Updated phase III COLUMBUS trial data of Braftovi + Mektovi presented at ASCO.

Array BioPharma announced that that it will present data from the Phase III COLUMBUS Trial of Braftovi + Mektovi (encorafenib + binimetinib) in advanced BRAF-mutant melanoma in an oral poster discussion on June 3, 2019, at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). Landmark overall survival (OS) and progression-free survival (PFS), as well as subgroup analyses and updated safety and tolerability, will be presented. Across arms, median follow-up for OS was 48.6 months, with a median OS of 33.6 months (95% CI, 24.4–39.2) for Braftovi, 450 mg daily + Mektovi, 45 mg twice daily, compared to 16.9 months (95% CI, 14.0–24.5) for vemurafenib, consistent with prior readouts. Compared to vemurafenib, Braftovi, 450 mg daily + Mektovi, 45 mg twice daily, decreased the risk of death by 39% (HR, 0.61 [95% CI, 0.48–0.79]).

Updated median progression-free survival (PFS) also remained consistent and was 14.9 months (95% CI, 11.0–20.2) with Braftovi, 450 mg daily + Mektovi, 45 mg twice daily, compared to 7.3 months (95% CI, 5.6–8.2) with vemurafenib (HR, 0.52 [95% CI, 0.40–0.67]).

Comment: The COLUMBUS trial (NCT01909453) is a two-part, international, randomized, open label Phase III trial evaluating the efficacy and safety of the combination compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. All secondary efficacy analyses, including overall survival, are descriptive in nature. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial.