TABLE 4

Practice-changing randomised trials with anti-PD-1/PD-L1 drugs in advanced, pre-treated (second-line) nonsmall cell lung cancer (NSCLC) patients

TrialSubjectsHistologyPD-L1 expressionTherapyRRmPFS monthsmOS months
SelectionPositivityTest/cloneAllPD-L1+PD-L1AllPD-L1+PD-L1AllPD-L1+PD-L1
CheckMate 017 (phase III) [125]272SCCNo≥1%Dako/28-8Docetaxel9%11%10%2.82.8367.25.9
Nivolumab20%17%17%3.5 (HR 0.62)3.3 (HR 0.67)3.1 (HR 0.66)9.2 (HR 0.59)9.3 (HR 0.69)8.7 (HR 0.58)
CheckMate 057 (phase III) [126]582Non-SCCNo≥1%Dako/28-8Docetaxel12%12%15%4.24.53.69.49 10.1
Nivolumab19%31%9%2.3 (HR 0.92)4.2 (HR 0.7)2.1 (HR 1.19)12.2 (HR 0.73)17.7 (HR 0.58)10.5 (HR 0.87)
KEYNOTE-010 (phase III) [127]1034NSCLCYes
(≥1%)
≥1%Dako/22C3Docetaxel9%8%44.18.58.2
Pembrolizumab 2 mg·kg−118%30%3.9 (HR 0.88)5 (HR 0.59)10.4 (HR 0.71)14.9 (HR 0.54)
Pembrolizumab 10 mg·kg−119%29%4 (HR 0.79)5.2 (HR 0.59)12.7 (HR 0.61)17.3 (HR 0.50)
POPLAR (phase II) [128]287NSCLCNoTC1-3 or IC1-3VENTANA/SP142Docetaxel15%16%10%334.19.79.29.7
Atezolizumab15%18%8%2.7 (HR 0.94)2.8 (HR 0.85)1.7 (HR 1.12)12.6 (HR 0.73)15.5 (HR 0.59)9.7 (HR 1.04)
OAK (phase III) [129]850NSCLCNoTC1-3 or IC1-3VENTANA/SP142Docetaxel13%16%11%44.149.610.38.9
Atezolizumab13%18%8%2.8 (HR 0.95)2.8 (HR 0.91)2.6 (HR 1)13.8 (HR 0.73)15.7 (HR 0.74)12.6 (HR 0.75)

PD-L1+ data from KEYNOTE-010 refer to patients with at least 50% tumour-cell positivity; hazard ratio (HRs) take nivolumab as reference. RR: response rate; mPFS: median progression-free survival; mOS: median overall survival; SCC: squamous cell carcinoma. Italics indicate statistically nonsignificant results.