Publication

Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer

Schatz, S., Falk, M., Jóri, B., Ramdani, H. O., Schmidt, S., Willing, E-M., Menon, R., Groen, H. J. M., Diehl, L., Kröger, M., Wesseler, C., Griesinger, F., Hoffknecht, P., Tiemann, M. & Heukamp, L. C., 24-Jun-2020, In : Cancers. 12, 6, 14 p., 1685.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Schatz, S., Falk, M., Jóri, B., Ramdani, H. O., Schmidt, S., Willing, E-M., ... Heukamp, L. C. (2020). Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer. Cancers, 12(6), [1685]. https://doi.org/10.3390/cancers12061685

Author

Schatz, Stefanie ; Falk, Markus ; Jóri, Balázs ; Ramdani, Hayat O ; Schmidt, Stefanie ; Willing, Eva-Maria ; Menon, Roopika ; Groen, Harry J M ; Diehl, Linda ; Kröger, Matthias ; Wesseler, Claas ; Griesinger, Frank ; Hoffknecht, Petra ; Tiemann, Markus ; Heukamp, Lukas C. / Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer. In: Cancers. 2020 ; Vol. 12, No. 6.

Harvard

Schatz, S, Falk, M, Jóri, B, Ramdani, HO, Schmidt, S, Willing, E-M, Menon, R, Groen, HJM, Diehl, L, Kröger, M, Wesseler, C, Griesinger, F, Hoffknecht, P, Tiemann, M & Heukamp, LC 2020, 'Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer', Cancers, vol. 12, no. 6, 1685. https://doi.org/10.3390/cancers12061685

Standard

Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer. / Schatz, Stefanie; Falk, Markus; Jóri, Balázs; Ramdani, Hayat O; Schmidt, Stefanie; Willing, Eva-Maria; Menon, Roopika; Groen, Harry J M; Diehl, Linda; Kröger, Matthias; Wesseler, Claas; Griesinger, Frank; Hoffknecht, Petra; Tiemann, Markus; Heukamp, Lukas C.

In: Cancers, Vol. 12, No. 6, 1685, 24.06.2020.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Schatz S, Falk M, Jóri B, Ramdani HO, Schmidt S, Willing E-M et al. Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer. Cancers. 2020 Jun 24;12(6). 1685. https://doi.org/10.3390/cancers12061685


BibTeX

@article{3f08a1fcfe7c4f779a0f80bf8ce9b9c8,
title = "Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer",
abstract = "In recent years, Non-small cell lung cancer (NSCLC) has evolved into a prime example for precision oncology with multiple FDA-approved {"}precision{"} drugs. For the majority of NSCLC lacking targetable genetic alterations, immune checkpoint inhibition (ICI) has become standard of care in first-line treatment or beyond. PD-L1 tumor expression represents the only approved predictive biomarker for PD-L1/PD-1 checkpoint inhibition by therapeutic antibodies. Since PD-L1-negative or low-expressing tumors may also respond to ICI, additional factors are likely to contribute in addition to PD-L1 expression. Tumor mutation burden (TMB) has emerged as a potential candidate; however, it is the most complex biomarker so far and might represent a challenge for routine diagnostics. We therefore established a hybrid capture (HC) next-generation sequencing (NGS) assay that covers all oncogenic driver alterations as well as TMB and validated TMB values by correlation with the assay (F1CDx) used for the CheckMate 227 study. Results of the first consecutive 417 patients analyzed in a routine clinical setting are presented. Data show that fast reliable comprehensive diagnostics including TMB and targetable alterations are obtained with a short turn-around time. Thus, even complex biomarkers can easily be implemented in routine practice to optimize treatment decisions for advanced NSCLC.",
keywords = "immuno-oncology, tumor mutational burden, lung cancer, routine diagnostics, driver mutation, PD-L1, NIVOLUMAB PLUS IPILIMUMAB, 1ST-LINE TREATMENT, OPEN-LABEL, IMMUNOHISTOCHEMISTRY, NEOANTIGENS, SENSITIVITY, BLOCKADE, EFFICACY, PHASE-1",
author = "Stefanie Schatz and Markus Falk and Bal{\'a}zs J{\'o}ri and Ramdani, {Hayat O} and Stefanie Schmidt and Eva-Maria Willing and Roopika Menon and Groen, {Harry J M} and Linda Diehl and Matthias Kr{\"o}ger and Claas Wesseler and Frank Griesinger and Petra Hoffknecht and Markus Tiemann and Heukamp, {Lukas C}",
year = "2020",
month = "6",
day = "24",
doi = "10.3390/cancers12061685",
language = "English",
volume = "12",
journal = "Cancers",
issn = "2072-6694",
publisher = "MDPI AG",
number = "6",

}

RIS

TY - JOUR

T1 - Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer

AU - Schatz, Stefanie

AU - Falk, Markus

AU - Jóri, Balázs

AU - Ramdani, Hayat O

AU - Schmidt, Stefanie

AU - Willing, Eva-Maria

AU - Menon, Roopika

AU - Groen, Harry J M

AU - Diehl, Linda

AU - Kröger, Matthias

AU - Wesseler, Claas

AU - Griesinger, Frank

AU - Hoffknecht, Petra

AU - Tiemann, Markus

AU - Heukamp, Lukas C

PY - 2020/6/24

Y1 - 2020/6/24

N2 - In recent years, Non-small cell lung cancer (NSCLC) has evolved into a prime example for precision oncology with multiple FDA-approved "precision" drugs. For the majority of NSCLC lacking targetable genetic alterations, immune checkpoint inhibition (ICI) has become standard of care in first-line treatment or beyond. PD-L1 tumor expression represents the only approved predictive biomarker for PD-L1/PD-1 checkpoint inhibition by therapeutic antibodies. Since PD-L1-negative or low-expressing tumors may also respond to ICI, additional factors are likely to contribute in addition to PD-L1 expression. Tumor mutation burden (TMB) has emerged as a potential candidate; however, it is the most complex biomarker so far and might represent a challenge for routine diagnostics. We therefore established a hybrid capture (HC) next-generation sequencing (NGS) assay that covers all oncogenic driver alterations as well as TMB and validated TMB values by correlation with the assay (F1CDx) used for the CheckMate 227 study. Results of the first consecutive 417 patients analyzed in a routine clinical setting are presented. Data show that fast reliable comprehensive diagnostics including TMB and targetable alterations are obtained with a short turn-around time. Thus, even complex biomarkers can easily be implemented in routine practice to optimize treatment decisions for advanced NSCLC.

AB - In recent years, Non-small cell lung cancer (NSCLC) has evolved into a prime example for precision oncology with multiple FDA-approved "precision" drugs. For the majority of NSCLC lacking targetable genetic alterations, immune checkpoint inhibition (ICI) has become standard of care in first-line treatment or beyond. PD-L1 tumor expression represents the only approved predictive biomarker for PD-L1/PD-1 checkpoint inhibition by therapeutic antibodies. Since PD-L1-negative or low-expressing tumors may also respond to ICI, additional factors are likely to contribute in addition to PD-L1 expression. Tumor mutation burden (TMB) has emerged as a potential candidate; however, it is the most complex biomarker so far and might represent a challenge for routine diagnostics. We therefore established a hybrid capture (HC) next-generation sequencing (NGS) assay that covers all oncogenic driver alterations as well as TMB and validated TMB values by correlation with the assay (F1CDx) used for the CheckMate 227 study. Results of the first consecutive 417 patients analyzed in a routine clinical setting are presented. Data show that fast reliable comprehensive diagnostics including TMB and targetable alterations are obtained with a short turn-around time. Thus, even complex biomarkers can easily be implemented in routine practice to optimize treatment decisions for advanced NSCLC.

KW - immuno-oncology

KW - tumor mutational burden

KW - lung cancer

KW - routine diagnostics

KW - driver mutation

KW - PD-L1

KW - NIVOLUMAB PLUS IPILIMUMAB

KW - 1ST-LINE TREATMENT

KW - OPEN-LABEL

KW - IMMUNOHISTOCHEMISTRY

KW - NEOANTIGENS

KW - SENSITIVITY

KW - BLOCKADE

KW - EFFICACY

KW - PHASE-1

U2 - 10.3390/cancers12061685

DO - 10.3390/cancers12061685

M3 - Article

C2 - 32599951

VL - 12

JO - Cancers

JF - Cancers

SN - 2072-6694

IS - 6

M1 - 1685

ER -

ID: 129134032