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Bending the Curve Trial by Trial
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NIAGARA

Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer

Phase 3N = 1,063NCT03732677

Population
Cisplatin-eligible patients with muscle-invasive bladder cancer
Design
Phase 3, open-label randomised trial (1:1) in cisplatin-eligible muscle-invasive bladder cancer: four cycles of neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks, radical cystectomy, then eight cycles of adjuvant durvalumab every 4 weeks; or four cycles of neoadjuvant gemcitabine-cisplatin then radical cystectomy alone. Event-free survival was one of two primary end points (ClinicalTrials.gov lists pathologic complete response as the other); overall survival was the key secondary end point.
Primary endpoint
EFS, pCR
Arms
  • Durvalumab plus gemcitabine-cisplatin (experimental, n = 533): Neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for four cycles, radical cystectomy, then adjuvant durvalumab every 4 weeks for eight cycles
  • Gemcitabine-cisplatin (control, n = 530): Neoadjuvant gemcitabine-cisplatin, then radical cystectomy alone
People
Powles T, senior author van der Heijden MS, NIAGARA Investigators
EFSHR 0.68 (95% CI 0.56–0.82)Δ 24-month EFS+8 pointsOSHR 0.75 (95% CI 0.59–0.93)Δ 24-month OS+7 points
Show the numbers
Results reported for NIAGARA
EndpointAnalysisDurvalumab plus gemcitabine-cisplatinGemcitabine-cisplatinEffect
EFSRandomised patients (analysis population not stated in the abstract)The abstract's hazard ratio is for progression, recurrence, not undergoing radical cystectomy, or death from any cause.primaryPowles 202467.8% at 2 y (63.6–71.7%)59.8% at 2 y (55.4–64.0%)HR 0.68 (95% CI 0.56–0.82)P<0.001 (stratified log-rank test)
OSRandomised patients (analysis population not stated in the abstract)primaryPowles 202482.2% at 2 y (78.7–85.2%)75.2% at 2 y (71.3–78.8%)HR 0.75 (95% CI 0.59–0.93)P=0.01 (stratified log-rank test)Overall survival was the key secondary end point.
Results reported for NIAGARA
EndpointAnalysisDurvalumab plus gemcitabine-cisplatinGemcitabine-cisplatinEffect
EFSRandomised patients (analysis population not stated in the abstract)The abstract's hazard ratio is for progression, recurrence, not undergoing radical cystectomy, or death from any cause.primaryPowles 202467.8% at 2 y (63.6–71.7%)59.8% at 2 y (55.4–64.0%)HR 0.68 (95% CI 0.56–0.82)P<0.001 (stratified log-rank test)
OSRandomised patients (analysis population not stated in the abstract)primaryPowles 202482.2% at 2 y (78.7–85.2%)75.2% at 2 y (71.3–78.8%)HR 0.75 (95% CI 0.59–0.93)P=0.01 (stratified log-rank test)Overall survival was the key secondary end point.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.680.56–0.82
OS0.750.59–0.93
Primary publication: Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, et al. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024;391(19):1773-1786. PubMedDOI

Appears in

Sources

  1. Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, et al. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024;391(19):1773-1786.

    PubMedDOI