Efficacy and survival outcomes were analyzed as prespecified secondary endpoints and included objective response rate (confirmed complete or partial response) assessed in response-evaluable patients, and progression-free survival and OS, assessed in the intention-to-treat population. Objective response rate and progression-free survival were investigator assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, based on the May 15, 2020, data cut-off. For tumor assessment, computed tomography or magnetic resonance imaging was performed at screening and at protocol-specified intervals (every 9 weeks for the first 6 months, then every 12 weeks thereafter) until disease progression, withdrawal of consent, or receipt of subsequent anticancer therapy. OS was analyzed following the final database lock on July 17, 2020. Genetic and/or expression markers in blood and tumors and immunologic markers, including PD-L1 expression, were analyzed as post hoc exploratory objectives. Baseline PD-L1 status was measured using the Ventana SP142 PD-L1 assay; tumors were scored as PD-L1 positive if the proportion of PD-L1-expressing tumor-infiltrating immune cells was ≥ 1% and PD-L1 negative if < 1%, per the assay interpretation guide for TNBC tumors [25 ].
Pd l1 sp142 assay
Manufactured by Roche
Sourced in Azerbaijan, United States
The PD-L1 (SP142) assay is a qualitative immunohistochemistry (IHC) assay designed to detect the expression of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. The assay utilizes the SP142 antibody clone to identify PD-L1 expression on tumor cells and tumor-infiltrating immune cells.
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11 protocols using pd l1 sp142 assay
1
PD-L1 Expression in TNBC Patients
2
PD-L1 IHC Testing Protocols for Solid Tumors
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PD-L1 IHC testing was run and interpreted by board-certified pathologists according to the manufacturer instructions in a CLIA-certified and CAP-accredited laboratory (Foundation Medicine, Morrisville, North Carolina) for a subset of specimens in this cohort.20 21 Specially, we examined the tumor types with a PD-L1 CDx approval: DAKO 22C3 PD-L1 assay for NSCLC (tumor proportion score cut-off ≥1), cervical carcinoma (combined positive score (CPS) cut-off ≥1), head and neck SCC (CPS cut-off ≥1), gastric/gastroesophageal adenocarcinoma (CPS cut-off ≥1), urothelial carcinoma (CPS cut-off ≥10), and esophageal SCC (CPS cut-off ≥10); and VENTANA SP142 PD-L1 assay for breast carcinoma at tumor infiltrating immune cell cut-off of 1%.22–24
3
Evaluating PD-L1 Expression in Tumor Assessment
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Tumour assessment was conducted at baseline, then every 8 weeks for 12 months and every 12 weeks thereafter. Follow-up for survival occurred every 3 months after treatment discontinuation. The primary endpoints were investigator-assessed PFS and OS and were assessed in both the ITT population and PD-L1–positive (PD-L1 ≥ 1% on IC) subgroup, using the VENTANA SP142 PD-L1 assay. Secondary endpoints were investigator-assessed objective response rate (ORR) and duration of response (DOR) per RECIST 1.1. Safety was evaluated per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
4
Atezolizumab plus Paclitaxel for aTNBC
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The French EAP was accessible to all patients and centers in France. Eligibility criteria were: patients aged 18 years old and more; aTNBC (estrogen and progesterone receptors < 10%, HER2-negative), by local assessment on the most recent tumor tissue available (i.e. patients presenting with a documented triple negative relapse of a previously treated non-triple negative primary tumor were eligible); no prior systemic treatment for aTNBC; PD-L1-positive (≥ 1%), using the Ventana PD-L1 SP142 assay and an immune cell score, which refers to the area occupied by PD-L1 positive immune cells as a percentage of the whole tumor area.
All patients treated as part of the EAP were prospectively registered at their site. They received a 1200 mg atezolizumab infusion every 21 days in addition to weekly paclitaxel, until progression, death, toxicity, or medical or patient decision.
All patients treated as part of the EAP were prospectively registered at their site. They received a 1200 mg atezolizumab infusion every 21 days in addition to weekly paclitaxel, until progression, death, toxicity, or medical or patient decision.
5
Immunohistochemical Analysis of Tumor Markers
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All surgical specimens underwent immunohistochemical staining of Ki‐67 and P53 by the EliVision Plus method. Levels of PD‐L1 were evaluated by VENTANA PD‐L1 (SP142) Assay in formalin‐fixed tumor samples from tumor tissues. The signal intensity of Ki‐67 and P53 was categorized into 3 grades: 10% or less, 11%‐49%, and 50% or more. As no patient had PD‐L1 expression on 50% or more of tumor cells and 10% or more of tumor‐infiltrating immune cells, PD‐L1 was stratified by TC0 and IC0, and TC1/2 or IC1/2. TC0 and IC0 were defined as PD‐L1 expression on less than 1% tumor cells and tumor‐infiltrating immune cells, respectively. TC1/2 was defined as PD‐L1 expression on 1% or more but less than 50% of tumor cells. IC1/2 was defined as PD‐L1 expression on 1% or more but less than 10% of tumor‐infiltrating immune cells.6
6
PD-L1 Immunohistochemistry for Immunotherapy
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Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) was performed regularly in tandem with CGP to guide patient selection for immunotherapy. PD-L1 protein expression was assessed by IHC on 5-micron FFPE tissue sections using the Dako PD-L1 IHC22C3 pharmDx assay (Agilent; Santa Clara, CA; n = 52 vSCCs) or the Ventana (Oro Valley, AZ) PD-L1 (SP142) assay (n = 21 vSCCs), following each manufacturer’s instructions. Dako PD-L1 expression was reported as a tumor proportion score, and Ventana PD-L1 was reported as percent tumor area covered by positively staining tumor cells and immune cells. Less than 1% staining was defined as negative, 1%-49% was defined as low positive, and ≥ 50% was defined as high positive.
7
Immunohistochemical Analysis of Immune Markers
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Immunohistochemistry for CD3, CD8, PD-L1, and PD-1 were performed with CONFIRM anti-CD3 (2GV6) antibody (VENTANA, 790–4341), (790–4460) CONFIRM CD8 (SP57) antibody (VENTANA, 790–4460), PD-L1 (SP142) Assay (VENTANA, 740–4859), and anti-PD-1 antibody (MXB Biotechnologies, MAB-0743) using an automated slide stainer (BenchMark XT, VENTANA Medical Systems, Tucson, AZ, USA), the antibodies were directly added into the stainer without dilution.. The tissue sections were screened at low magnification (× 100) and measured at × 400 magnification.
8
PD-L1 Expression in Invasive Ductal Carcinoma
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PD-L1-expressing tumor-infiltrating immune cells covering ≥ 1% tumor area of invasive ductal carcinoma (IDC) were considered positive for PD-L1 expression, independent of the staining intensity. Samples stained within the > 0–1% interval were considered as borderline, whereas those with a percentage of 0% as negative. The 1% threshold was selected for its clinical significance in the selection of candidates for ICIs. Scoring was performed according to the VENTANA PD-L1 (SP142) assay interpretation guide.
9
PD-L1 Immunohistochemical Staining Evaluation
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All the slides were incubated in di-amino-benzindine (DAB) and counterstained with hematoxylin, dehydrated and mounted. Two independent experienced readers examined the slides and evaluated the percentage and intensity of epithelial and immune stained cells.
PD-L1 positive epithelial cells were defined as having a clear peripheral membrane staining according to the scoring already used in lung cancer clinical trials. Cytoplasmic staining was not considered as positive (Fig.1 ).
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PD-L1 positive epithelial cells were defined as having a clear peripheral membrane staining according to the scoring already used in lung cancer clinical trials. Cytoplasmic staining was not considered as positive (Fig.
PD-L1 Thymoma staining comparaison. Commercial Assays (CA): PDL1 22C3 PharmDx Dako (
10
Evaluating PD-L1 Biomarker Testing
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We evaluated PD-L1 testing information for all eligible patients, including the IHC assay type and the distribution of PD-L1 tumor expression by IHC assay type. The assays included were three FDA-approved IHC assays (Agilent 22C3 pharmDx, Agilent 28–8 pharmDx, Ventana PD-L1 SP142 assay) and all LDTs pooled (including Ventana SP263). We defined the test date as the results date, and PD-L1 tumor expression as the percentage of tumor cells staining for PD-L1. At the time of the study, the database did not capture results for immune cell staining seen with the SP142 assay. Patients could have more than one PD-L1 test and/or assay type.
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