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FDA approves Opdivo for resected melanoma
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The FDA approved nivolumab injection for the adjuvant treatment of patients with melanoma who have involved lymph nodes or metastatic disease and who underwent complete resection.
Nivolumab (Opdivo, Bristol-Myers Squibb) is the first anti-PD-1 immune checkpoint inhibitor indicated for the adjuvant treatment of melanoma. This approval includes patients with mutated and wild-type BRAF.
The FDA based the approval on results from the phase 3 randomized double-blind CheckMate 238 trial, which enrolled 906 patients with complete resection of stage IIIB/C or stage IV melanoma.
Researchers assigned patients 1:1 to nivolumab (3 mg/kg every 2 weeks) or ipilimumab (10 mg/kg every 3 weeks for four doses, then every 12 weeks starting at week 24).
A higher percentage of patients assigned nivolumab achieved 18-month RFS (66.4% vs. 52.7%). Nivolumab reduced the risk for disease recurrence by 35% (HR = 0.65; 95% CI, 0.53-0.8).
Adverse events leading to discontinuation occurred among 9% of patients assigned nivolumab compared with 42% of patients assigned ipilimumab. Grade 3 or grade 4 adverse events occurred among 25% of patients assigned nivolumab and 55% of patients assigned ipilimumab.
“Today’s approval builds on our leadership in melanoma, offering physicians a new option with the potential to change the course of the disease through earlier intervention. Opdivo is the first PD-1 inhibitor approved as an adjuvant treatment for any cancer,” Johanna Mercier, head of U.S. Commercial at Bristol-Myers Squibb, said in a press release. “Our decision to study Opdivo vs. Yervoy — an established standard of care with a proven survival benefit — represents our relentless pursuit to bring more effective treatments to patients.”
Based on these data, the National Comprehensive Cancer Network added nivolumab to its treatment guidelines for completely resected stage IIIB/C melanoma and completely resected stage III melanoma with clinical satellite or in-transit metastases.
“Immuno-oncology has transformed the treatment of metastatic melanoma and many other cancers over the last decade, and we are now extending the use of novel agents to help prevent the recurrence of melanoma,” Jeffrey S. Weber, MD, PhD, deputy director of the Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, and professor of medicine at NYU School of Medicine, said in the release. “When melanoma has been removed surgically, physicians and patients alike sometimes struggle with the idea of further adjuvant treatment because the disease is no longer detectable, even though it may be likely to return. We recognized a need to develop new adjuvant treatments with lower toxicity compared to ipilimumab to help address this challenge.
“With its impressive efficacy and broad applicability within stage III and stage IV melanoma, nivolumab has the potential to become the next standard of care in preventing recurrence of melanoma following surgical resection,” Weber added.