TABLE 5

Randomised trials with anti-PD-1/PD-L1 drugs in advanced, previously untreated nonsmall cell lung cancer (NSCLC) patients

TrialSubjectsHistologyPD-L1 expressionTherapyRRmPFS monthsmOS months
SelectionPositivityTest/cloneAllPD-L1+PD-L1AllPD-L1+PD-L1AllPD-L1+PD-L1
KEYNOTE-024 (phase III) [130]305NSCLCYes (≥50%)≥50%Dako/22C3Platinum doublet27.8%6  NR
Pembrolizumab44.8%10.3 (HR 0.50)  NR (HR 0.60)
CheckMate 026 (phase III) [131]541NSCLCYes (≥1%)≥1–5%Dako/28-8Platinum doublet33.5%5.9 13.2 
Nivolumab26.1%  4.2 (HR 1.15)(HR 1.07) 14.4 (HR 1.02)(HR 0.90) 
KEYNOTE-021 (phase II) [132]123Non-SCCNo≥1–50%Dako/22C3Carboplatin+pemetrexed29%35%13%8.9NR
Carboplatin+pemetrexed+pembroliozumab55%80%57%13 (HR 0.53)NR

PD-L1+ data from CheckMate 026 and KEYNOTE-021 trials refer to patients with at least 50% of tumour-cell positivity; hazard ratios (HRs) data take nivolumab as reference. RR: response rate; mPFS: median progression-free survival; mOS: median overall survival; NR: not reached; SCC: squamous cell carcinoma. Italics indicate statistically nonsignificant results.