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.
Continue reading BioPharma publishes phase III COLUMBUS data of encorafenib and binimetinib
To access this members-only content, please log in.
If you're not a subscriber why not join today?
If you believe you should be able to view this area but cannot log in, then please contact us
and we will try to rectify this issue as soon as possible.
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.