EA5142 trial: Nivolumab shows no DFS benefit in NSCLC

By Laura Boyd

Adjuvant nivolumab did not improve disease-free survival (DFS) compared with observation in patients with resected, EGFR/ALK-negative non–small-cell lung cancer (NSCLC) following surgery and adjuvant chemotherapy, according to results from the phase 3 EA5142 (ALCHEMIST) trial (NCT02595944) presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

At a median follow-up of 72.6 months, DFS outcomes were similar between treatment arms. In the intention-to-treat population, median DFS was 71.3 months with nivolumab versus 68.8 months with observation (hazard ratio [HR], 0.97), with no statistically significant difference observed.

No clinically meaningful benefit was observed in biomarker-selected patients. In patients with tumor PD-L1 expression ≥50%, median DFS was 89.8 months with nivolumab compared with 78.5 months with observation (HR, 0.86).

Jamie E. Chaft (Memorial Sloan Kettering Cancer Center, New York, USA) presented the data, stating that adjuvant nivolumab after upfront resection and planned adjuvant therapy “does not improve outcomes” in this population.

Sensitivity analyses excluding new primary lung cancers produced consistent findings, and exploratory overall survival results also showed no meaningful difference between treatment arms in the intention-to-treat population (HR approximately 1.02).

The EA5142 trial enrolled 935 patients with completely resected stage 1B (tumors ≥4 cm) to 3A NSCLC without sensitizing EGFR or ALK alterations across 377 US sites. Patients were randomized to receive nivolumab 480 mg every 4 weeks for up to 1 year or observation following completion of adjuvant chemotherapy with or without radiotherapy. Stratification factors included stage, histology, prior adjuvant treatment, and PD-L1 expression.

The median duration of nivolumab treatment was 9.4 months, and safety was consistent with the known profile of nivolumab. Treatment-related grade 3–5 adverse events occurred in 25% of patients and included pneumonitis, dyspnea, diarrhea, and fatigue. Discontinuation was most commonly due to:

• Adverse events (29%)
• Patient withdrawal (11%)
• Disease progression (10%)

Chaft concluded that the results “do not change the current standard,” while the role of adjuvant immunotherapy after upfront surgery remains uncertain.

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