The primary analysis of the Columbus-AD trial is looking at the safety and efficacy of encorafenib and binimetinib in the adjuvant treatment of BRAF mutant stage 2 melanoma, primarily looking at safety. The safety profile found is very consistent with what we know for encorafenib and binimetinib in other stages of disease like in stage 4 melanoma or other indications, and it’s been a very tolerable treatment...
The primary analysis of the Columbus-AD trial is looking at the safety and efficacy of encorafenib and binimetinib in the adjuvant treatment of BRAF mutant stage 2 melanoma, primarily looking at safety. The safety profile found is very consistent with what we know for encorafenib and binimetinib in other stages of disease like in stage 4 melanoma or other indications, and it’s been a very tolerable treatment. We also performed descriptive analyses for recurrence-free and distant metastasis-free survival, showing very promising results in that end. The promising results for recurrence-free survival and distant metastasis-free survival show a trend towards a 10-20% improvement for encorafenib and binimetinib over placebo. So unfortunately, the trial recruitment has been prematurely terminated, leaving us with only 110 patients out of the 800 that were initially planned, meaning that this is no longer a registrational trial. So unfortunately, we will not go to the regulatory authorities to get formal approvals. However, in some countries, this will be possible to get access and reimbursement for encorafenib and binimetinib for this indication based off of these results. It would have been ideal to have the option to offer different treatments like PD-1 or encorafenib and binimetinib for stage 2 melanoma patients, but unfortunately we’ll have to wait for another BRAF/MEK combination compound to come through in the future.
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