Phase III NIAGARA: Molecular Subtypes and EFS Outcomes With Perioperative Durvalumab in Bladder Cancer

At #ESMO26, Matthew D. Galsky presented an exploratory molecular analysis from the Phase III NIAGARA trial (4741RO), evaluating genomic alterations and transcriptome-defined subtypes in muscle-invasive bladder cancer (MIBC).

Key findings:
▫️ Overall population: 24-month EFS was 68% with durvalumab plus neoadjuvant chemotherapy versus 60% with chemotherapy alone (HR 0.68; 95% CI 0.56–0.82).
▫️ Genomic subgroups: EFS HRs numerically favoured durvalumab in TP53-mutated (HR 0.51), FGFR3-mutated (HR 0.24), and TMB-high tumours (HR 0.44).
▫️ Molecular subtypes: EFS HRs favoured durvalumab in basal-squamous (HR 0.47; 95% CI 0.20–1.11), luminal (HR 0.52), and luminal-infiltrated (HR 0.67) subgroups, but not in the luminal-papillary subgroup (HR 1.35).

Takeaway: Exploratory findings suggest broadly favourable EFS outcomes with perioperative durvalumab across multiple molecular subgroups. These analyses were not alpha-controlled and require cautious interpretation.

@tompowles1 @ZakhariaYousef @oncodaily @myESMO

https://oncodaily.com/genitourinary-oncology/niagara-esmo-2026

#ESMO26 #ESMO2026 #NIAGARA