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BRAF/MEK inhibitor combination extends PFS in melanoma
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A phase 3 study designed to evaluate combined BRAF and MEK inhibition in patients with BRAF–mutant advanced, unresectable or metastatic melanoma met its primary endpoint, according to data released by the drugs’ manufacturers.
The combination of encorafenib (LGX818, Array BioPharma), a BRAF inhibitor, and binimetinib (MEK162, Array BioPharma), a MEK inhibitor, significantly extended PFS compared with monotherapy with the BRAF inhibitor vemurafenib (Zelboraf, Genentech).
In the first part of the COLUMBUS study, researchers randomly assigned 577 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutations to 450 mg encorafenib plus 45 mg binimetinib; 300 mg encorafenib alone; or 960 mg vemurafenib alone.
Patients assigned the encorafenib–binimetinib combination achieved significantly longer median PFS than those assigned vemurafenib alone (14.9 months vs. 7.3 months; HR = 0.54; 95% CI, 0.41-0.71). Patients assigned the combination also achieved longer median PFS than those assigned encorafenib alone, but the difference did not reach statistical significance (14.9 months vs. 9.6 months; HR = 0.75; 95% CI, 0.56-1).
The combination appeared well tolerated, and adverse events were consistent with prior investigations of the combination in patients with BRAF–mutant melanoma.
“We are very pleased with the COLUMBUS part 1 results and look forward to the possibility that, if approved, the combination of encorafenib plus binimetinib could offer a new treatment option for patients suffering from this devastating disease,” Frédéric Duchesne, CEO of the pharmaceutical division at Pierre Fabre, said in a press release.
Additional results from the first part of the study — including data related to objective response rate, disease control rate and safety endpoints — will be presented at an upcoming medical meeting.
Data from the second part of the study — in which 344 patients were randomly assigned 3:1 to the combination therapy or encorafenib monotherapy — likely will be available in the middle of next year.
Editor’s Note: On Sept. 28, we corrected information provided on MEK162 to list its manufacturer as Array Biopharma. The Editors regret this error.