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