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Table 1 Clinical trials on immune checkpoint inhibitors in non–small cell lung cancer

From: Immunotherapy for non-small cell lung cancers: biomarkers for predicting responses and strategies to overcome resistance

Name of trial Phase Histology/ line of treatment Randomization No. Cases First end point results ORR (RECIST) Effect of PD-L1 expression
CheckMate 017 III SqNSCLC/ second Nivolumab at 3 mg/kg vs. docetaxel at 75 mg/m2 272 Significant improvement in OS for patients receiving nivolumab compared with docetaxel (median, 9.2 vs. 6.0 mo; HR, 0.59; p < .001). Response rate was 20% with nivolumab vs. 9% with docetaxel (P = 0.008) PD-L1 expression was neither prognostic nor predictive for efficacy end points
CheckMate 057 III Non-SqNSCLC/second Nivolumab at 3 mg/kg vs. docetaxel at 75 mg/m2 582 Significant improvement in OS for patients receiving nivolumab compared with docetaxel (median 12.2 vs. 9.4 mo; HR, 0.73; p = .002). Response rate was 19% with nivolumab vs. 12% with docetaxel (P = 0.02) PD-L1 expression was associated with even greater efficacy at all expression levels (≥1%, ≥5%, and ≥ 10%).
KEYNOTE 010 II/III NSCLC PD-L1-positive tumors (PS ≥ 1%)/second Pembrolizumab at 2 mg/kg or 10 mg/kg vs. docetaxel 75 mg/m2 1034 Significant improvement in OS for pembrolizumab at 2 mg/kg (median 10.4 vs. 8.5 mo; HR, 0.71; p = .0008) and pembrolizumab at 10 mg/kg (median, 12.7 vs. 8.5 mo; HR, 0.61; p < .001) compared with docetaxel Response rate was 18% with pembrolizumab (2 mg and 10 mg vs. 9% with docetaxel (P = 0.0005 and 0.0002) Pembrolizumab efficacy was greater in patients with tumor PS ≥50%
KEYNOTE 024 III NSCLC, PD-L1-positive tumors (PS ≥50%), no sensitizing mutation of EGFR or translocation of ALK/first Pembrolizumab at fixed dose of 200 mg or platinum-based chemotherapy 305 Significant improvement in PFS for patients receiving pembrolizumab compared with chemotherapy (median 10.3 vs. 6.0 mo; HR, 0.5; p < .00001). Response rate was 44.8% with pembrolizumab vs. 27.8% with chemotherapy All patients, PD-L1 expression on at least 50% of tumor cells
POPLAR II NSCLC/ second Atezolizumab 1200 mg vs. docetaxel 75 mg/m2 287 Significant improvement in OS for patients receiving atezolizumab compared with docetaxel (median, 12.6 vs. 9.7 mo; HR, 0.73; P = .04) Objective responses with atezolizumab were durable, with a median duration of 14·3 months (95% CI 11·6–non-estimable) compared with 7·2 months (5·6–12·5) for docetaxel As with OS, PFS and ORR tended to show increased atezolizumab benefit with increasing PD-L1 expression.
OAK III NSCLC/ second Atezolizumab at 1200 mg vs. docetaxelat 75 mg/m2 850 Significant improvement in OS for patients receiving atezolizumab compared with docetaxel (median 13.8 vs. 9.6 mo; HR, 0.73; P = .0003). For ITT population, response rate was 14% with atezolizumab vs. 13% with docetaxel Overall survival was improved regardless of PD-L1 expression levels. Patients with tumors expressing high levels of PD-L1 (TC3 or IC3) derived the greatest benefit from atezolizumab
PACIFIC III Stage III NSCLC with no disease progression after ≥2 cycles of chemoradiotherapy/second Durvalumab at 10 mg/kg vs. placebo 709 Significant improvement in PFS and OS for patients with durvalumab vs. with placebo (PFS median 17.2 vs. 5.6 mo; HR, 0.51, P < 0.001; HR for OS =0.68, P = 0,0025); Response rate was 28% with durvalumab vs. 16% with placebo PFS and OS benefits with durvalumab were observed in all subgroups, including PD-L1 expression ≥25% or < 25%
  1. Abbreviations: OS overall survival, NSCLC non–small cell lung cancer, Sq squamous, HR hazard ratio, ORR objective response rate, ITT Intent to treat, PD-1, programmed cell death protein-1, PD-L1 programmed cell death ligand-1, PS proportion score