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Combination of binimetinib, encorafenib extends PFS in advanced BRAF–mutated melanoma
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The addition of binimetinib to encorafenib extended PFS among patients with BRAF–mutant advanced, unresectable or metastatic melanoma, according to topline results of the COLUMBUS trial.
The two-part, randomized phase 3 trial evaluated the efficacy and safety of binimetinib (MEK162, Array), a MEK inhibitor, plus encorafenib (LGX818, Array), a BRAF inhibitor, with either vemurafenib (Zelboraf, Genentech) monotherapy or encorafenib monotherapy.
The analysis included 921 patients with locally advanced, unresectable or metastatic melanoma who harbored BRAF V600 mutations.
In the second part of the study — designed to provide additional data to evaluate the contribution of binimetinib to the combination regimen — researchers randomly assigned 344 patients 3:1 to 45 mg binimetinib twice daily plus 300 mg encorafenib daily or 300 mg encorafenib daily alone.
Patients assigned the combination achieved superior median PFS (12.9 months vs. 9.2 months; HR = 0.77; 95% CI, 0.61-0.97).
The combination regimen appeared well tolerated. It exhibited a safety profile consistent with that observed in the first part of the study, which compared the combination regimen with encorafenib alone or vemurafenib along.
“The totality of the COLUMBUS results — including estimated PFS, 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 an attractive treatment option for patients diagnosed with BRAF–mutant melanoma,” Keith T. Flaherty, MD, director of Termeer Center for Targeted Therapy at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in an Array BioPharma–issued press release.
Complete results from the second part of the study will be presented at a medical meeting later this year.
Array BioPharma officials expect the company to file a new drug application in June or July, according to the press release.
“The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS part 2 once again demonstrates the combination represents a potentially important addition to the MEK/BRAF treatment landscape for patients with BRAF–mutant melanoma,” Ron Squarer, CEO of Array BioPharma, said in the press release. “The results of part 2 confirm the contribution of binimetinib to the combination.”