- Merck (NYSE:MRK) and the European Organisation for Research and Treatment of Cancer (EORTC) announce new and updated findings from the Phase 3 EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma.
- Late-breaking, first-time study results showed that with 3.5 years of follow-up, adjuvant KEYTRUDA met the key secondary endpoint of distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 40% versus placebo (HR=0.60 [95% CI, 0.49-0.73]; p<0.001), with 3.5-year DMFS rates of 65.3% and 49.4%, respectively.
- In addition, KEYTRUDA demonstrated a sustained recurrence-free survival (RFS) benefit versus placebo across stage IIIA (>1 mm lymph node metastasis), IIIB and IIIC melanoma, with 3.5-year RFS rates of 59.8% for KEYTRUDA versus 41.4% for placebo (HR = 0.59 [95% CI, 0.49-0.70]; p<0.001).
- The RFS and DMFS benefits were observed across key subgroups, including disease stages (both according to AJCC-7 and AJCC-8), BRAF mutation status and PD-L1 expression.
- KEYTRUDA also continued to demonstrate long-term improvements in the prevention of new disease compared to placebo, with nearly 60% of patients alive and recurrence-free after 3.5 years.
- These data were presented as a proffered paper at ESMO Virtual Congress 2020. A compendium of presentations and posters of Merck-led studies is available here.
- In addition, the DMFS benefit demonstrated with KEYTRUDA was similar in patients with AJCC-7 stage IIIA (HR=0.64), IIIB (HR=0.58) and IIIC (HR=0.61) melanoma.
- Adjuvant KEYTRUDA decreased the incidence of distant metastasis as a first recurrence by 43% (at 3.5 years: 24.9% versus 39.5%, HR= 0.57 [95% CI, 0.46-0.72]; p<0.001).
- No new safety data were identified as part of the 42-month analysis.