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The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) for adult patients with muscle-invasive bladder cancer (MIBC).
The FDA approval was based on results from the NIAGARA Phase 3 trial.
In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.
The estimated median event-free survival (EFS) has not yet been reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event-free at two years compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.
Concurrently, AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab was recommended for approval in the European Union for adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.
The positive opinion was based on the ECHO Phase 3 trial results.
Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.
Price Action: AZN stock is down 0.86% at $73.16 at the last check Monday.
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