Five-Year Clinical Outcomes after Neoadjuvant Nivolumab in Resectable Non-Small Cell Lung Cancer

Samuel Rosner, Joshua E. Reuss, Marianna Zahurak, Jiajia Zhang, Zhen Zeng, Janis Taube, Valsamo Anagnostou, Kellie Smith, Joanne Riemer, Peter B Illei, Stephen R. Broderick, David R. Jones, Suzanne L. Topalian, Drew M. Pardoll, Julie R. Brahmer, Jamie E. Chaft, Patrick M. Forde

Research output: Contribution to journalArticlepeer-review


PURPOSE: Neoadjuvant anti-PD-1 therapy has shown promise for resectable non-small cell lung cancer (NSCLC). We reported the first phase I/II trial of neoadjuvant nivolumab in resectable NSCLC, finding it to be safe and feasible with encouraging major pathological responses (MPR). We now present 5-year clinical outcomes from this trial, representing to our knowledge, the longest follow-up data for neoadjuvant anti-PD-1 in any cancer type. PATIENTS AND METHODS: Two doses of nivolumab (3 mg/kg) were administered for 4 weeks before surgery to 21 patients with Stage I-IIIA NSCLC. 5-year recurrence-free survival (RFS), overall survival (OS), and associations with MPR and PD-L1, were evaluated. RESULTS: With a median follow-up of 63 months, 5-year RFS and OS rates were 60% and 80%, respectively. The presence of MPR and pre-treatment tumor PD-L1 positivity (TPS ≥1%) each trended toward favorable RFS; HR, 0.61 [95% confidence interval (CI), 0.15-2.44] and HR, 0.36 (95% CI, 0.07-1.85), respectively. At 5-year follow-up, 8 of 9 (89%) patients with MPR were alive and disease-free. There were no cancer-related deaths among patients with MPR. In contrast, 6/11 patients without MPR experienced tumor relapse, and 3 died. CONCLUSIONS: Five-year clinical outcomes for neoadjuvant nivolumab in resectable NSCLC compare favorably with historical outcomes. MPR and PD-L1 positivity trended toward improved RFS, though definitive conclusions are limited by cohort size.

Original languageEnglish (US)
Pages (from-to)705-710
Number of pages6
JournalClinical cancer research : an official journal of the American Association for Cancer Research
Issue number4
StatePublished - Feb 16 2023

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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