Five-year clinical outcomes after neoadjuvant nivolumab in resectable non-small cell lung cancer Journal Article


Authors: Rosner, S.; Reuss, J. E.; Zahurak, M.; Zhang, J.; Zeng, Z.; Taube, J.; Anagnostou, V.; Smith, K. N.; Riemer, J.; Illei, P. B.; Broderick, S. R.; Jones, D. R.; Topalian, S. L.; Pardoll, D. M.; Brahmer, J. R.; Chaft, J. E.; Forde, P. M.
Article Title: Five-year clinical outcomes after neoadjuvant nivolumab in resectable non-small cell lung cancer
Abstract: 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. ©2023 The Authors; Published by the American Association for Cancer Research.
Keywords: neoadjuvant therapy; carcinoma, non-small-cell lung; lung neoplasms; lung tumor; programmed death 1 ligand 1; non small cell lung cancer; nivolumab; humans; human; b7-h1 antigen
Journal Title: Clinical Cancer Research
Volume: 29
Issue: 4
ISSN: 1078-0432
Publisher: American Association for Cancer Research  
Date Published: 2023-02-15
Start Page: 705
End Page: 710
Language: English
DOI: 10.1158/1078-0432.Ccr-22-2994
PUBMED: 36794455
PROVIDER: scopus
PMCID: PMC9932577
DOI/URL:
Notes: Article -- MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in PDF -- Export Date: 1 March 2023 -- Source: Scopus
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  1. Jamie Erin Chaft
    289 Chaft
  2. David Randolph Jones
    417 Jones