Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types
Background Multiple PD-L1 immunohistochemistry (IHC) assays, including DAKO 22C3, DAKO 28-8, and Ventana SP142 PD-L1 IHC assays, have been approved by the Food and Drug Administration as a companion diagnostic (CDx) for various antiprogrammed death-1 and antiprogrammed death ligand 1 (PD-L1) based c...
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| Language: | English |
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BMJ Publishing Group
2022-10-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/10/10/e005573.full |
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| author | Jeffrey S Ross Richard S P Huang Jake G Maule Lani K Clinton Ryon P Graf Jinpeng Xiao Geoffrey R Oxnard |
| author_facet | Jeffrey S Ross Richard S P Huang Jake G Maule Lani K Clinton Ryon P Graf Jinpeng Xiao Geoffrey R Oxnard |
| author_sort | Jeffrey S Ross |
| collection | DOAJ |
| description | Background Multiple PD-L1 immunohistochemistry (IHC) assays, including DAKO 22C3, DAKO 28-8, and Ventana SP142 PD-L1 IHC assays, have been approved by the Food and Drug Administration as a companion diagnostic (CDx) for various antiprogrammed death-1 and antiprogrammed death ligand 1 (PD-L1) based cancer immunotherapies. Here we present 22C3, 28-8, and SP142 analysis of 418 tumor specimens encountered in routine clinical practice.Methods All specimens were tested with 22C3, 28-8, and SP142 assays following the manufacturer’s established staining protocols.Results The same PD-L1 status (defined as tumor cell expression (TC) scores with all three assays ≥1% or all <1%) was observed in 60.0% (251/418) tumor specimens (45.9% (192/418) were triple negative and 14.1% (59/418) were triple positive). A total of 54.1% (226/418) tumor cases were positive with at least one IHC assay (94.2% (213/226), 77.0% (174/226), and 28.8% (65/226) of these were positive for 22C3, 28-8 and SP142, respectively). Among the 40.0% (167/418) tumor cases that showed a different PD-L1 status, 62.3% (104/167) were 22C3+/28-8+/SP142−, and 28.7% (48/167) were 22C3+/28-8−/SP142−. The same PD-L1 status with all three antibody clones was observed in 48.7% (97/199) of NSCLC cases, and among these, 54.6% (53/97) were triple negative and 45.4% (44/97) triple positive. A total of 73.4% (146/199) NSCLC cases were positive with at least one IHC assay (95.2% (n=139/146), 82.2% (n=120/146), and 32.2% (n=47/146) were positive for 22C3, 28-8, and SP142, respectively). Among the 51.3% (102/199) NSCLC cases that showed a different status among the three IHC assays, 67.6% (69/102) were 22C3+/28-8+/SP142−, and 23.5% (24/102) were 22C3+/28-8−/SP142−. A total of 81.1% (43/53) lung squamous cell carcinoma, 72.1% (88/122) of lung adenocarcinoma, 69.6% (16/23) of non-small cell lung cancer (NSCLC) not otherwise specified (NOS), and 50.0% (4/8) of small cell lung carcinoma cases were positive with at least one IHC assay.Conclusions Our data suggest that 22C3 is the most sensitive PD-L1 IHC assay for tumor cell expression, followed by 28-8 and in turn by SP-142. These findings represent an additional factor for clinical teams to consider when deciding which PD-L1 IHC assay (and in turn which CDx-associated PD-L1 based immunotherapy) is most appropriate for each individual patient. |
| format | Article |
| id | doaj-art-ff1128964776465ea8e84fbd8f9bd504 |
| institution | Kabale University |
| issn | 2051-1426 |
| language | English |
| publishDate | 2022-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-ff1128964776465ea8e84fbd8f9bd5042025-02-09T14:00:10ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262022-10-01101010.1136/jitc-2022-005573Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor typesJeffrey S Ross0Richard S P Huang1Jake G Maule2Lani K Clinton3Ryon P Graf4Jinpeng Xiao5Geoffrey R Oxnard6Foundation Medicine Inc, Boston, Massachusetts, USAFoundation Medicine Inc, Cambridge, Massachusetts, USAFoundation Medicine Inc, Cambridge, Massachusetts, USAFoundation Medicine Inc, Cambridge, Massachusetts, USAFoundation Medicine Inc, San Diego, California, USAFoundation Medicine Inc, Cambridge, Massachusetts, USABoston Medical Center, Boston, Massachusetts, USABackground Multiple PD-L1 immunohistochemistry (IHC) assays, including DAKO 22C3, DAKO 28-8, and Ventana SP142 PD-L1 IHC assays, have been approved by the Food and Drug Administration as a companion diagnostic (CDx) for various antiprogrammed death-1 and antiprogrammed death ligand 1 (PD-L1) based cancer immunotherapies. Here we present 22C3, 28-8, and SP142 analysis of 418 tumor specimens encountered in routine clinical practice.Methods All specimens were tested with 22C3, 28-8, and SP142 assays following the manufacturer’s established staining protocols.Results The same PD-L1 status (defined as tumor cell expression (TC) scores with all three assays ≥1% or all <1%) was observed in 60.0% (251/418) tumor specimens (45.9% (192/418) were triple negative and 14.1% (59/418) were triple positive). A total of 54.1% (226/418) tumor cases were positive with at least one IHC assay (94.2% (213/226), 77.0% (174/226), and 28.8% (65/226) of these were positive for 22C3, 28-8 and SP142, respectively). Among the 40.0% (167/418) tumor cases that showed a different PD-L1 status, 62.3% (104/167) were 22C3+/28-8+/SP142−, and 28.7% (48/167) were 22C3+/28-8−/SP142−. The same PD-L1 status with all three antibody clones was observed in 48.7% (97/199) of NSCLC cases, and among these, 54.6% (53/97) were triple negative and 45.4% (44/97) triple positive. A total of 73.4% (146/199) NSCLC cases were positive with at least one IHC assay (95.2% (n=139/146), 82.2% (n=120/146), and 32.2% (n=47/146) were positive for 22C3, 28-8, and SP142, respectively). Among the 51.3% (102/199) NSCLC cases that showed a different status among the three IHC assays, 67.6% (69/102) were 22C3+/28-8+/SP142−, and 23.5% (24/102) were 22C3+/28-8−/SP142−. A total of 81.1% (43/53) lung squamous cell carcinoma, 72.1% (88/122) of lung adenocarcinoma, 69.6% (16/23) of non-small cell lung cancer (NSCLC) not otherwise specified (NOS), and 50.0% (4/8) of small cell lung carcinoma cases were positive with at least one IHC assay.Conclusions Our data suggest that 22C3 is the most sensitive PD-L1 IHC assay for tumor cell expression, followed by 28-8 and in turn by SP-142. These findings represent an additional factor for clinical teams to consider when deciding which PD-L1 IHC assay (and in turn which CDx-associated PD-L1 based immunotherapy) is most appropriate for each individual patient.https://jitc.bmj.com/content/10/10/e005573.full |
| spellingShingle | Jeffrey S Ross Richard S P Huang Jake G Maule Lani K Clinton Ryon P Graf Jinpeng Xiao Geoffrey R Oxnard Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types Journal for ImmunoTherapy of Cancer |
| title | Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types |
| title_full | Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types |
| title_fullStr | Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types |
| title_full_unstemmed | Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types |
| title_short | Comparison of PD-L1 tumor cell expression with 22C3, 28-8, and SP142 IHC assays across multiple tumor types |
| title_sort | comparison of pd l1 tumor cell expression with 22c3 28 8 and sp142 ihc assays across multiple tumor types |
| url | https://jitc.bmj.com/content/10/10/e005573.full |
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