NSCLC: pembrolizumab bests docetaxel for long-term survival

  • Herbst RS & al.
  • J Clin Oncol
  • 20 Feb 2020

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Pembrolizumab offers better long-term survival than docetaxel in patients with previously treated, programmed death-ligand 1 (PD-L1)-expressing advanced NSCLC.

Why this matters

  • Objective response rate (ORR) after 2 years was high, and second-course treatment after disease progression yielded good disease control.

Study design

  • Multicenter, randomized, open-label KEYNOTE-010 trial.
  • 1033 patients with previously treated PD-L1-expressing advanced NSCLC received up to 35 cycles/2 years of pembrolizumab (n=344 at 2 mg/kg and n=346 at 10 mg/kg) every 3 weeks or docetaxel 75 mg/m2 every 3 weeks (n=343).
  • Median follow-up of 42.6 months.
  • Funding: MSD.

Key results

  • Lower mortality risk with pembrolizumab vs docetaxel:
    • PD-L1 TPS ≥50%: HR, 0.53 (P<.00001>
    • PD-L1 TPS ≥1%: HR, 0.69 (P<.00001>
  • Lower risk for disease progression or death with pembrolizumab vs docetaxel:
    • PD-L1 TPS ≥50%: HR, 0.57 (P<.00001>
    • PD-L1 TPS ≥1%: HR, 0.83 (P=.005).
  • ORR among patients who completed 35 cycles was 94.9%, with ongoing response in 64.0%.
  • 14 patients received second-course pembrolizumab:
    • 5 completed 17 cycles.
    • 42.9% had partial response.
    • 35.7% had stable disease.
  • Grade 3-5 adverse events: 16.1% in pembrolizumab group vs 36.6% in docetaxel group.

Limitations

  • Patients with EGFR/ALK mutations were underrepresented.