Melanoma: combining nivolumab, ipilimumab ups treatment-free survival

  • Regan MM & al.
  • J Clin Oncol
  • 9 Sep 2019

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

  • Combined nivolumab+ipilimumab is associated with improved treatment-free survival (TFS) compared with either drug alone in patients with advanced melanoma, according to pooled analysis of the CheckMate 067 and 069 trials.

Why this matters

  • TFS is a novel outcome measure based on the time between cessation of immune checkpoint inhibitors and initiation of subsequent systemic therapy or death.

Key results

  • At 36 months, rates of survival free of subsequent therapy initiation were 47% with nivolumab+ipilimumab vs 37% and 15% with nivolumab and ipilimumab alone.
    • OS rates were 72%, 69%, and 59%, respectively.
  • Nivolumab+ipilimumab was associated with longer restricted mean TFS (11.1 months) than nivolumab alone (4.6 months) or ipilimumab alone (8.7 months).
    • Restricted mean TFS without grade 3+ treatment-related adverse events was 10.1, 4.1, and 8.5 months, respectively.

Study design

  • Pooled data from 1077 patients enrolled in 2 randomized, double-blind trials of nivolumab and ipilimumab. 
  • TFS analysis was restricted at 36 months.
  • Funding: Bristol-Myers Squibb; National Cancer Institute; Yale University; ONO Pharmaceutical Co.

Limitations

  • Different treatment regimens between pooled trials.
  • QoL not analyzed.
  • Lack of statistical analysis.