JAVELIN Bladder 100: avelumab maintenance after first-line platinum chemotherapy in advanced urothelial cancer
Continuing with the immunotherapy avelumab after chemotherapy had controlled advanced bladder cancer lengthened survival by about seven months compared with watching and waiting.
Overview
Phase 3 trial of 700 patients with unresectable locally advanced or metastatic urothelial carcinoma whose disease had not progressed on four to six cycles of platinum-based chemotherapy, randomised to avelumab maintenance plus best supportive care or supportive care alone.
Median overall survival was 21.4 months with avelumab against 14.3 months with supportive care (hazard ratio 0.69). The benefit was seen regardless of PD-L1 status and established switch maintenance immunotherapy as the standard after first-line chemotherapy until enfortumab vedotin plus pembrolizumab displaced chemotherapy in the first line.
- Median overall survival 21.4 vs 14.3 months; hazard ratio for death 0.69.
- Benefit in the PD-L1-positive population (hazard ratio 0.56) and in the overall population.
For patients who still receive platinum chemotherapy first, avelumab maintenance rather than observation is the standard next step. Where enfortumab vedotin plus pembrolizumab is available first line, this sequence is used less.
- Open-label design.
- The comparator did not include immunotherapy at progression for all patients, which may exaggerate the gain compared with sequential use.
Similar pages
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