Teh-Ying Chou, MD, PhD, MBA...PD-L1 immunohistochemistry as a biomarker Presented By Keith Kerr at...
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Biomarkers: PD-L1
ESMO Preceptorship, Immuno-Oncology
November 26, 2018 Singapore
Teh-Ying Chou, MD, PhD, MBA
Chair, Department of Pathology & Lab Medicine
Taipei Veterans General Hospital, TAIWAN
Professor, Institute of Clinical Medicine
National Yang-Ming University, TAIWAN
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Relationships with commercial interests:Advisory Board : Astra Zeneca, Merck Sharp & Dohme, Novartis, RocheHonoraria : Astra Zeneca, Merck Sharp & Dohme, Novartis, Roche
DISCLOSURE
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Cancer Immunotherapy
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Standard of Care for Advanced NSCLC
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Immune Checkpoint Inhibitor anti-PD-1/PD-L1
ICPI
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Biomarkers
• Prognostic Marker
– Single trait or signature of traits that identifies
different groups of patients with respect to the
risk of an outcome of interest in the absence of
treatment
• Predictive Marker
– Single trait or signature of traits that identifies
different groups of patients with respect to the
risk of an outcome of interest in response to a
specific treatment
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Peters S et al
WCLC 2016
ICPI
PD-L1
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PD-L1 immunohistochemistry as a biomarker
Presented By Keith Kerr at 2015 ASCO Annual Meeting
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Immune Biomarker Considerations
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• Epitope stability• Distribution (patchy vs diffuse)• Different antibodies and platforms• Different thresholds for expression• Inter-observer readability
Technical: Assay 1,2
• Inter- and intra-tumour heterogeneity• Inducible and dynamic• Cell type (immune cell vs tumour vs
both)• Location (membrane vs cytoplasm)
Biological: Biomarkers 2,5-8
Immune Biomarker
Considerations
• Interval between tissue and treatment (archived vs fresh)
• Biopsy obtained from primary vs metastatic disease site
• Some circumstances not favorable to obtaining any tissue
• Certain biopsy methods result in poor tissue quality/quantity
• Core needle biopsy • Fine needle aspiration biopsy• Liquid biopsy
Logistical: Tissue 3,4
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PD-L1 Tumor Heterogeneity
McLaughlin et al, JAMA Oncol., 2016.
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H&E PD-L1 (SP142)
PD-L1 Tumor Heterogeneity
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PD-L1 (SP142)
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Atezolizumab Nivolumab Pembrolizumab
Detectionantibody*
SP142 28-8 22C3
IHC platform Ventana Dako Dako
Tested cellsNSCLC (IC and TC)
UC (IC)Lung (TC)
NSCLC (TC)UC (TC and stroma)
Estimated PD-L1prevalence in NSCLC
Predictive value?
TC1/2/3 & IC1/2/3‡
26%
IC1/2/3 & TC0*
30%
TC1/2/3 & IC0*
11%
PD-L1+ as ≥50% of TCs
~46%1
PD-L1+ as ≥5% of TCs
~25%1
*TC3 or IC3 = TC ≥ 50% or IC ≥ 10% PD-L1+; TC2/3 or IC2/3 = TC or IC ≥ 5% PD-L1+; TC1/2/3 or IC1/2/3 = TC or IC ≥ 1% PD-L1+; TC0 and IC0 = TC and IC < 1% PD-L1+, respectively.‡POPLAR (Spira, et al. ASCO 2015); Study-003 (Brahmer, et al. ASCO 2014; KEYNOTE-001 (Garon, et al. AACR 2015)1. Kerr KM, et al. J Thorac Oncol 2015
PD-L1 expression correlates with efficacy
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Approved and Investigational PD-L1 Diagnostics in NSCLC
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Nivolumab 1: BMS
Pembrolizumab 2: Merck
Atezolizumab 3: Roche
Durvalumab 4: AstraZeneca
Ab Clone 28-8 SP263 22C3 SP142 SP263
Diagnostic Partner Dako5 Ventana6 Dako7 Ventana8 Ventana4
Scoring Method † % of PD-L1–expressing tumour cells
% of PD-L1–expressing tumour
cells
% of PD-L1–expressing tumour
cells or immune cells
% of PD-L1–expressing tumour
cells
Diagnostic Status
Complementary:
testing not required
Companion:
testing required
US/EU: SQ and NSQ
NSCLC
Dx not approved for
NSCLC setting
Dx not approved for
durvalumab in any
settingUS/EU:
NSQ NSCLC
EU:
NSQ NSCLC
Approved IVD
PD-L1 Threshold
US/EU:
All patients
eligible
EU:
All patients eligible
US: ≥50%
EU: ≥1%NA NA
Validated PD-L1
Thresholds≥1%, ≥5%, or ≥10% ≥1%, ≥50% NA NA
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Different Classes of In Vitro Diagnostics
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IVDs vs LDTs
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Practical Considerations for PD-L1 Testing
• Formal HTA Assessment of PD-L1 Dx Test Is Not Required in Most Markets
Class III In Vitro Diagnostics 1,2
Developed in the form of a kit for general use
FDA approval of kits
requiredCE marking required
Highly regulated PMA
process before being
marketed
Clinical safety or
performance evaluation
required
Laboratory-Developed Tests 1,2
Created by local laboratories, at which use
is restricted
Created by local laboratories
No requirement for
premarket review, plans
in place for future
No requirement for
premarket review,
manufacturer self-
declares
Clinical validation is not
required for their use
Clinical safety or
performance evaluation
required
CE = Conformité Européene (European Conformity); Dx = diagnostic; HER2 = human epidermal growth factor receptor 2; HTA = health technology assessment; IVDs = in vitro diagnostics; LDTs = laboratory-developed tests; PMA = premarket approval.
1. In Vitro Companion Diagnostic Devices. FDA Guidance. August 6, 2014. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262327.pdf. Accessed September 2016. 2. Understanding Europe’s New Medical Devices Regulation (MDR). Key changes contained in the proposed MDR and their impact on manufacturers. EMERGO white paper: July 2016, anticipated publishing date early 2017.
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PD-L1 Assay Analytic Comparability: The Blueprint Project
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Reference Area Footnotes Area
• The Blueprint project identifies four in vitro diagnostics (IVDs) for PD-L1 testing where results can be compared:
• The objective of the Blueprint project is to evaluate the analytical comparability of the four PD-L1 assays with 39 NSCLC samples
– The interchangeable use of PD-L1 assays will also be assessed
• AACR, IASLC, and four pharmaceutical companies collaborated in the design and implementation of this project
Abcam 28-8 mAb Dako 22C3 mAb Spring Bioscience
SP142 mAb
Spring Bioscience
SP263 mAb
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Blueprint Project: Study Design
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• Two-phase study to gain sufficient data and rigor:
Phase 1Phase 1
Feasibility on small cohort evaluated at Dako and V entanaTo assess the four PD-L1 diagnostics on the same NSCLC cases and gather initial data in two stages:
• Step 1: Evaluate analytical comparability by quantifying and comparing PD-L1 expression on tumour and immune cells
• Step 2: Clinical agreement was assessed through comparisons of patient classification and agreement using various combinations of assays and PD-L1 staining thresholds
Feasibility on small cohort evaluated at Dako and V entanaTo assess the four PD-L1 diagnostics on the same NSCLC cases and gather initial data in two stages:
• Step 1: Evaluate analytical comparability by quantifying and comparing PD-L1 expression on tumour and immune cells
• Step 2: Clinical agreement was assessed through comparisons of patient classification and agreement using various combinations of assays and PD-L1 staining thresholds
Phase 2Phase 2 TBD: Proposed larger, statistically powered study that will be designed from the Phase 1 “information gathering”TBD: Proposed larger, statistically powered study that will be designed from the Phase 1 “information gathering”
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Agreement Between Assays For PD-L1 Expression
Based on Specified Cutoffs (N=38 cases)
Nineteen (19) cases (blue circle) show agreement with all four assays above
selected cut-off regardless of which matched assay cutoff is employed
Overlapping cases < all specified cutoffs (N=5) are not shown
AGREEMENT all assays: 24/38 ( 63%)
SP142 TC1/IC1
(30/38)
28-8 1% TPS
(26/38)
22C3 1% TPS
(26/38)
SP263 25%
(20/38)
Hirsch FR et al. J Thorac Oncol 2017
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Hirsch FR WCLC 2017
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Reliability of Scoring PD-L1 on Tumor Cells
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Take Home MessageBlue print Phase 2 study
• The feasibility of harmonizing the clinical use of 5 trial-validated PD-L1 IHC
assays (28-8, 22C3, SP263, SP142 & 73-10) are assessed by 24 international
expert pulmonary pathologists.
• Glass slides and digital images for tissue and cytology samples are applied.
• The results show highly comparable staining by 3 assays, less sensitivity by
SP142 and higher sensitivity by 73-10.
• Scoring by glass slides and digital images are highly concordant.
• Very strong reliability among pathologists in scoring TC, poor reliability in
scoring IC, and moderate agreement in sections of needle aspirate cell
blocks are observed.
• Evidence for interchangeability among 3 PD-L1 IHC assays is consolidated.
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IASLC Atlas of PD-L1 IHC in Lung Cancer
Analytical versus Clinical Comparison/Compatibility !!!
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Figure 1
Journal of Thoracic Oncology 2018 13, 447-453DOI: (10.1016/j.jtho.2017.10.034) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions
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PD-L1 Expression in CTC
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Take Home Messages
• PD-L1 has been the seminal predictive marker for anti-PD-
1/PD-L1 immunotherapy
• Companion versus Complimentary PD-L1 testing is generally
based on clinical trials
• The use of IVD versus LDT depends on regional regulations
(and financial indications)
• The PD-L1 IHC of tumor cells has high scoring concordance
among 22C3, 28-8 and SP263 platforms using FFPE tissue
• The PD-L1 IHC on cytology specimens and circulating tumor
cells may be promising, as well as evaluating soluble PD-1/PD-
L1 and the post-translational modifications of PD-L1
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Have a Nice Day!AcknowledgementYi-Chen Yeh, MD
Hsiang-Ling Ho, PhD