February 22, 2024

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Cancer-Free Survival Doubles: Merck Announces Positive Phase 3 Clinical Results

Cancer-Free Survival Doubles: Merck Announces Positive Phase 3 Clinical Results



Cancer-Free Survival Doubles: Merck Announces Positive Phase 3 Clinical Results for Keytruda, a PD-1 Inhibitor

On Jan 27, Merck (MSD) unveiled the significant results of the Phase 3 clinical trial, AMBASSADOR, studying Keytruda as an adjuvant therapy for treating high-risk locally muscle-invasive urothelial carcinoma (MIUC) and locally advanced resectable urothelial carcinoma. The trial successfully achieved one of its primary endpoints by markedly improving patients’ Disease-Free Survival (DFS).

In the initial pre-scheduled interim analysis with a median follow-up of 22.3 months, patients undergoing surgical treatment in the Keytruda group demonstrated a 31% reduction in the risk of disease recurrence or death compared to the postoperative observation group.

The median DFS for the Keytruda group was 29.0 months, whereas the observation group was 14.0 months, resulting in a prolongation of DFS by 15 months. These DFS outcomes remained consistent across all levels of PD-L1 expression in patients.

Another primary endpoint of the study, Overall Survival (OS), did not reach statistical significance in this interim analysis. At a median follow-up time of 36.9 months, the Keytruda group showed a median OS of 50.9 months, while the observation group had 55.8 months.

The trial will continue until data maturity. It is worth noting that 76 patients (22%) in the observation group received immune checkpoint inhibitor therapy after experiencing DFS events.

Cancer-Free Survival Doubles: Merck Announces Positive Phase 3 Clinical Results

(source:internet, reference only)


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