Efficacy
The median follow-up was 20.9 months in the nivolumab group versus 19.5 months in the placebo group.r
Summary of resultsr
Outcome |
ITT population |
PD-L1≥1% population |
|
Nivolumab |
Placebo |
Nivolumab |
Placebo |
Median DFS, months (95% CI) |
20.8 (16.5-27.6) |
10.8 (8.3-13.9) |
- |
- |
6-month DFS rate, % |
74.9 |
60.3 |
74.5 |
55.7 |
HR=0.70, 98.22% CI 0.55-0.90, p<0.001 |
HR=0.55, 98.72% CI 0.35-0.85, p<0.001) |
Median RFS, months (95% CI)* |
22.9 (19.2-33.4) |
13.7 (8.4-20.3) |
- |
- |
6-month RFS rate, %** |
77.0 |
62.7 |
75.3 |
56.7 |
HR=0.72, 95% CI 0.59-0.89 |
p=0.55; 95% CI 0.39-0.79 |
Distant MFS, months (95% CI)# |
40.5 (22.4-NE) |
29.5 (16.7-NE) |
- |
- |
6-month distant MFS rate, % |
82.5 |
69.8 |
78.7 |
65.7 |
HR=0.75, 95% CI 0.59-0.94 |
HR=0.61, 95% CI 0.42-0.90 |
* Median survival free from recurrence outside the urothelial tract, ** The percentage of patients who were alive and free from recurrence outside the urothelial tract at 6 months, # Distant metastasis–free survival, NE: Not estimated
The subgroup analysis results demonstrated higher DFS probability benefits with nivolumab as compared with placebo; regardless of nodal status, PD-L1 status, or previous treatment with neoadjuvant cisplatin-based chemotherapy.
Kaplan-Meier curves of DFS in (A) ITT (B) PD-L1≥1% populationsr
© N Engl J Med 2021
Kaplan-Meier curves of RFS outside the urothelial tract in (A) ITT (B) PD-L1≥1% populationsr
© N Engl J Med 2021
Forest plot of hazard ratios for disease recurrence or death amongst prespecified subgroups of ITT populationr
© N Engl J Med 2021
Quality of life data was completed by ≥85% of patients during the treatment period, and ≥75% in the follow-up period. There was no meaningful difference in deterioration of quality of life between the two treatment groups in both ITT and PD-L1≥1% populations.