Takeaway
- In patients with high-risk stage III melanoma, adjuvant treatment with 200 mg of pembrolizumab (Keytruda) administered every 3 wks for up to 1 yr resulted in significantly longer recurrence-free survival than placebo.
- No new toxic effects were identified.
Why this matters
- These data provide more evidence that programmed death 1 (PD-1) inhibitors that are effective in advanced melanoma also have effectiveness as adjuvant therapy.
Key results
- At median follow-up of 15 months, pembrolizumab was associated with a 1-yr recurrence-free survival rate of 75.4% vs. 61.0% with placebo in the overall intention-to-treat population (hazard ratio [HR] for recurrence or death 0.57; 98.4% CI 0.43-0.74; P<.001).
- In the subgroup of 853 patients with PD-Ligand 1-positive tumours, 1-yr recurrence-free survival was 77.1% in the pembrolizumab group and 62.6% in the placebo group (HR 0.54; 95% CI 0.42-0.69; P<.001).
- Treatment-related grade 3-5 adverse events were reported in 14.7% of patients receiving pembrolizumab and 3.4% of those receiving placebo.
- There was one treatment-related death (due to myositis) in the pembrolizumab group.
Study design
- Randomised, double-blind, phase 3 trial comparing adjuvant therapy with pembrolizumab 200 mg every 3 wks with placebo in patients with resected, high-risk stage III melanoma.
- Funding: Merck Sharp & Dohme Corp.
References
References