OnCo
trialsTrialMixed

CheckMate 577

A year of immunotherapy after surgery doubled the time before cancer returned in patients whose tumour had not fully responded to chemoradiation, though the survival gain did not reach significance.

DFS 22.4 vs 11.0 months (HR 0.69; NEJM 2021), the basis of the 2021 FDA approval. Final OS (ASCO 2025): 51.7 vs 35.3 months, HR 0.85 (95% CI 0.70-1.04), not statistically significant; DMFS and PFS2 favoured nivolumab. Remains standard adjuvant therapy in NCCN and ESMO.

Setting
Resected oesophageal/GEJ cancer with residual disease after neoadjuvant chemoradiation: adjuvant nivolumab 1 year vs placebo
Phase
Phase 3
Sponsor
BMS
Registry
Headline result
DFS 22.4 vs 11.0 months (HR 0.69); OS 51.7 vs 35.3 months (HR 0.85, NS).
Reported
2021
Enrolled
794
Replication
Single phase 3; real-world matched cohorts show similar OS direction.

Outcomes

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In plain words
What these results mean for people, not percentages
794 people took part
Disease-free survivalprimarysurrogate endpoint
  • Median 22.4 vs 11 months with Nivolumab compared with Placebo; about 11.4 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).
  • 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 (final)survival endpoint
  • Median 51.7 vs 35.3 months with Nivolumab compared with Placebo; about 16.4 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 15 percent lower chance of the event at any given time (hazard ratio 0.85, likely range 0.7 to 1.04).
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • 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: Resected oesophageal/GEJ cancer with residual disease after neoadjuvant chemoradiation: 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.

794 participants enrolled.

Disease-free survivalprimary
HR 0.69
Nivolumab
22.4 mo
Placebo
11 mo
Source
Overall survival (final)
HR 0.85 (0.7–1.04) · p = 0.1064
Nivolumab
51.7 mo
Placebo
35.3 mo
Source
EndpointArmnValueHR (95% CI)pSource
Disease-free survivalprimaryNivolumab53222.4 months0.69link
Placebo26211 months
Overall survival (final)Nivolumab53251.7 months0.85 (0.7–1.04)0.1064link
Placebo26235.3 months
Replication
Single phase 3; real-world matched cohorts show similar OS direction.

Connected

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