NSCLC: pembrolizumab tops chemotherapy at lower PD-L1 cutoff

  • Mok TSK & al.
  • Lancet
  • 4 Apr 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Pembrolizumab monotherapy yielded a survival advantage with lower toxicity than standard chemotherapy in patients with previously untreated locally advanced or metastatic NSCLC and a programmed death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
  • Pembrolizumab efficacy rose with TPS score.

Why this matters

Study design

  • International, randomized, phase 3 KEYNOTE-042 trial.
  • 1274 patients with locally advanced or metastatic NSCLC and a PD-L1 TPS of ≥1% received first-line therapy with pembrolizumab monotherapy (n=637) or platinum-based chemotherapy (n=637).
  • Funding: MSD.

Key results

  • Pembrolizumab yielded significantly better OS than chemotherapy (TPS ≥50%: HR, 0.69 [P=.0003]; TPS ≥20%: HR, 0.77 [P=.0020]; and TPS ≥1%: HR, 0.81 [P=.0018]).
  • Median OS was longer with pembrolizumab vs chemotherapy (TPS ≥50%: 20 vs 12.2 months; TPS ≥20%: 17.7 vs 13.0 months; TPS ≥1%: 16.7 vs 12.1 months).
  • Fewer any-grade treatment-related adverse events (63% vs 90%) and fewer grade ≥3 toxicities (18% vs 41%) with pembrolizumab.

Limitations

  • Open-label design.

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