News by Erik S. Lesser/Getty Images
merck (New York Stock Exchange: MRK) announced detailed results from its Phase 3 AMBASSADOR trial on Friday, noting that its anti-PD1 therapy Keytruda reduced the risk of disease recurrence or death by 31% after surgery in patients with urothelial carcinoma, a form of bladder cancer.
With a median follow-up of 22.3 months, the 702-patient trial indicated a statistically and clinically significant improvement for Keytruda in terms of disease-free survival (DFS), one of its dual primary endpoints.
However, the trial has yet to show statistically significant data for the other dual primary endpoint of overall survival (OS). When the median follow-up reached 36.9 months, the median OS for Keytruda was 50.9 months, compared with 55.8 months for the no-drug group.
Regarding tolerability, there were no new safety concerns, while ~48% of patients receiving Keytruda developed Grade ≥3 adverse events compared to ~32% in the observation group.
The AMBASSADOR trial was conducted by Merck (MRK) in partnership with Pfizer's (PFE) Seagen unit and Japanese drugmaker Astellas (OTCPK:ALPMF) (OTCPK:ALPMY).
It was designed to evaluate Keytruda as an adjuvant therapy for localized muscle-invasive urothelial carcinoma and locally advanced resectable urothelial carcinoma.
