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Table 4 Immunohistochemistry assays for PD-L1 expression

From: Current status and perspectives in translational biomarker research for PD-1/PD-L1 immune checkpoint blockade therapy

Drug Antibody (marker) Rx line Tumor type Targeted cells Tumor specimen Cutoff point (%) ORR % in IHC+ cases (95 % CI) ORR % in IHC− cases (95 % CI) Predictive role P value References
Nivolumab 28-8 rabbit (Dako) 1 L Melanoma TCs Archival FFPE or new biopsy 5 58 (46,69) 41 (35,48) Yes 0.001 Larkin J (2015) [130]
Nivolumab + ipilimumab 72 (60,82) 55 (48,62) Yes 0.001
Nivolumab ≥2 L 5 44 (30,58) 20 (11,32) Yes NA Weber JS (2015) [128]
Nivolumab + ipilimumab 1 L 5 58 (37,78) 55 (42,69) No >0.05 Postow MA (2015) [4]
Nivolumab 1 L 5 53 (41,64) 33 (25,42) No >0.05 Robert C (2015) [129]
≥2 L NSCLC TCs Archival FFPE or new biopsy 1 31 (23,40) 9 (5,16) Yes 0.002 Paz-Ares L (2015) [156]; Updated in Borghaei H (2015) [126]
5 36 (26,46) 10 (6,17) Yes 0.002
10 37 (27,48) 11 (6,17) Yes 0.002
≥2 L Archival FFPE 1 17 (9,29) 17 (8,29) No 0.9364 Brahmer JR (2015) [125]
5 21 (10,37) 15 (8,25) No 0.2908
10 19 (8,36) 16 (9,26) No 0.6411
≥2 L Archival FFPE 1 20 (5,35) 13 (2,28) No >0.05 Rizvi NA (2015) [131]
5 24 (5,43) 14 (3,25) No
1 L Archival FFPE 5 31 (NA) 10 (NA) No >0.05 Gettinger SN (2015) [157]
Nivolumab + ipilimumab 1 L Archival FFPE 5 19 (NA) 14 (NA) No >0.05 Antonia SJ (2014) [158]
Nivolumab 5H1 and anti-PD-1 monoclonal M3 ≥2 L Archival FFPE 5 39 (34,44) 6 (1,12) Yes 0.025 Taube JM (2014) [113]
Pembrolizumab 22C3 mouse (Dako) ≥1 L NSCLC TCs and ICs New biopsy 50 45 (33,57) 17 (10,25) Yes 0.001 Garon EB (2015) [5]
1 L New biopsy 50 47 (23,72) 19 (8,38) Yes NA Rival NA (2015) [159]
Any Archival FFPE 1 25 (NA) 13 (NA) Yes NA Garon EB (2014) [160]
≥1 L Archival FFPE 50 30 (23,39) 9.8 (NA) Yes NA Herbst RS (2015) [140]
29 (22,37) 10.7 (NA)
1 L Archival FFPE 50 16 (NA) 10 (NA) Yes NA Garon EB (2014) [161]
Atezolizumab (MPDL3280A) SP142 rabbit (Roche Ventana) ≥2 L NSCLC TCs and ICs Archival FFPE and new biopsy 50 45 (23,68) 14 (6,25) Yes NA Leora H (2015) [162]
≥2 L NSCLC 1+ 31 (25,37) 20 (14,26) Yes 0.015 Herbst RS (2014) [145]
Solid Tumor 1+ 29 (27,31) 13 (10,16) Yes 0.007
≥2 L NSCLC 2+ 18 (NA) 8 (NA) Yes NA Spira AI (2015) [143]
Durvalumab (MEDI-4736) SP263 rabbit (Roche Ventana) ≥2 L NSCLC TCs Archival FFPE and new biopsy 25 39 (NA) 5 (NA) Yes NA Segal NH (2014) [163]
33 (13,59) 30 (16,47) No for combo NA Antonia SJ (2016) [155];
22 (3, 60) 29 (8, 58) No for monotherapy NA
  1. NA not available