Bladder Cancer · Medical · Metastatic / First-line maintenance

JAVELIN Bladder 100

After non-progression on first-line platinum chemotherapy for advanced urothelial carcinoma, does maintenance avelumab improve overall survival?

Population700 patients randomized to avelumab plus best supportive care or best supportive care alone after response or stable disease on platinum chemotherapy.InterventionAvelumab maintenance.ComparatorBest supportive care alone.Primary endpointOverall survival in the overall population and PD-L1-positive population.

Absolute Effect

1-year overall survival

71.3% vs 58.4% (+12.9 points)

HR for death 0.69 (95% CI 0.56–0.86), P=.001. Median OS 21.4 vs 14.3 months.

Progression-free survival

3.7 vs 2.0 months

HR 0.62 for progression or death.

Toxicity

Grade ≥3 adverse events occurred in 47.4% with avelumab versus 25.2% with control. Any adverse events occurred in 98.0% vs 77.7%.

Clinical interpretation

Maintenance avelumab produced a clinically large early absolute survival benefit in patients whose disease had not progressed after platinum chemotherapy.

The key eligibility concept is disease control after first-line chemotherapy; this is not an unselected first-line immunotherapy comparison.

NNT / NNH

Using the 1-year OS difference, NNT ≈ 8. For grade ≥3 adverse events, the absolute excess was 22.2 percentage points, corresponding to an approximate NNH of 5 for this broad toxicity endpoint.

Limitations

The control arm was best supportive care rather than active second-line therapy, and only patients who completed first-line chemotherapy without progression entered the maintenance randomization.

Primary / authoritative sources

JAVELIN Bladder 100 primary report — PubMed