CheckMate 577
After neoadjuvant chemoradiotherapy and R0 resection with residual pathological disease, does adjuvant nivolumab improve DFS?
Trial design and population
Key results
Median DFS was 22.4 months with nivolumab vs 11.0 months with placebo (HR 0.69, 96.4% CI 0.56–0.86; P=.0003). Benefit was seen in squamous and adenocarcinoma subgroups. OS benefit was not established in the primary report.
Source-reported outcome visualization
Median disease-free survival · Median
Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.
Absolute Effect
Median DFS difference 11.4 months is not an NNT. DFS benefit is demonstrated; do not infer OS benefit from this endpoint.
NNT: Not calculated; median DFS difference is not a valid NNT. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.
NNH: Not quantifiable. Grade 3–4 treatment-related AEs occurred in about 13% with nivolumab vs 6% with placebo. Immune-mediated pneumonitis, colitis, hepatitis and endocrinopathies may require prolonged treatment; discontinuation due to treatment-related events was higher with nivolumab.
Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.
Safety and treatment burden
Grade 3–4 treatment-related AEs occurred in about 13% with nivolumab vs 6% with placebo. Immune-mediated pneumonitis, colitis, hepatitis and endocrinopathies may require prolonged treatment; discontinuation due to treatment-related events was higher with nivolumab.
Follow-up, maturity and limitations
Follow-up: Primary analysis median follow-up 24.4 months.
Applies to residual disease after neoadjuvant CRT and R0 resection, not pathological complete response or patients without neoadjuvant CRT. DFS was the demonstrated endpoint in the primary publication.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.