Melanoma: questionable benefit for pembrolizumab with dabrafenib/trametinib

  • Ascierto PA & al.
  • Nat Med
  • 6 Jun 2019

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

  • Adding pembrolizumab to dabrafenib/trametinib yielded a numerical improvement in PFS and extended duration of response, accompanied by a more than doubled rate of grade 3-5 adverse events.

Why this matters

  • Better therapies are needed for BRAF-mutated melanoma, but this trial did not reach its endpoint of a statistically significant improvement in PFS.

Key results

  • Triplet therapy with dabrafenib/trametinib/pembrolizumab triplet numerically improved PFS vs doublet therapy with dabrafenib/trametinib (16.0 vs 10.3 months; HR, 0.66; P=.043), but failed to meet the primary endpoint for statistical significance (P=.0025).
  • Triplet therapy was associated with longer duration of response compared with doublet therapy (18.7 vs 12.5 months).
  • Triplet therapy was associated with a higher rate of grade 3-5 treatment-related adverse events (58.3% vs 26.7%).
    • 1 patient who received triplet therapy died of pneumonitis.

Study design

  • Phase 2 trial of 120 patients with BRAF-mutated melanoma receiving dabrafenib/trametinib with pembrolizumab (n=60) or placebo (n=60).
  • Funding: Merck & Co., Inc., Kenilworth, NJ, USA.

Limitations

  • Small sample size.
  • Short follow-up period.

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