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Pooled Analysis of Outcome With Nivolumab Alone or With Ipilimumab in Advanced Mucosal or Cutaneous Melanoma

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Key Points

  • Among patients with mucosal melanoma, median progression-free survival was 3.0 months with monotherapy and 5.9 months with combined therapy.
  • Among patients with mucosal melanoma, treatment-related grade 3 or 4 adverse events occurred in 8.1% with nivolumab monotherapy and 40.0% with nivolumab combined with ipilimumab therapy.

A pooled analysis of outcomes in patients receiving nivolumab (Opdivo) or nivolumab plus ipilimumab (Yervoy) for advanced mucosal or cutaneous melanoma in clinical trials was reported by D’Angelo et al in the Journal of Clinical Oncology.

The pooled analysis involved 889 patients who received nivolumab monotherapy, including 86 (10%) with mucosal melanoma and 665 (75%) with cutaneous melanoma, and 361 patients who received nivolumab plus ipilimumab, including 35 (10%) with mucosal melanoma and 326 (90%) with cutaneous melanoma.

Progression-Free Survival and Response Rates

Among patients who received nivolumab monotherapy, median progression-free survival was 3.0 months (95% confidence interval [CI] = 2.2–5.4 months) in those with mucosal melanoma and 6.2 months (95% CI = 5.1–7.5 months) in those with cutaneous melanoma. Objective response rates were 23.3% (95% CI = 14.8%–33.6%) and 40.9% (95% CI = 37.1%–44.7%).

Among patients receiving combined therapy, median progression-free survival was 5.9 months (95% CI, 2.8 months to not reached) in those with mucosal melanoma and 11.7 months (95% CI = 8.9–16.7 months) in those with cutaneous melanoma. Objective response rates were 37.1% (95% CI = 21.5%–55.1%) and 60.4% (95% CI = 54.9%–65.8%).

Adverse Events

The incidence of treatment-related grade 3 or 4 adverse events was 8.1% among patients with mucosal melanoma and 12.5% among those with cutaneous melanoma receiving nivolumab monotherapy; among those receiving combined therapy, the incidence was 40.0% in patients with mucosal melanoma and 54.9% in those with cutaneous melanoma.

The investigators concluded: “To our knowledge, this is the largest analysis of data for anti–programmed death-1 therapy in mucosal melanoma to date. Nivolumab combined with ipilimumab seemed to have greater efficacy…, and although the activity was lower in mucosal melanoma, the safety profile was similar between subtypes.”

The study was supported by Bristol-Myers Squibb.

Sandra P. D’Angelo, MD, of Memorial Sloan Kettering Cancer Center

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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