Nivolumab has similar efficacy and safety outcomes in patients with wild-type or mutant BRAF metastatic melanoma, regardless of prior treatment with a BRAF inhibitor or ipilimumab, a recent study published in JAMA Oncology.
For the study, researchers conducted a pooled analysis from four clinical trials of nivolumab that included 440 adult patients with unresectable stage III or stage IV melanoma. All patients had been tested for BRAF mutational status and results showed that 334 were BRAF wild-type and 106 were BRAF V600 mutation-positive. The majority of patients received nivolumab 3mg/kg intravenously over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, withdrawal, or end of study.
Results showed that the objective response rates were 34.6% (95% CI: 28.3-41.3) for the 217 evaluable patients with wild-type BRAF status and 29.7% (95% CI: 19.7-41.5) for the 74 evaluable patients with mutant BRAF status. Researchers found that objective response rates were not impacted by prior therapy with a BRAF inhibitor, ipilimumab, or PD-L1 tumor status.
In regard to safety, treatment-related adverse events of any grade occurred in 68.3% in the wild-type BRAF group compared with 58.5% in the mutant BRAF group.
The activity of nivolumab in subgroups of patients with tumors which have wild-type Importance BRAF kinase vs patients with tumors having mutant BRAF has not systematically been explored in a large dataset.