NSCLC: frontline nivolumab+ipilimumab tops chemo for survival

  • Hellmann MD & al.
  • N Engl J Med
  • 28 Sep 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Patients with advanced NSCLC had significantly longer OS with first-line nivolumab+ipilimumab than chemotherapy, regardless of PD-L1 expression levels.

Why this matters

  • Prior studies had found an OS benefit from nivolumab+ipilimumab in melanoma and renal cell carcinoma, but efficacy in NSCLC was unclear.

Study design

  • Preliminary report from the randomized, phase 3 CheckMate 227 trial.
  • Patients with advanced NSCLC and PD-L1 expression levels of ≥1% or
  • Funding: Bristol-Myers Squibb; Ono Pharmaceutical.

Key results

  • In the overall population, median OS was higher with nivolumab+ipilimumab vs chemotherapy (17.1 vs 13.9 months).
  • Combination therapy offered better median OS than chemotherapy in patients with:
    • PD-L1 ≥1%: 17.1 vs 14.9 months (P=.007); HRdeath=0.62 (95% CI, 0.48-0.78).
    • PD-L1 progression/death, 0.73, P=.0007).
  • At 2 years, nivolumab+ipilimumab offered better median duration of response (17.1 vs 13.9 months) and OS (40.1% vs 29.7%) vs chemotherapy in all patients, regardless of PD-L1 expression.
  • Serious any-grade adverse events were more common with combination immunotherapy (24.5% vs 13.9%), as were events leading to discontinuation (18.1% vs 9.1%).

Limitations

  • Open-label trial.

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