TABLE 1

Overall survival (OS) according to PD-L1 expression, grade 3 adverse events and treatment discontinuations in trials evaluating immune checkpoint inhibitors in non-small cell lung cancer

TrialSchedulenOS months HR (95% CI)PD-L1 <1%
HR (95% CI)
PD-L1 1–49%
HR (95% CI)
PD-L1 ≥50%
HR (95% CI)
Grade ≥3 AE (%)Discontinuations (%)
CheckMate 026 [29]N versus CT (PD-L1≥5%)42314.4 versus 13.2
1.02 (0.80–1.30)
Not tested1.07 (0.77–1.49)18% versus 51%
CheckMate 227 [19, 20]#,¶N+I versus CT, Part 1 (All comers)116617.1 versus 14.9§
0.76 (0.67–0.93)
0.64 (0.51–0.81)ƒ0.94 (0.73–1.12)ƒ0.70 (0.55–0.90)ƒ33% versus 36%12% versus 5%
KEYNOTE 024 [35]#,P versus CT (PD-L1≥50%)30526.3 versus 14.2
0.65 (0.50–0.86)
Not testedNot tested0.65 (0.50–0.86)31% versus 53%14% versus 11%
KEYNOTE 042 [16]#,P versus CT (PD-L1≥1%)127416.4 versus 12.1§
0.82 (0.71–0.93)
Not tested0.91 (0.77–1.09)ƒ0.70 (0.58–0.86)18% versus 41%10% versus 10%
IMpower 110 [17]#A versus CT (PD-L1≥1%)57217.5 versus 14.1
0.83 (0.65–1.07)
Not tested0.83 (0.65–1.07)0.59 (0.40–0.89)17% versus 48%6% versus 16%
EMPOWER-lung 1 [18]C versus CT (PD-L1≥50%)563NR versus 14.2
0.57 (0.42–0.77)
Not testedNot tested0.57 (0.42–0.77)37% versus 49%4.2% versus 2.3%
CheckMate-9LA [28]#,N+I+CT versus CT (All comers)71915.6 versus 10.9
0.66 (0.55–0.80)
0.62 (0.45–0.85)0.61 (0.44–0.84)0.66 (0.44–0.99)47% versus 38%19% versus 7%
CCTG BR.34
[40]
D+T+CT versus D+T (All comers)30116.6 versus 14.4 0.88 (0.67–1.16)0.61 (0.40–0.92)Not reported0.61 (0.32–1.19)82% versus 14%23% versus 14%
KEYNOTE 189 [21]#,P+CT versus CT, No-Sq. (All comers)61622.0 versus 10.6
0.56 (0.46–0.69)
0.51 (0.36–0.71)0.66 (0.46–0.96)0.59 (0.40–0.86)72% versus 67%36% versus 17%
KEYNOTE 407 [26]#,P+CT versus CT, Sq. (All comers)55817.1 versus 11.6
0.71 (0.58–0.88)
0.79 (0.56‒1.11)ƒ0.59 (0.42‒0.84)ƒ0.79 (0.52‒1.21)ƒ74% versus 70%27% versus 13%
IMpower 131 [31]A+CT versus CT, Sq. (All comers)102114.2 versus 13.5
0.88 (0.73–1.05)
0.87 (0.67–1.13)1.08 (0.81–1.45)0.48 (0.29‒0.81)∼75% versus 70%∼30% versus 17%
IMpower 130 [22]#,A+CT versus CT, No-Sq. (All comers)72418.6 versus 13.9
0.79 (0.64–0.98)
0.81 (0.61–1.08)ƒ0.70 (0.45–1.08)ƒ0.84 (0.51–1.39)ƒ75% versus 61%26% versus 22%
IMpower 150 [23, 24]#,ABCP versus BCP, No-Sq. (All comers)+69619.2 versus 14.7
0.78 (0.69–0.96)
0.82 (0.62–1.08)ƒ0.80 (0.55–1.15)ƒ0.70 (0.43–1.13)ƒ60% versus 51%34% versus 25%
IMpower 132 [30]A+CT versus CT, No-Sq. (All comers)57817.5 versus 13.6
0.86 (0.71–1.06)
Not reportedNot reportedNot reported
ORIENT-11
[25]
S+CT versus CT No-Sq. (All comers). Asian397NR versus NR
0.61 (0.40–0.93)
Not reportedNot reportedNot reported62% versus 59%6% versus8.4%
ORIENT-12 [27]S+CG versus CG Sq. (All comers). Asian357NR versus NR
0.57 (0.35–0.91)
Not reportedNot reportedNot reported87% versus 83%10% versus8%

N: Nivolumab; I: Ipilimumab; P: Pembrolizumab; A: Atezolizumab; B: Bevacizumab; C: Cemiplimab; D: Durvalumab; S: Sintilimab; T: Tremelimumab; CP: carboplatin and paclitaxel; CT: chemotherapy; CG: Cisplatin/Carboplatin and Gemcitabine; AE: adverse events; NR: not reached; Sq: Squamous. #: European Medicines Agency approval; : US Food and Drug Administration approval; +: Table only includes data from arm B versus C of IMpower150 trial (wild-type, intention to treat); §: OS in PD-L1 ≥1%; ƒ: exploratory analysis.