Nivolumab continues to best docetaxel at 5 years for relapsed NSCLC

  • Borghaei H & al.
  • J Clin Oncol
  • 15 Jan 2021

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Nivolumab continues to yield clinically meaningful OS, PFS, and duration of response (DOR) rates compared with docetaxel at 5 years in patients with previously treated advanced NSCLC.

Why this matters

  • This is the longest follow-up to date for randomized phase 3 trials of programmed-death 1 (PD-1) inhibitors in previously treated advanced NSCLC.

Study design

  • International, randomized, phase 3 CheckMate 017 and CheckMate 057 trials (minimum follow-up of 64.2 months and 64.5 months, respectively).
  • 854 patients with advanced previously treated NSCLC received nivolumab (n=427) or docetaxel (n=427).
  • Funding: Bristol Myers Squibb.

Key results

  • 5-year pooled OS was significantly better with nivolumab compared with docetaxel:
    • 13.4% vs 2.6%.
    • HR: 0.68 (95% CI, 0.59-0.78).
  • OS improvement with nivolumab persisted regardless of squamous or nonsquamous histology or tumor PD-1 expression.
  • 5-year pooled PFS was better with nivolumab:
    • 8.0% vs 0% docetaxel.
    • HR: 0.79 (95% CI, 0.68-0.92).
  • Nivolumab offered a better pooled objective response rate (19.7% vs 11.2%) and median DOR (19.9 months vs 5.6 months).
  • No new safety signals for nivolumab at 5 years.

Limitations

  • Open-label trial.