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Long-Term Findings From EORTC1325/KEYNOTE-054 Show Adjuvant KEYTRUDA Demonstrated a Sustained Recurrence-Free Survival Benefit Versus Placebo Across Stage IIIA (>1 mm Lymph Node Metastasis), IIIB and IIIC Melanoma
Merck Is Advancing a Broad Clinical Program Evaluating KEYTRUDA for the Early Treatment of Cancer
KENILWORTH, N.J., & BRUSSELS--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and the European Organisation for Research and Treatment of Cancer (EORTC) today announced 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]; p1 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]; p1 mm lymph node metastasis], IIIB and IIIC). The co-primary endpoints are RFS for all patients and RFS in patients whose tumors expressed PD-L1. Secondary endpoints include DMFS and overall survival (OS) in all patients and in patients whose tumors expressed PD-L1. Data from a three-year analysis of RFS were presented in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. In accordance with the trial protocol, the study is continuing in order to evaluate the secondary endpoint of OS; however, upon documented recurrence, patients were eligible for crossover/re-challenge with KEYTRUDA.
Key Subgroup Analysis Results From EORTC1325/KEYNOTE-054 | ||||||||
| 3.5-Year DMFS Rate, % | DMFS, HR | P-Value (Log Rank)* | |||||
PD-L1 Positive (n=853) | KEYTRUDA | 66.7% |
| 0.61 (95% CI, 0.49-0.76) |
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