- 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.
- 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.
- 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>
- PD-L1 ≥50%: 34.5% vs 12.7%.
- PD-L1 ≥1%: 22.9% vs 11.0%.
- Objective response rate: 94.9%.
- 12-month OS: 98.7%.
- 24-month OS: 86.3%.
- Relatively few patients completed 35 cycles of pembrolizumab.
- Patients with EGFR/ALK alteration were underrepresented.