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Nivolumab extends survival in resected, high-risk melanoma
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Nivolumab prolonged RFS compared with ipilimumab among patients with advanced melanoma who had undergone resection, according to an interim analysis of a randomized phase 3 trial.
The ongoing double blind CheckMate -238 trial is designed to compare the safety and efficacy of the PD-1 inhibitor nivolumab (Opdivo, Bristol-Myers Squibb) with the CTLA-4 inhibitor ipilimumab (Yervoy, Bristol-Myers Squibb) in 906 patients with stage IIIb/c or stage IV melanoma who are at high risk for recurrence after complete surgical resection.
Researchers randomly assigned patients to 3 mg/kg nivolumab every 2 weeks or 10 mg/kg ipilimumab every 3 weeks for four doses, followed by every 12 weeks until documented disease progression or unacceptable toxicity. Treatment continued for up to 1 year.
RFS — defined as the time between randomization and date of first recurrence or death — served as the primary endpoint.
“These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma,” Vicki Goodman, MD, development lead of melanoma and genitourinary cancers at Bristol-Myers Squibb, said in a company-issued press release. “There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery.”
These data will be submitted for presentation at an upcoming medical conference.
“We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon,” Goodman said.