CheckMate 274
A year of nivolumab after bladder or upper-tract surgery reduces recurrence and, with long follow-up, extends life.
DFS HR 0.70 (ITT); OS HR 0.83 (ITT; 0.70 in MIBC subset) with median OS 75 vs 50.1 months; 5-year data confirm durability. FDA approval August 2021. Competes with perioperative approaches (NIAGARA, EV-303/304) and with ctDNA-guided adjuvant atezolizumab (IMvigor011).
Setting
High-risk muscle-invasive urothelial carcinoma after radical surgery: adjuvant nivolumab 1 year vs placebo
Phase
Phase 3
Sponsor
BMS
Registry
Headline result
DFS HR 0.70; OS HR 0.83 (ITT), median 75 vs 50.1 months.
Reported
2021
Enrolled
709
Replication
IMvigor010 (adjuvant atezolizumab, all-comers) was negative, but its ctDNA-positive subgroup led to IMvigor011, which was positive; AMBASSADOR (adjuvant pembrolizumab) improved DFS.
In plain words
What these results mean for people, not percentages
Disease-free survivalprimarysurrogate endpoint
- Median 22 vs 10.9 months with Nivolumab compared with Placebo; about 11.1 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 30 percent lower chance of the event at any given time (hazard ratio 0.7, likely range 0.57 to 0.85).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survival (ITT)survival endpoint
- Median 75 vs 50.1 months with Nivolumab compared with Placebo; about 24.9 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 17 percent lower chance of the event at any given time (hazard ratio 0.83).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: High-risk muscle-invasive urothelial carcinoma after radical surgery: adjuvant nivolumab 1 year vs placebo. 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.
709 participants enrolled.
Overall survival (ITT)
HR 0.83
Nivolumab
75 mo
Placebo
50.1 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survivalprimary | Nivolumab | 353 | 22 months | 0.7 (0.57–0.85) | — | link |
| Placebo | 356 | 10.9 months | ||||
| Overall survival (ITT) | Nivolumab | — | 75 months | 0.83 | — | — |
| Placebo | — | 50.1 months |
Replication
IMvigor010 (adjuvant atezolizumab, all-comers) was negative, but its ctDNA-positive subgroup led to IMvigor011, which was positive; AMBASSADOR (adjuvant pembrolizumab) improved DFS.Pages like this
not linked directly; found by shared links- PersonMatthew D. Galsky
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