Findings from open-label, phase 2 study in patients with melanoma and untreated brain metastases
WEDNESDAY, Aug. 22, 2018 (HealthDay News) — For patients with melanoma and untreated brain metastases, nivolumab combined with ipilimumab shows clinically meaningful efficacy, according to a study published in the Aug. 23 issue of the New England Journal of Medicine.
Hussein A. Tawbi, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted an open-label, multicenter, phase 2 study involving 94 patients with metastatic melanoma and at least one measurable, non-irradiated brain metastasis. Participants received nivolumab plus ipilimumab every three weeks for up to four doses, followed by nivolumab every two weeks until progression or unacceptable toxic effects.
The researchers found that the rate of intracranial clinical benefit was 57 percent, and the rates of complete response, partial response, and stable disease for at least six months were 26, 30, and 2 percent, respectively, during a median follow-up of 14.0 months. There was a 56 percent rate of extracranial clinical benefit. Fifty-five percent of patients reported treatment-related grade 3 or 4 adverse events, including 7 percent with events involving the central nervous system. The safety profile of the regimen was similar to that seen in melanoma patients without brain metastases.
“Nivolumab combined with ipilimumab had clinically meaningful intracranial efficacy, concordant with extracranial activity, in patients with melanoma who had untreated brain metastases,” the authors write.
The study was funded by Bristol-Myers Squibb, the manufacturer of nivolumab and ipilimumab.
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