EORTC 1325-MG/Keynote-054: 7-year update

Based on previous results of the randomized, phase III EORTC 1325-MG/Keynote-054 study, pembrolizumab became a standard adjuvant treatment following a resection in patients with a high-risk, stage III melanoma. In this video, Prof Dr Jeroen Mebis (Jessa Hospital, Hasselt) discusses the 7-year update of this trial which was presented as a poster during the 2024 annual ESMO meeting.

In this trial, 1,019 adult melanoma patients with AJCC-7 stage IIIA and a lymph node metastasis >1 mm or IIIB/C without in-transit metastases were randomized to receive adjuvant pembrolizumab (200 mg q3w) or placebo. After a median follow of approximately 7 years, adjuvant pembrolizumab continued to be associated with a significantly better recurrence-free (7-year rates: 50% vs. 36%; HR[95%CI]: 0.63[0.53-0.74]), distant metastasis-free (7-year rates: 54% vs. 42%; HR[95%CI]: 0.64[0.54-0.76]) and second progression-free survival (7-year rates: 61% vs. 53%; HR[95%CI]: 0.69[0.57-0.84]) than placebo.

As such, these long-term data solidify adjuvant pembrolizumab as a standard of care following a resection in patients with a high-risk stage III melanoma.