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Table 4 Biomarker data reported with ICIs in advanced RCC

From: The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of advanced renal cell carcinoma (RCC)

TrialDescriptionResults (combination vs. SOC), 95% CI
OSPFS (months)Objective Response
CheckMate 025
(NCT01668784)
[16]
Nivolumab vs. EverolimusPD-L1 τ (< 1%) a
mOS: 27.4 vs. 21.2 mo (HR 0.77; 0.60 to 0.97)
PD-L1 τ (≥1%) a
mOS: 21.8 vs. 18.8 mo (HR 0.79; 0.53 to 1.17
  
CheckMate 214
(NCT02231749)
[9]
Nivolumab + Ipilimumab vs. SunitinibPD-L1 τ (< 1%) a
HR 0.73; 95% CI, 0.56 to 0.96
12-mo rate: 80% vs. 75%
18-mo rate; 74% vs. 64%
PD-L1 τ (≥1%) a
HR 0.45; 0.29 to 0.71
12-mo rate: 86% vs. 66%
18-mo rate: 81% vs. 53%
Sarcomatoid Histology
HR 0.56; 0.38–0.83
PD-L1 (≥1%) prevalence: 50% (SH) vs. 27.5% (non-SH)
PD-L1 τ (< 1%) a
mPFS: 11.0 vs. 10.4 (HR 1.00; 0.8 to 1.26)
PD-L1 τ (≥1%) a
mPFS: 22.8 vs. 5.9 (HR 0.46; 0.31 to 0.67)
PD-L1 τ (< 1%) a
ORR: 37% vs. 28%, p = 0.03
PD-L1 τ (≥1%) a
ORR: 58% vs. 22%, p < 0.001
Sarcomatoid Histology
ORR: 56.7% vs. 19.2%, P < .0001
CR: 18.3% vs. 0%
Keynote-426
(NCT02853331)
[11] [insert ASCO abstract 4500]
Pembrolizumab + Axitinib vs. SunitinibPD-L1 β (< 1%) b
HR 0.59; 0.34 to 1.03
PD-L1 β (≥1%) b
HR 0.54; 0.35 to 0.84
Sarcomatoid Histology
12-mo OS: 83.4% vs 79.5% (HR 0.58; 0.21 to 1.59)
PD-L1 β (< 1%) b
HR 0.87; 0.62 to 1.23
PD-L1 β (≥1%) b
HR 0.62; 0.47 to 0.80
Sarcomatoid Histology
mPFS: NR vs. 8.4 (HR 0.54; 0.29 to 1.00)
Sarcomatoid Histology
ORR: 58.8% vs 31.5%
CR: 11.8% vs. 0%
Javelin RENAL 101
(NCT02684006)
[12, 13]
Avelumab + Axitinib vs. SunitinibNot available.PD-L1¥ + (≥1%) c
mPFS: 13.8 vs 7.2 (HR 0.61; 0.47 to 0.79; P < 0.001)
PD-L1¥- (< 1%) c
mPFS: 16.1 vs. 11.1
PD-L1¥ + (≥1%) c
ORR: 55.2% vs 25.5%
CR: 4.4% vs. 2.1%
PD-L1¥- (< 1%) c
ORR: 47% vs. 28%
IMmotion150
[46]
Atezolizumab + Bevacizumab or Atezolizumab monotherapy vs. SunitinibNot available.ITT Population
Combination HR 1.0; 0.69 to 1.45
Monotherapy HR 1.19; 0.82 to 1.71
PD-L1¥ + (≥1%) d
Combination HR 0.64; 0.38 to 1.08
Monotherapy HR 1.03; 0.63 to 1.67
PD-L1¥ + (≥1%) d
48% (combination) and 28% (monotherapy) vs. 27%
IMmotion151
(NCT02420821)
[14] [insert ASCO abstract citation]
Atezolizumab + Bevacizumab vs. SunitinibPD-L1¥ + (≥1%) d
OS: 75% vs. 65% (HR 0.68; 0.46–1.0; p = 0.0470)
Sarcomatoid Histology
All Sarc
mOS: NR vs. 15.0 (HR: 0.56; 0.32 to 0.96)
12-mo OS: 69% vs. 60%
PD-L1+ Sarc
mOS: NR vs. 15.0 (HR: 0.53; 0.27 to 1.06)
12-mo OS: 71% vs. 61%
PD-L1¥ + (≥1%) d
mPFS: 11.2 vs. 7.7 (HR 0.74; 0.57 to 0.96; p = 0.0217)
Sarcomatoid Histology
All Sarc
mPFS: 8.3 vs. 5.3 (HR: 0.52; 0.34 to 0.79)
PD-L1+ Sarc
mOS: 8.6 vs. 5.6 (HR: 0.45; 0.26 to 0.77)
Gene Expression Signatures
High Teff
mPFS: 12.45 vs. 8.34 (HR 0.76; 0.59–0.99)
Low Teff
mPFS: 9.72 vs. 8.41 m
High angiogenesis
mPFS: 12.45 vs. 10.2 (HR 0.95; 0.75–1.19)
Low angiogenesis
mPFS: 8.94 vs. 5.95 (HR 0.68; 0.52–0.89)
PD-L1¥ + (≥1%) d
ORR: 43% vs 35%
Sarcomatoid Histology
All Sarc
ORR: 49% vs. 14%
CR: 10 vs. 3%
PD-L1+ Sarc
ORR: 56% vs. 12%
CR: 14% vs. 4%
  1. SH Sarcomatoid Histology
  2. Cell population used: τ = tumor cells, ¥ = immune cells, β = both tumor and immune cells
  3. Antibody used: a = Rabbit 28–8 (Dako), b = Mouse 22C3 (pharmDx), c = Rabbit SP263 (Ventana), d = Rabbit SP142 (Ventana)