publication date: Nov. 29, 2016
Melanoma Binimetinib plus encorafenib produces PFS improvement vs vemurafenib monotherapy
Array BioPharma and Pierre Fabre announced new results from the pivotal phase III COLUMBUS trial of binimetinib plus encorafenib (bini/enco) treatment in BRAF-mutant melanoma patients at the Society for Melanoma Research Annual Congress.
The study met its primary endpoint, with the combination of bini/enco significantly improving progression free survival compared with vemurafenib, a BRAF inhibitor, alone. The combination of bini/enco was generally well-tolerated and reported adverse events were overall consistent with previous published clinical trial results for the bini/enco combination in BRAF-mutant melanoma patients.
“The results presented today from the COLUMBUS trial, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of binimetinib plus encorafenib as a potential, attractive treatment option for patients diagnosed with BRAF-mutant melanoma,” said Keith T. Flaherty, director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School.
In the analysis of the primary endpoint, the median PFS (mPFS) for patients treated with the combination of bini/enco was 14.9 months versus 7.3 months for patients treated with vemurafenib; hazard ratio (HR) 0.54, (95% CI 0.41-0.71, p<0.001). As part of the trial design, the primary analysis was based on a Blinded Independent Central Review (BICR) … Continue reading CCL Nov 2016 – Binimetinib plus encorafenib produces PFS improvement vs vemurafenib monotherapy
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