Melanoma: nivolumab/ipilimumab yields durable OS benefit in CheckMate 067

  • Hodi FS & al.
  • Lancet Oncol
  • 18 Oct 2018

  • curated by Brian Richardson, PhD
  • Univadis Clinical Summaries
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Takeaway

  • 4 years of follow-up to the phase 3 CheckMate 067 trial indicate improved survival outcome of patients with advanced melanoma treated with first-line nivolumab+ipilimumab or nivolumab alone.

Why this matters

  • This report presents updated efficacy and safety data of CheckMate 067, which had previously shown significant benefits in response and survival outcomes for ipilimumab+nivolumab or nivolumab monotherapy vs ipilimumab monotherapy.

Key results

  • Nivolumab+ipilimumab was associated with superior OS compared with ipilimumab alone (median OS not reached vs 19.9 months; HR, 0.54; P<.0001>
  • Nivolumab alone was associated with superior OS compared with ipilimumab alone (median OS, 36.9 vs 19.9 months; HR, 0.65; P<.0001>
  • Treatment-related grade 3/4 adverse events were reported in 59% of nivolumab+ipilimumab patients, 22% of nivolumab-alone patients, and 28% of ipilimumab-alone patients.
  • There were 2 treatment-related deaths in the nivolumab plus ipilimumab group, 1 in the nivolumab-alone group, and 1 in ipilimumab-alone group.

Study design

  • 945 patients with stage III/IV melanoma were randomly assigned to nivolumab+ipilimumab (n=314), nivolumab alone (n=316), or ipilimumab alone (n=315), and were analyzed for survival and safety outcomes during a median 46.9-month follow-up.
  • Funding: Bristol-Myers Squibb.

Limitations

  • No statistical comparison between nivolumab+ipilimumab and nivolumab alone.

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