A recent study reviewed the outcomes of part 1 and part 2 of the COLUMBUS study, in which patients with advanced BRAFV600-mutant melanoma were randomly assigned 1:1:1 to encorafenib 450 mg once daily plus binimetinib 45 mg twice a day (COMBO450), vemurafenib 960 mg twice a day, or encorafenib 300 mg once daily (ENCO300). Part 2, requested by the FDA, evaluated the contribution of binimetinib by maintaining the same encorafenib dosage in the combination (encorafenib 300 mg once daily plus binimetinib 45 mg twice daily [COMBO300]) and ENCO300 arms. Two hundred fifty-eight patients received COMBO300, and 86 received ENCO300. The researchers concluded that COMBO300 improved progression-free survival, overall response rate, and tolerability vs ENCO300, verifying the contribution of binimetinib to efficacy and safety.
Reference: Ascierto PA, Dummer R, Gogas HJ, et al. Contribution of MEK Inhibition to BRAF/MEK Inhibitor Combination Treatment of BRAF-Mutant Melanoma: Part 2 of the Randomized, Open-Label, Phase III COLUMBUS Trial. J Clin Oncol. 2023:JCO2202322. doi: 10.1200/JCO.22.02322.