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Adjuvant Nivolumab Plus Chemo Cuts Early Relapse in Resected NSCLC, Interim Phase III Data Show

Investigators call the first analysis immature at 57% data maturity, signaling the need for longer follow-up.

Overview

  • At the first interim analysis of the randomized Phase III NADIM ADJUVANT trial, relapse occurred in 20.4% of patients on chemo‑immunotherapy vs 38.8% on chemotherapy alone after complete resection of stage IB–IIIA NSCLC.
  • The 3‑year disease‑free survival hazard ratio was 0.65 (95% CI, 0.40–1.07; P = .085), and median DFS was not reached in either arm after about 34 months of follow‑up.
  • Pre‑specified sensitivity and landmark analyses showed statistically significant advantages for the experimental regimen, including cancer‑specific DFS (HR, 0.54; P = .025) and a 90‑day post‑surgery landmark DFS analysis (HR, 0.60; P = .048).
  • Grade ≥3 treatment‑related adverse events were more frequent with nivolumab plus chemotherapy during the adjuvant phase (26.2% vs 14.5%).
  • Postoperative ctDNA‑based minimal residual disease (Guardant Reveal) identified markedly higher recurrence risk in the experimental arm when positive (HR, 5.7; P = .045).