FDA approves durvalumab for perioperative immunotherapy for patients with muscle-invasive bladder cancer
Cette étude analyse les données de l'essai ayant conduit la "Food and Drug Administration" à autoriser l'utilisation du durvalumab en traitement périopératoire chez des patients atteints d'un cancer de la vessie avec envahissement musculaire
The US Food and Drug Administration has approved the first perioperative immunotherapy (durvalumab) for patients with muscle-invasive bladder cancer. The approval is for a regimen of neoadjuvant durvalumab combined with gemcitabine or cisplatin (every 3 weeks for four cycles) before radical cystectomy followed by single-agent adjuvant durvalumab (every 4 weeks for eight cycles).1, 2
Before this approval, the standard of care for patients with muscle-invasive bladder cancer was neoadjuvant chemotherapy followed by radical cystectomy for cisplatin-eligible patients.
The approval is based on the results of the phase 3 NIAGARA trial, an open-label trial that included 1063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. The patients were randomized to neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery (n = 533) or neoadjuvant chemotherapy followed by surgery alone (n = 530).3
In a prespecified planned interim analysis, significant improvement was seen in both the main outcome, event-free survival (EFS), and the secondary outcome, overall survival (OS), in the durvalumab-treated group. At 24 months, the estimated EFS rate was significantly greater in the durvalumab-treated group (67.8%) than the chemotherapy/surgery–alone group (59.8%); this represented a 32% reduction in the risk of disease progression, recurrence, not undergoing radical cystectomy, or death from any cause (hazard ratio [HR], 0.68; 95% CI, 0.56–0.82; p < .001). The median EFS was 46.1 months in the chemotherapy/surgery–alone group and was not reached in the durvalumab-treated group.1-3
OS at 24 months also was significantly greater in the durvalumab-treated group versus the chemotherapy/surgery–alone group (82.2% vs. 75.2%; HR, 0.75; 95% CI, 0.59–0.93; p = .01). Neither arm had reached median survival at the time of the analysis. (...)
Cancer , article en libre accès, 2025