Results of Pembrolizumab in High-Risk Stage III Melanoma

Alexander M. M. Eggermont, MD, PhD

Alexander M. M. Eggermont, MD, PhD, director general of Gustave Roussy Cancer Campus Grand Paris in Villejuif, France, discusses the phase III results from the EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting.

Alexander M. M. Eggermont, MD, PhD, director general of Gustave Roussy Cancer Campus Grand Paris in Villejuif, France, discusses the phase III results from the EORTC 1325-MG/KEYNOTE-054 trial presented at the 2018 AACR Annual Meeting.

The EORTC 1325-MG/KEYNOTE-054 trial showed that adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence or death by 43% in patients with resected, high-risk stage III melanoma.

At a median follow-up of 15 months, the 1-year recurrence-free survival (RFS) rate was 75.4% (95% CI, 71.3-78.9) with the PD-1 inhibitor versus 61.0% (95% CI, 56.5-65.1) with placebo (HR, 0.57; 98.4% CI, 0.43-0.74;P<.0001). The RFS benefit was observed regardless of PD-L1 orBRAF&nbsp;mutation status.

RFS was the primary endpoint in the overall population and in PD-L1—positive patients. The 18-month RFS rate was 71.4% (95% CI, 66.8-75.4) with pembrolizumab versus 53.2% with placebo (95% CI, 47.9-58.2).