Advanced NSCLC: pembrolizumab boosts long-term OS in previously treated patients

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

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • Pembrolizumab demonstrates significant long-term survival benefit over docetaxel in previously treated patients with programmed death-ligand 1 (PD-L1)-expressing, advanced NSCLC.

Why this matters

  • Previous trials have shown improved OS with pembrolizumab monotherapy vs standard chemotherapy in patients with PD-L1-expressing advanced NSCLC in all treatment lines.

Study design

  • KEYNOTE-010: 1033 patients were randomly assigned to pembrolizumab 2 mg/kg (n=344), 10 mg/kg (n=346), or docetaxel 75 mg/m2 every 3 weeks (n=343).
  • Pembrolizumab was continued for 35 cycles/2 years.
  • Patients could be treated with 17 more cycles if there was disease progression. 
  • Funding: Merck Sharp & Dohme.

Key results

  • At 42.6 months, pembrolizumab vs docetaxel reduced mortality risk:
    • PD-L1 50%: HR, 0.53 (P<.00001>
    • PD-L1 1%: HR, 0.69 (P<.00001>
  • 36-month OS for pembrolizumab vs docetaxel:
    • PD-L1 50%: 34.5% vs 12.7%.
    • PD-L1 1%: 22.9% vs 11.0%.
  • Among patients who completed 35 cycles of pembrolizumab (n=79):
    • Objective response rate: 94.9%. 
    • 12-month OS: 98.7%.
    • 24-month OS: 86.3%.
  • Grade 3-5 treatment-related adverse events occurred in 16.1% receiving pembrolizumab and 36.6% receiving docetaxel.
  • Among patients treated again with pembrolizumab, 43% had partial response and 36% had stable disease.

Limitations

  • Relatively few patients completed 35 cycles of pembrolizumab.
  • Patients with EGFR/ALK alteration were underrepresented.