Array BioPharma Inc. announced publication in The Lancet Oncology of the COLUMBUS trial survival results for melanoma for Braftovi + Mektovi.
Array BioPharma Inc. announced the publication of detailed overall survival (OS) results from the COLUMBUS trial in The Lancet Oncology. The pivotal Phase III trial evaluated the efficacy and safety of the combination of Braftovi+ Mektovi compared to vemurafenib monotherapy in patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. Braftovi + Mektovi reduced the risk of death compared to treatment with vemurafenib [hazard ratio (HR) of 0.61, (95% CI 0.47-0.79, p <0.0001)] in the planned analysis of os. median os was 33.6 months for patients treated with the combination compared to 16.9 months for patients treated with vemurafenib as a monotherapy. the analysis of os and updated efficacy and safety data extend findings of previously announced results. based on data from the previously reported primary analysis of the columbus trial the fd approved braftovi capsules in combination with mektovi tablets on 27 june 2018 for the treatment of patients with unresectable or metastatic melanoma with a brafv600e or brafv600k mutation as detected by an fda-approved test. braftovi is not indicated for the treatment of patients with wild-type braf melanoma. further on july 16 2018 array submitted supplementary new drug applications to seek inclusion of os data from the columbus trial in the braftovi and mektovi labels. mature median progression-free survival mpfs for braftovi mektovi was 14.9 months 95 ci 11.020.2 compared to vemurafenib with 7.3 months 5.67.9 hr 0.51 95 ci 0.390.67 two-sided p><0.0001)].>
See- "Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial."- Prof Reinhard Dummer, MD, Paolo A Ascierto, MD, Helen J Gogas, MD, Ana Arance, MD, et al., Published: September 12, 2018 -DOI:https://doi.org/10.1016/S1470-2045(18)30497-
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