Adjuvant nivolumab does not extend disease-free survival after lung cancer surgery in NCI trial

The 935-patient ANVIL trial, published in JAMA, found no disease-free survival benefit from a year of nivolumab after resection of non-small cell lung cancer.

A year of the immunotherapy nivolumab (Opdivo) given after lung cancer surgery did not lengthen the time patients lived free of recurrence, according to the federally sponsored ANVIL trial published in JAMA. The negative result stands apart from a string of positive adjuvant immunotherapy studies and tempers expectations for checkpoint blockade in earlier-stage disease.

ANVIL (NCT02595944), sponsored by the National Cancer Institute, was a randomized phase 3 study run at 378 sites in the US National Clinical Trials Network. Between May 2016 and September 2019 it enrolled patients with resected stage IB (at least 4 cm), II, or IIIA non-small cell lung cancer without sensitizing EGFR or ALK alterations, all of whom had completed planned adjuvant chemotherapy and/or radiotherapy. In total, 935 patients were randomized: 466 to nivolumab (480 mg intravenously every 4 weeks for up to one year) and 469 to observation.

No benefit on the co-primary endpoint

Disease-free survival, a co-primary endpoint alongside overall survival, showed no advantage. Median disease-free survival was 71.3 months with nivolumab versus 68.8 months with observation (hazard ratio for progression or death, 0.97; 97% CI, 0.79-1.20; 1-sided P = .39). In the prespecified subgroup with PD-L1 expression of 50% or higher, the hazard ratio was 0.86 (98% CI, 0.55-1.34; P = .22), also not significant.

“Adjuvant nivolumab was not associated with improved disease-free survival,” the authors concluded.

Because overall survival was to be tested only if disease-free survival was positive, it was not formally analyzed; an exploratory look showed a hazard ratio of 1.02 (95% CI, 0.82-1.26) in the overall population after a median follow-up of 72.6 months. Grade 3 to 5 treatment-related toxicities occurred in 116 nivolumab patients (25%), including two fatal respiratory events.

The result contrasts with adjuvant immunotherapy regimens that have won approval, and the authors note that nivolumab here was given after, rather than concurrent with, chemotherapy. The wide confidence interval crossing 1.0 leaves little room for a hidden benefit. Association is not causation, and these data do not constitute medical advice.

Trials Today

Phase 3 VECTRA-01 (AZD2265 / 225Ac-PSMA-I&T, mCRPC) — Recruiting; alpha-emitter PSMA radioligand vs SOC after prior beta-emitter, taxane and ARPI; ~670 patients; dual primary rPFS and OS.

Phase 3 PRECISE-HD (pridopidine, Huntington's disease) — Newly registered; 400 patients not on antidopaminergics; primary is 52-week change in composite cUHDRS.

Phase 3 QUILT-2.023 (nogapendekin alfa inbakicept, 1L NSCLC) — Terminated; sponsor registry note states no active subjects, no efficacy results posted (enrolled 102).

Phase 3 Atezolizumab + standard HER2 therapy, 1L HER2+ mBC (NRG/NCI) — Terminated for poor accrual (190 enrolled); posted PFS 52.3% vs 40.5% is a numerical, underpowered signal only (CIs overlap, no HR).

Phase 2/3 Peri-operative nivolumab + ipilimumab, esophageal/GEJ adenocarcinoma (NCI) — Suspended after enrolling 278; registry summary gives no reason, so cause is unconfirmed. Watch item.

At the Agencies

Baxdrostat (Baxfendy), AstraZeneca — FDA approval May 18, 2026; first-in-class aldosterone synthase inhibitor for uncontrolled/resistant hypertension; BaxHTN placebo-adjusted SBP -9.8 mmHg.

Bulevirtide (Hepcludex), Gilead — FDA accelerated approval May 22, 2026; first US therapy for chronic hepatitis delta; surrogate week-48 combined response 48% vs 2%, confirmatory data required.

Pivekimab sunirine (Decnupaz), AbbVie — FDA approval May 27, 2026; first CD123-directed ADC for ultra-rare BPDCN; single-arm CADENZA CR/CRc 69.7% in treatment-naive (n=33).

Nerandomilast (Jascayd), Boehringer Ingelheim — EMA CHMP — Positive CHMP opinion (18-21 May 2026) for IPF and PPF; oral PDE4B inhibitor; FIBRONEER-IPF met primary FVC endpoint, key secondary not met. EC decision pending.