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ANVIL (ALCHEMIST EA5142) — Adjuvant nivolumab after surgery + chemo, resected EGFR/ALK-wild-type NSCLC, adjuvant

Abstract: 8000 · Session: Lung Cancer — Non-Small Cell oral abstract session, ASCO Annual Meeting (May 29 – Jun 2, 2026, Chicago) · Presenter: Jamie E. Chaft, MD (Memorial Sloan Kettering Cancer Center / ECOG-ACRIN) · Embargo: per ASCO; results simultaneously published in JAMA

At a glance

  • Sponsor: ECOG-ACRIN Cancer Research Group / National Cancer Institute (NCI); nivolumab supplied by Bristol Myers Squibb
  • PI / presenter: Jamie E. Chaft, MD (Memorial Sloan Kettering Cancer Center)
  • NCT ID: NCT02595944
  • Phase: 3
  • Design: Randomized, open-label; nivolumab vs observation/best supportive care after complete surgical resection and standard adjuvant chemotherapy (and radiation when indicated). Part of the ALCHEMIST platform.
  • N: 935 (nivolumab n=466; observation n=469)
  • Primary endpoint(s): Disease-free survival (DFS) in the ITT and PD-L1–high (TPS ≥50%) populations
  • Comparator: Observation / best supportive care
  • Indication: Resected stage IB–IIIA NSCLC, EGFR- and ALK-wild-type
  • Line: Adjuvant (post-surgery, post-chemotherapy)

Headline result

Adjuvant nivolumab did not improve disease-free survival versus observation. In the ITT population, median DFS was 71.3 months with nivolumab vs 68.8 months with observation (HR 0.97; 95% CI 0.81–1.17; P=.39). The PD-L1–high (TPS ≥50%) subgroup also showed no significant benefit: median DFS 89.9 vs 78.5 months (HR 0.86; 95% CI 0.59–1.25; P=.43). Because the primary DFS endpoint was not met, overall survival was not formally tested under the hierarchical plan; exploratory OS was numerically neutral in ITT (HR 1.02; 95% CI 0.82–1.26) and the PD-L1–high subset (HR 0.82; 95% CI 0.53–1.28). Median follow-up was ~72.6 months. This is the largest US cooperative-group trial of adjuvant immunotherapy in NSCLC, and the result was negative.

Mechanism / class

Nivolumab is an anti–PD-1 monoclonal antibody (immune checkpoint inhibitor). It is approved across multiple NSCLC settings, including perioperative/neoadjuvant use (e.g., neoadjuvant nivolumab + chemotherapy, CheckMate 816). EA5142/ANVIL tested the purely adjuvant, post-chemotherapy monotherapy strategy.

Practice-changing?

No. The trial is negative for its primary DFS endpoint in both the ITT and PD-L1–high populations, and exploratory OS showed no benefit. The result argues against adjuvant single-agent nivolumab administered after completion of standard adjuvant chemotherapy, and contrasts with positive perioperative/neoadjuvant chemo-immunotherapy regimens and with adjuvant atezolizumab (IMpower010) and pembrolizumab (PEARLS/KEYNOTE-091) data, reinforcing questions about sequencing and the value of adjuvant-only checkpoint monotherapy.

  • Other ASCO 2026 trials: see ../index.md for same-class/indication lung trials
  • AACR 2026: ../../aacr-2026/index.md

Sources

  • ASCO Meeting Library (abstract 8000 / poster record): https://www.asco.org/posters/POSTER189784
  • CancerNetwork: https://www.cancernetwork.com/view/post-surgery-nivolumab-shows-no-dfs-improvement-in-egfr-alk-negative-nsclc
  • OncUpdates ASCO 2026 lung preview: https://oncupdates.com/article/what-to-watch-at-asco-2026-a-thoracic-oncologists-guide-to-the-lung-cancer-program/
  • ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT02595944