publication date: Mar. 23, 2018

Clinical Roundup

BioPharma publishes phase III COLUMBUS data of encorafenib and binimetinib

Array BioPharma Inc. published the results of its phase III COLUMBUS trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma were published in The Lancet Oncology.

In the analysis of the primary endpoint, the median progression-free survival for patients treated with the combination of encorafenib, 450 mg daily, plus binimetinib, 45 mg twice daily, (COMBO450) was 14.9 months versus 7.3 months for patients treated with vemurafenib, 960 mg twice daily [hazard ratio (HR) 0.54, 95% CI 0.41– 0.71; p<0.0001)].

The manuscript is titled “Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase III trial. Array previously announced top line results from this study in September 2016.

The combination of encorafenib and binimetinib was generally well-tolerated. The median duration of treatment was 51.2 weeks (27.1-79.7) for encorafenib and 50.6 weeks (26.1-79.7) for binimetinib. The median dose intensity was 100% (93-100) of planned doses of encorafenib and 99.6% (80-100) of planned doses of binimetinib. The most common grade III/IV adverse events  seen in more than 5% of patients were increased gamma-glutamyltransferase 9% (18/192 patients), increased creatine phosphokinase 7% (13), and hypertension 6% (11) in the encorafenib plus binimetinib group.

The FDA is currently reviewing the New Drug Applications to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

The FDA set a target action date under the Prescription Drug User Fee Act of June 30, 2018 for both applications. In addition, the European Medicines Agency, as well as the … Continue reading BioPharma publishes phase III COLUMBUS data of encorafenib and binimetinib

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