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Table 2 Selected clinical trials of PD-1/PD-L1 immunotherapies according to cancer type

From: Development and clinical applications of cancer immunotherapy against PD-1 signaling pathway

TrialSubjectStudy vs. comparisonResultReferenceFDA approval outcome
Melanoma
 Keynote 006No prior immunotherapy, any PD-L1 levelP 10 mg/kg vs. IOS: 32.7 vs. 15.9 months
PFS: 8.4 vs. 3.4 months
Schachter et al. 2017FDA approved pembrolizumab for first-line treatment in advanced melanoma
 Keynote 002With prior ipilimumab, any PD-L1 levelP 2 mg/kg vs. P 10 mg/kg vs CPFS: 34% vs. 38% vs. 16%Ribas et al. 2015FDA approved pembrolizumab for second-line treatment in advanced melanoma
 CheckMate 066Previous untreated, any PD-L1 levelN 3 mg/kg vs. dacarbazineOS: 37.5vs. 11.2 months
PFS: 5.1 vs. 2.2 months
Ascierto et al. 2019FDA approved Opdivo for treatment of BRAF V600 wild-type unresectable or metastatic melanoma
 CheckMate 037With prior ipilimumab, any PD-L1 levelN 3 mg/kg vs. COS: 16 vs. 14 months
PFS: 3.1 vs. 3.7 months
ORR: 27% vs. 10%
Larkin et al. 2018FDA approved Opdivo for unresectable or metastatic melanoma following treatment with ipilimumab or BRAF inhibitor
 CheckMate 067Previous untreated, any PD-L1 levelN 3 mg/kg + I 3 mg/kg vs. N 3 mg/kg vs. I 3 mg/kgOS: not reached vs.
37.6 vs. 19.9 months
PFS: 11.5 vs. 6.9 vs.
2.9 months
Larkin et al. 2015FDA approved nivolumab in combination with ipilimumab for treatment of BRAFV600 wild-type and BRAF V600 mutation positive unresectable or metastatic melanoma
 CheckMate 511Previous untreated, any PD-L1 levelN 3 mg/kg + I 1 mg/kg vs. N 1 mg/kg + I 3 mg/kgPFS: 9.9 vs. 8.9 months
ORR: 45.6% vs. 50.6%
Grade 3 to 5 AEs: 34% vs. 48%
Lebbe et al. 2019 
Renal Cell Carcinoma
 CheckMate 025With prior treatment, any PD-L1 levelN 3 mg/kg vs. everolimusOS: 25 vs. 19.6 months
ORR: 22% vs. 4%
Escudier et al. 2017FDA approved nivolumab for treatment of advanced renal cell carcinoma with no prior anti-angiogenic therapy
 CheckMate 214Previous untreated intermediate to poor risk, any PD-L1 levelN 3 mg/kg + I 1 mg/kg vs. sunitinibOS: not reached vs. 26.6 months
PFS: 8.2 vs. 8.3 months
ORR: 42% vs. 29%
Motzer et al. 2019; Escudier et al. 2017FDA approved nivolumab and ipilimumab for treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma
Non-Small Cell Lung Cancer
 Keynote 024Previous untreated, with TPS over 50%P 200 mg vs. COS: 80.2% vs. 72.4%
PFS: 10.3 vs. 6 months
ORR: 44.8% vs. 27.8%
Reck et al. 2016FDA approved pembrolizumab for treatment of metastatic NSCLC whose tumors have high PD-LA expression with no EGFR or ALK genomic tumor aberrations
 Keynote 189Previous untreated, any PD-L1 levelP 200 mg + C vs. COS: not reached vs.
11.3 months
PFS: 8.8 vs. 4.9 months
Gandhi et al. 2018FDA approved pembrolizumab in combination with pemetrexed and platinum chemotherapy for first line treatment of metastatic non squamous NSCLC with no EGFR or ALK genomic tumor aberrations
 Keynote 010With prior treatment, any PD-L1 levelP 2 mg/kg vs. P 10 mg/kg vs. docetaxelTotal population
OS: 10.4 vs. 12.7 vs.
8.5 months
PFS: 3.9 vs. 4.0 vs. 4.0 months
TPS ≥ 50%
OS: 14.9 vs. 17.3 vs.
8.2 months
PFS: 5.0 vs. 5.2 vs. 4.1 months
Herbst et al. 2016FDA approved pembrolizumab as second-line treatment for PD-L1 Positive non-small cell lung cancer
 IMpower 150Nonsquamous, previous untreated, any PD-L1 levelA 1200 mg + C + bevacizumab 15 mg/kg vs.
C + bevacizumab
PFS: 8.3 vs. 6.8 monthsSocinski et al., 2018FDA approved atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin for first line treatment of metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations
Head and Neck Cancer
 Keynote 040With prior treatment, any PD-L1 levelP 200 mg vs. COS: 8.4 vs. 6.9 monthsCohen et al. 2018FDA approved pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of head and neck with disease progression on or after platinum-based therapy
 CheckMate 141With prior treatment, any PD-L1 levelN 3 mg/kg vs. COS7.5 vs. 5.1 monthsKiyota et al. 2017FDA approved nivolumab for treatment of recurrent or metastatic squamous cell carcinoma of head and neck with disease progression on or after platinum-based therapy
  1. A Atezolizumab, AEs Adverse events, C Chemotherapy, D Durvalumab, I Ipilimumab, N, Nivolumab, ORR Objective response rate, OS Overall survival, P Pembrolizumab, PFS Progression-free survival, TPS Tumor proportion score