Merck & Co Inc MRK announced results from the Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial of Keytruda for the adjuvant treatment of high-risk patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced resectable urothelial carcinoma.
The data are being presented for the first time at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) 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 (DFS), reducing the risk of disease recurrence or death by 31% versus observation in these patients after surgery.
Median DFS was 29.0 months for 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 (OS) did not reach statistical significance at this interim analysis and will continue to be followed as data mature.
After a median follow-up of 36.9 months, the median OS was 50.9 months for Keytruda versus 55.8 months for observation.
The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
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