The COLUMBUS Trial in BRAF-Mutant Melanoma

Source: OncLive, June 2019

Transcript:

Hussein A. Tawbi, MD: The COLUMBUS trial was a study that had a phase III component that randomized patients to encorafenib and binimetinib versus single-agent encorafenib versus single-agent vemurafenib. And obviously in that phase III trial, the single-agent vemurafenib was kind of the standard-of-care arm that the combination was expected to be compared with. And so in that study, the encorafenib and binimetinib combination ended up being, showed a better efficacy profile, and the progression-free survival rate was about 14.9 months. The progression-free survival, I should say, not the survival rate, was 14.9 months as compared with 7.2 months for the vemurafenib. And that’s really important, because that was the primary endpoint of the study, the progression-free survival.

The other piece that we feel is very important to kind of help us understand the results of that trial, is actually the standard-of-care vemurafenib arm, because that is the one that was, again, studied in other trials—like when vemurafenib and cobimetinib were compared with vemurafenib alone and dabrafenib and trametinib were also compared with vemurafenib alone. So it’s kind of a way to anchor the results of multiple trials. That arm seemed to actually do just as well as the other vemurafenib arms in the other studies. And so it kind of gives us an inclination to believe that that trial population was about similar to the other trials that studied BRAF and MEK inhibitors.

And so, again, for the results of the immediate trial it was clear that encorafenib and binimetinib were more efficacious than vemurafenib alone in terms of improving PFS [progression-free survival] and actually later on in terms of improving overall survival as well.