A Phase 3 clinical trial, DANUBE, evaluating the combination of AstraZeneca’s (NYSE:AZN)
Imfinzi (durvalumab) and anti-CTLA-4 monoclonal antibody tremelimumab
for the first-line treatment of patients with unresectable metastatic
bladder cancer failed to meet the primary endpoint of overall survival (OS) versus chemo in patients with high PD-L1-expressing cancer or regardless of their PD-L1 expression.
No new safety signals were observed.
Imfinzi is approved in 15 countries for the second-line treatment of bladder cancer.
The company has three other bladder cancer Phase 3 studies in process: POTOMAC (Imfinzi + BCG), NIAGARA (Imfinzi + chemo in neoadjuvant setting) and NILE (IMFINZI + chemo vs. Imfinzi + tremelimumab + chemo vs. chemo).
Shares down 1% premarket on light volume.
https://seekingalpha.com/news/3549334-astrazenecas-imfinzi-doublet-therapy-flunks-late-stage-bladder-cancer-study
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