Initial treatment with two monoclonal antibodies significantly improves survival for patients with BRAF V600-variant advanced melanoma compared to treatment with two targeted agents, researchers reported during the November 2021 ASCO Plenary Series meeting. The initial findings were so conclusive that the study’s data safety and monitoring board stopped the trial early.
The researchers tested the treatments in 265 patients with treatment-naïve BRAF V600-variant metastatic melanoma. Patients were randomly assigned to receive either combination immunotherapy (ipilimumab and nivolumab) or combination targeted therapy (dabrafenib and trametinib) and were given the option to switch to the opposite treatment arm if their cancer progressed under the initially assigned treatment.
They found that 72% of patients who were initially treated with ipilimumab and nivolumab, even those who eventually progressed and switched to the combination targeted therapies, were still alive two years after starting treatment compared to 52% of those initially treated with dabrafenib and trametinib. When the trial was stopped, participants who were still receiving initial treatment with the targeted therapies were given the option to switch to the ipilimumab-nivolumab combination.
The combination immunotherapy was associated with a higher rate of serious adverse events, particularly when used as the initial treatment (60% versus 54%). As second-line therapy, serious adverse events occurred in 52% of patients receiving ipilimumab and nivolumab and 50% of those on dabrafenib and trametinib.
“Standard of care should immediately change because these are U.S. Food and Drug Administration-approved regimens,” the researchers said. “Physicians seeing these results should consider patients who are on initial targeted therapy for a switch to immunotherapy.”
Learn more about BRAF and its implications for oncology clinical practice with ONS’s Biomarker Quick Guide: BRAF.