Background
Phase 3, randomised, open-label trial (EA5142/ANVIL, ALCHEMIST platform); N=935 (466 nivolumab, 469 observation); 378 US NCTN centers, enrolled 2016–2019. Resected NSCLC ≥4 cm and/or node-positive (N1/N2); adenocarcinoma without sensitizing EGFR/ALK alterations or squamous histology; enrolled after completion of planned standard adjuvant chemotherapy ± RT. Nivolumab = anti-PD-1.
Results
Interventions and follow up: Arm A: Nivolumab 480 mg IV q4w for up to 1 year
Arm B: Standard-care observation
Primary endpoint: Co-primary — DFS in ITT and in PD-L1 ≥50%
mFollow up: 72.6 mo
Results: Trial stopped for futility at 75% information.
DFS (ITT): 71.3 vs 68.8 mo; HR 0.97 (95% CI 0.81–1.17); 1-sided P=.39 — not met
DFS (PD-L1 ≥50%): 89.8 vs 78.5 mo; HR 0.86 (95% CI 0.59–1.25); 1-sided P=.22 — not met
OS: not formally tested (hierarchical gate not passed); NR
Arm B: Standard-care observation
Primary endpoint: Co-primary — DFS in ITT and in PD-L1 ≥50%
mFollow up: 72.6 mo
Results: Trial stopped for futility at 75% information.
DFS (ITT): 71.3 vs 68.8 mo; HR 0.97 (95% CI 0.81–1.17); 1-sided P=.39 — not met
DFS (PD-L1 ≥50%): 89.8 vs 78.5 mo; HR 0.86 (95% CI 0.59–1.25); 1-sided P=.22 — not met
OS: not formally tested (hierarchical gate not passed); NR
Adverse events
Safety: NR in abstract
Conclusions
Adjuvant nivolumab after upfront surgery and planned adjuvant chemotherapy/RT did not improve DFS overall or in PD-L1 ≥50% resected NSCLC. A definitive negative result for the adjuvant-only anti-PD-1 monotherapy strategy in this setting.
Key Limitations
Stopped for futility at 75% information; PD-L1 ≥50% subset underpowered (wide CIs). Enrolled 2016–2019, before adjuvant osimertinib/atezolizumab/pembrolizumab and neoadjuvant/perioperative chemo-IO became standard, limiting applicability to current practice. Open-label; OS not formally evaluable.
Clinical Context
Contrasts with IMpower010 (adjuvant atezolizumab: DFS benefit, PD-L1 ≥1% stage II–IIIA) and KEYNOTE-091 (adjuvant pembrolizumab). Together with CheckMate 816/77T, KEYNOTE-671 and AEGEAN, reinforces the shift toward neoadjuvant/perioperative checkpoint inhibition rather than adjuvant-only IO. Nivolumab is not approved as adjuvant monotherapy in NSCLC.