This article is more than 5 years old. Information may no longer be current.
Encorafenib-binimetinib combination improves OS for advanced BRAF-mutated melanoma
Click Here to Manage Email Alerts
Combination treatment with encorafenib and binimetinib reduced the risk for death compared with vemurafenib monotherapy for patients with advanced BRAF-mutant melanoma, according to results from the COLUMBUS trial.
COLUMBUS is a phase 3 international, open-label study that randomly assigned 921 patients with BRAF-mutated locally advanced, unresectable or metastatic melanoma to the combination of 450 mg daily encorafenib (LGX818, Array BioPharma) and 45 mg twice daily binimetinib (MEK162, Array BioPharma) — together known as COMBO450 — 960 mg daily vemurafenib (Zelboraf, Genentech) monotherapy or 300 mg daily encorafenib monotherapy.
As HemOnc Today previously reported, this combination therapy improved PFS in BRAF- mutant melanoma.
From the current planned OS analysis, researchers also found that COMBO450 reduced risk for death (HR = 0.61; 95% CI, 0.47-0.79) compared with vemurafenib. Median OS was 33.6 months for combination therapy compared with 16.9 months for vemurafenib alone.
A preliminary analysis of OS among patients treated with encorafenib showed a median OS of 23.5 months.
“Many patients with BRAF-mutant melanoma still face significant challenges managing their disease, and there remains a substantial need for well-tolerated treatments that delay disease progression and improve OS,” Keith T. Flaherty, MD, director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital Cancer Center and a professor of medicine at Harvard Medical School, said in a manufacturer-issued press release.
COMBO450 appeared generally well tolerated. Grade 3 or grade 4 adverse events that occurred among more than 5% of patients included creased gamma-glutamyl transferase (9%), increased blood creatine phosphokinase (7%) and hypertension (6%).
Any-grade adverse events that may be associated with treatment included rash (23%), pyrexia (18%), retinal pigment epithelial detachment (13%) and photosensitivity (5%).
“We are excited to report these OS results from the COLUMBUS trial,” Victor Sandor, MD, chief medical officer of Array BioPharma, said in the release. “This encouraging OS finding further validates previously reported median PFS and overall response rate results, and taken together with the attractive tolerability profile, these data suggest that the combination of encorafenib with binimetinib has the potential to become a promising new treatment option for these patients.”