Background
Phase III CCTG BR.31 trial, N=1,367, of adjuvant durvalumab vs placebo in resected stage IB–IIIA NSCLC, EGFR/ALK wild-type, after standard adjuvant chemotherapy.
Interventions and follow up
Arm A: Durvalumab 1500 mg IV Q4W for 1 yr (up to 12 doses)
Arm B: Placebo IV Q4W for 1 yr
Primary endpoint: Disease-free survival (DFS) in PD-L1 ≥25% population, and overall
mFollow up: 60 mo
Arm B: Placebo IV Q4W for 1 yr
Primary endpoint: Disease-free survival (DFS) in PD-L1 ≥25% population, and overall
mFollow up: 60 mo
Results
DFS (PD-L1 ≥25%): median 70.1 vs 60.8 mo, HR 0.92, P=.53
DFS (all patients): median ~60 mo both arms, HR ~0.99
OS: No improvement; 5-yr OS ~75% both arms (immature)
DFS (all patients): median ~60 mo both arms, HR ~0.99
OS: No improvement; 5-yr OS ~75% both arms (immature)
Adverse events
Overall: Grade ≥3 AE ~15% (durvalumab) vs ~9% (placebo)
Discontinuation: 16% for toxicity with durvalumab vs 3% placebo
Immune-related: Pneumonitis ~1%; no new safety signals
Discontinuation: 16% for toxicity with durvalumab vs 3% placebo
Immune-related: Pneumonitis ~1%; no new safety signals
Conclusions
Adjuvant durvalumab did not significantly prolong DFS or OS in resected NSCLC. BR.31 is a negative trial, indicating adjuvant PD-L1 inhibition after chemotherapy provides no clear benefit in unselected or PD-L1–high patients.
Key Limitations
Single-agent adjuvant design without neoadjuvant component; OS immature; biomarker-defined benefit not identified; contrasts with positive perioperative regimens.
Clinical Context
Atezolizumab (IMpower010) and pembrolizumab (KEYNOTE-091/PEARLS) are approved adjuvant options in resected NSCLC; BR.31 does not support adjuvant durvalumab monotherapy in this setting per ASCO/ESMO.