Summary
This phase 3 randomised controlled trial evaluated maintenance avelumab (an anti-PD-L1 immunotherapy) as an addition to best supportive care in 700 patients with advanced or metastatic urothelial cancer who did not progress during first-line platinum-based chemotherapy. Avelumab significantly prolonged overall survival (median 21.4 vs 14.3 months; hazard ratio 0.69) and progression-free survival compared to supportive care alone, with greater benefit observed in the PD-L1-positive population. However, immunotherapy was associated with substantially increased adverse event burden (98.0% vs 77.7% any-grade events), with grade 3+ events in 47.4% of treated patients.
UK applicability
The findings are directly applicable to UK oncology practice, as avelumab and immune checkpoint inhibition are relevant to British cancer treatment pathways. The trial's multicentre international design, including European sites, aligns with NHS treatment populations and standards, though access and implementation would depend on current NICE appraisal and cost-effectiveness thresholds.
Key measures
Overall survival at 1 year; median overall survival; hazard ratio for death; progression-free survival; adverse event incidence and grade
Outcomes reported
The study measured overall survival and progression-free survival in patients with advanced or metastatic urothelial carcinoma receiving maintenance avelumab versus best supportive care alone after first-line platinum-based chemotherapy. Secondary outcomes included safety and adverse event incidence.
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