Durvalumab regimen improves survival in muscle-invasive bladder cancer
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The combination of durvalumab and chemotherapy improved outcomes compared with neoadjuvant chemotherapy alone for patients with muscle-invasive bladder cancer, according to the agent’s manufacturer.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
The agent is approved in the United States for several oncology indications, including treatment of certain patients with lung, bile duct, gallbladder, liver or endometrial cancers.
The randomized phase 3 NIAGARA trial included 1,063 patients with muscle-invasive bladder cancer.
Researchers randomly assigned patients to one of two regimens: neoadjuvant chemotherapy with durvalumab followed by post-cystectomy durvalumab, or neoadjuvant chemotherapy alone with no further treatment after cystectomy.
Investigators reported improvements in EFS — the study’s primary endpoint — and OS, a key secondary endpoint, among patients assigned durvalumab.
“Nearly half of patients with muscle-invasive bladder cancer who receive standard of care still experience disease recurrence or progression,” investigator Thomas Powles, MD, professor and director of Barts Cancer Centre at Queen Mary University in London, said in an AstraZeneca-issued press release. “These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives.”
Researchers observed no new safety concerns with durvalumab in the neoadjuvant or adjuvant settings.
The addition of durvalumab to chemotherapy did not increase the rate at which patients discontinued therapy due to adverse events, nor did it not alter patients’ ability to complete surgery.
Complete data from the NIAGARA trial will be presented at a medical conference.
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