JAVELIN Bladder 100
Starting immunotherapy right after chemotherapy, rather than waiting for relapse, lengthened survival by about seven months.
OS 21.4 vs 14.3 months (HR 0.69). Made avelumab maintenance the standard after platinum for four years, until EV-302 displaced platinum from first line for most patients. Still relevant where EV + pembrolizumab is unavailable or contraindicated.
Setting
Advanced urothelial cancer without progression after 4-6 cycles of platinum chemotherapy: avelumab maintenance + best supportive care vs BSC
Phase
Phase 3
Sponsor
Merck KGaA / Pfizer
Registry
Headline result
OS 21.4 vs 14.3 months, HR 0.69.
Reported
2020
Enrolled
700
Replication
Consistent with real-world maintenance series; superseded rather than contradicted by EV-302.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 21.4 vs 14.3 months with Avelumab + BSC compared with BSC; about 7.1 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.56 to 0.86).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Advanced urothelial cancer without progression after 4-6 cycles of platinum chemotherapy: avelumab maintenance + best supportive care vs BSC. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
700 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Avelumab + BSC | 350 | 21.4 months | 0.69 (0.56–0.86) | 0.001 | link |
| BSC | 350 | 14.3 months |
Replication
Consistent with real-world maintenance series; superseded rather than contradicted by EV-302.