vs. dabrafenib (N = 54) | 150 mg bid + 2 mg qd vs. 150 mg bid | (NA) | 9.4 vs. 5.8 | 76% vs. 54% | 14.1 (all groups) |
NA = not available; OS = overall survival; PFS = progression-free survival; ORR = objective response rate; mos = months.