ASTRUM-007 was a randomized, placebo-controlled, double-blind, phase 3 clinical study conducted at 70 hospitals in China (Supplementary Table 1 ). Eligible patients were aged 18–75 years with previously untreated, histologically confirmed, inoperable locally advanced or metastatic, PD-L1-positive (CPS ≥ 1) ESCC, with at least one measurable lesion based on central imaging in accordance with RECIST v1.1, adequate organ function, and Eastern Cooperative Oncology Group (ECOG) performance status 0–1. Tumors were centrally tested for PD-L1 immunohistochemistry (22C3 PharmDx kit, Dako North America). CPS is defined as the number of PD-L1–staining cells (tumor cells, lymphocytes and macrophages) as a proportion of the total number of viable tumor cells multiplied by 100. Patients were excluded if they had previously received PD-1 or PD-L1 inhibitors, had central nervous system metastases or presented with active infection or active autoimmune diseases. The full study protocol is provided in the Supplementary Information .
22c3 pharmdx kit
Manufactured by Agilent Technologies
Sourced in United States
The 22C3 pharmDx kit is a laboratory equipment product manufactured by Agilent Technologies. It is a diagnostic tool used for the detection and analysis of the PD-L1 protein expression in tumor samples.
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Lab products found in correlation
Dako automated link 48 platform, by Agilent Technologies (3 mentions)
Dako autostainer link 48, by Agilent Technologies (2 mentions)
Automated link 48 platform, by Agilent Technologies (1 mentions)
Cobas egfr mutation test, by Roche (1 mentions)
Dako autostainer link 48 system, by Agilent Technologies (1 mentions)
Ab14714, by Abcam (1 mentions)
Envision flex target retrieval solution, by Agilent Technologies (1 mentions)
Envision flex wash buffer, by Agilent Technologies (1 mentions)
Imagescope software, by Leica (1 mentions)
Clone ep49, by Novus Biologicals (1 mentions)
E1l3n xp rabbit mab, by Cell Signaling Technology (1 mentions)
Clone a16 4, by BD (1 mentions)
Clone g168 15, by BD (1 mentions)
Sp263, by Roche (1 mentions)
Dako autostainer link 48 platform, by Agilent Technologies (1 mentions)
19 protocols using 22c3 pharmdx kit
1
Randomized Trial of Pembrolizumab for Advanced ESCC
2
PD-L1 Expression Quantification Protocol
3
Evaluation of HER2, PD-L1, and MMR in Tumors
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HER2, programmed death ligand 1 (PD‐L1), and mismatch repair (MMR) status were evaluated through IHC. HER2 expression was analyzed using the anti‐HER‐2 (4B5) rabbit monoclonal primary antibody (Ventana, U.S.). HER2 positivity was defined as IHC 3+ or both IHC 2+ and FISH positive. IHC of MLH1, MSH2, MSH6, and PMS2 was performed with a BenchMark ULTRA slide processing system (Ventana, U.S.) according to the manufacturer's instructions. Tumors were defined as deficient mismatch repair (dMMR) only if at least one of the proteins was absent of staining in the tumor cells; otherwise, proficient mismatch repair (pMMR) was deemed. PD‐L1 staining was performed using a 22C3 pharmDx kit (Dako, Denmark). A combined positive score (CPS, defined as the total number of tumor cells and immune cells stained positive divided by the number of viable tumor cells, then multiplied by 100) of 1 or higher was considered PD‐L1 positive.
4
PD-L1 Expression and EGFR Mutation in Tumor Samples
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All viable cancer cells on the entire pathological tissue section of each tumor sample were evaluated. We used the PD-L1 clone 22C3 pharmDx kit and Dako Automated Link 48 platform (Agilent Technologies, Dako, Carpinteria, CA, USA) to measure the PD-L1 expression. The PD-L1 tumor proportion score (TPS) was calculated as the percentage of complete or partial membrane staining in a sample. The cut-off value for the expression of PD-L1 was set at 50% and 1% based on a previous clinical trial23 (link). The tumor samples of each patient were separated into 3 groups based on the presence of positivity stained cells in specimen, as follows: < 1% (negative), 1–49% (low expression), and ≥ 50% (high expression). All patients were subjected to an EGFR mutation assay by the testing laboratories (Cobas EGFR Mutation Test; Roche Molecular Diagnostics, Pleasanton, CA, USA).
5
PD-L1 Expression Analysis Protocol
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PD-L1 expression was determined by IHC using the Dako 22C3 pharmDx kit, considering more than 100 tumor cells in the slide section for accurate PD-L1 readings. PD-L1 testing was completed on biopsies taken at diagnosis. For survival analyses, patients were stratified according to PD-L1 status (i.e., ≥ 50%, 1–49%, and < 1% subgroups). Patients with unknown PD-L1-expression status were also included in this study.
6
Immunohistochemical Evaluation of PD-L1 in FFPE Tissues
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Formalin-fixed and paraffin-embedded (FFPE) tissues were used for immunohistochemistry to determine PD-L1 levels by two experienced pathologists, using an anti-human PD-L1 antibody (22C3 pharmDx kit; Dako, Carpinteria, CA) according to the manufacturer’s recommendations. The PD-L1 expression level was evaluated by tumor proportion score (TPS) and TPS ≥1% was identified as positive. PD-L1 TPS ≥ 50% was defined as strong PD-L1 positivity.
7
Tumor Staging and PD-L1 Assessment
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The surgical specimens were staged according to the criteria of the American Joint Committee on Cancer (eighth edition)31 (link) by two expert oncopathologists independently. Routine H&E staining of primary tumors was assessed for pathological regression according to the criteria of the College of American Pathologists/National Comprehensive Cancer Network.32 Since there is no consensus about carcinoma in situ (CIS) classification, we considered CIS as a pCR as stated in the Miller and Payne system for breast cancer.33 (link) Scanned slides containing lymph node slices were identified, reviewed, and classified, as described previously.34 (link) Programmed death ligand 1 (PD-L1) expression was determined using the 22C3 pharmDx kit (Dako North America, Carpinteria, California, USA), according to the manufacturer’s instructions, and the combined positive score (CPS) was defined as reported previously.11 (link)
8
Assessing PD-L1 Expression in Tumor Tissue
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PD‐L1 immunohistochemical staining in tumor tissue was processed in tissue sections (3‐μm thick) using the 22C3 clone (22C3 PharmDx Kit, Dako) and analyzed by the practicing anatomic pathologist blinded to CTCs analysis. The PD‐L1 protein tumor proportion score (TPS) was assessed based on the proportion of partial or complete staining (≥1%) cells relative to all viable tumor cells.
9
PD-L1 Expression Analysis in Biopsies
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PD-L1 expression was determined by immunohistochemistry using the Dako 22C3 pharmDx kit, with more than 100 tumor cells present in the slide section for accurate PD-L1 readings. PD-L1 testing was completed on biopsies taken at diagnoses. Patients were grouped according to PD-L1 status (i.e., ≥50%, 1–49%, and <1% subgroups) for survival analyses. Patients with unknown PD-L1 expression status were also included in this study to reflect real-world durvalumab use.
10
Assessing PD-L1 Expression in NSCLC
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For each tumor sample, the histological subtype of carcinomatous components (adenocarcinoma, squamous cell carcinoma, and large-cell carcinoma) and sarcomatoid components were collected.
To measure the PD-L1 expression, we used the PD-L1 clone 22C3 pharmDx kit and Dako Automated Link 48 platform (Dako, Carpenteria, USA), which is clinically used for the evaluation of the PD-L1 expression in NSCLC at our institution. The PD-L1 expression was calculated as the percentage of complete or partial membrane staining in a section that included at least 100 viable tumor cells. Necrotic areas were excluded from scoring. A high expression of PD-L1 was defined as ≥50% staining of tumor cell membrane, and PD-L1 negative was defined as <1% staining.
To measure the PD-L1 expression, we used the PD-L1 clone 22C3 pharmDx kit and Dako Automated Link 48 platform (Dako, Carpenteria, USA), which is clinically used for the evaluation of the PD-L1 expression in NSCLC at our institution. The PD-L1 expression was calculated as the percentage of complete or partial membrane staining in a section that included at least 100 viable tumor cells. Necrotic areas were excluded from scoring. A high expression of PD-L1 was defined as ≥50% staining of tumor cell membrane, and PD-L1 negative was defined as <1% staining.
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