Merck announces results from Phase 3 AMBASSADOR/KEYNOTE-123 trial

Merck announced results from the Phase 3 AMBASSADOR/KEYNOTE-123 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of high-risk patients with localized muscle-invasive urothelial carcinoma and locally advanced resectable urothelial carcinoma. These late-breaking data are being presented for the first time today during an oral abstract session at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium. At the trial’s first pre-specified interim analysis, after a median follow-up of 22.3 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in one of the study’s dual primary endpoints of disease-free survival, reducing the risk of disease recurrence or death by 31% versus observation in these patients after surgery. Median DFS was 29.0 monthsfor KEYTRUDA and 14.0 months for observation, an improvement of 15 months. These DFS results were consistent regardless of patients’ PD-L1 expression status. The trial’s other dual primary endpoint of overall survival did not reach statistical significance at the time of this interim analysis and will continue to be followed as data mature. After a median follow-up of 36.9 months, median OS was 50.9 months for KEYTRUDA versus 55.8 months for observation. Merck has an extensive clinical development program evaluating KEYTRUDA as monotherapy and in combination with other anti-cancer therapies across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic.