Pan-tumor validation of a NGS fraction-based MSI analysis as a predictor of response to Pembrolizumab

  1. Lin, Douglas ORCID logo
  2. Quintanilha, Julia C. F.
  3. Danziger, Natalie ORCID logo
  4. Lang, Lixin
  5. Levitan, Diane
  6. Hayne, Cynthia
  7. Hiemenz, Matthew C.
  8. Smith, David L.
  9. Albacker, Lee ORCID logo
  10. Leibowitz, Jeffrey
  11. Mata, Douglas ORCID logo
  12. Decker, Brennan
  13. Lakis, Sotirios
  14. Patel, Nimesh R. ORCID logo
  15. Graf, Ryon P.
  16. Elvin, Julia A.
  17. Ross, Jeffrey S.
  18. Pattani, Varun
  19. Huang, richard ORCID logo
  20. Wehn, Amy K.

Download
41698_2024_Article_679.pdf 1,50MB
WeightNameValue
1000 Titel
  • Pan-tumor validation of a NGS fraction-based MSI analysis as a predictor of response to Pembrolizumab
1000 Autor/in
  1. Lin, Douglas |
  2. Quintanilha, Julia C. F. |
  3. Danziger, Natalie |
  4. Lang, Lixin |
  5. Levitan, Diane |
  6. Hayne, Cynthia |
  7. Hiemenz, Matthew C. |
  8. Smith, David L. |
  9. Albacker, Lee |
  10. Leibowitz, Jeffrey |
  11. Mata, Douglas |
  12. Decker, Brennan |
  13. Lakis, Sotirios |
  14. Patel, Nimesh R. |
  15. Graf, Ryon P. |
  16. Elvin, Julia A. |
  17. Ross, Jeffrey S. |
  18. Pattani, Varun |
  19. Huang, richard |
  20. Wehn, Amy K. |
1000 Verlag
  • Nature Publishing Group UK
1000 Erscheinungsjahr 2024
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2024-09-14
1000 Erschienen in
1000 Quellenangabe
  • 8(1):204
1000 Copyrightjahr
  • 2024
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1038/s41698-024-00679-7 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11401835/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Microsatellite instability high (MSI-H) and mismatch repair deficient (dMMR) tumor status have been demonstrated to predict patient response to immunotherapies. We developed and validated a next-generation sequencing (NGS)-based companion diagnostic (CDx) to detect MSI-H solid tumors via a comprehensive genomic profiling (CGP) assay, FoundationOne®CDx (F1CDx). To determine MSI status, F1CDx calculates the fraction of unstable microsatellite loci across >2000 loci using a fraction-based (FB) analysis. Across solid tumor types, F1CDx demonstrated a high analytical concordance with both PCR (n = 264) and IHC (n = 279) with an overall percent agreement (OPA) of 97.7% and 97.8%, respectively. As part of a retrospective bridging clinical study from KEYNOTE-158 Cohort K and KEYNOTE-164, patients with MSI-H tumors as determined by F1CDx demonstrated an objective response rate (ORR) of 43.0% to pembrolizumab. In real-world cancer patients from a deidentified clinicogenomic database, F1CDx was at least equivalent in assessing clinical outcome following immunotherapy compared with MMR IHC. Demonstrated analytical and clinical performance of F1CDx led to the pan-tumor FDA approval in 2022 of F1CDx to identify MSI-H solid tumor patients for treatment with pembrolizumab. F1CDx is an accurate, reliable, and FDA-approved method for the identification of MSI-H tumors for treatment with pembrolizumab.
1000 Sacherschließung
lokal /631/67/69
lokal Article
lokal /692/53/2423
lokal /692/4017
lokal article
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0003-0105-9760|https://frl.publisso.de/adhoc/uri/UXVpbnRhbmlsaGEsIEp1bGlhIEMuIEYu|https://orcid.org/0000-0003-2642-7160|https://frl.publisso.de/adhoc/uri/TGFuZywgTGl4aW4=|https://frl.publisso.de/adhoc/uri/TGV2aXRhbiwgRGlhbmU=|https://frl.publisso.de/adhoc/uri/SGF5bmUsIEN5bnRoaWE=|https://frl.publisso.de/adhoc/uri/SGllbWVueiwgTWF0dGhldyBDLg==|https://frl.publisso.de/adhoc/uri/U21pdGgsIERhdmlkIEwu|https://orcid.org/0000-0002-5070-1783|https://frl.publisso.de/adhoc/uri/TGVpYm93aXR6LCBKZWZmcmV5|https://orcid.org/0000-0002-8059-8668|https://frl.publisso.de/adhoc/uri/RGVja2VyLCBCcmVubmFu|https://frl.publisso.de/adhoc/uri/TGFraXMsIFNvdGlyaW9z|https://orcid.org/0000-0001-6013-5562|https://frl.publisso.de/adhoc/uri/R3JhZiwgUnlvbiBQLg==|https://frl.publisso.de/adhoc/uri/RWx2aW4sIEp1bGlhIEEu|https://frl.publisso.de/adhoc/uri/Um9zcywgSmVmZnJleSBTLg==|https://frl.publisso.de/adhoc/uri/UGF0dGFuaSwgVmFydW4=|https://orcid.org/0000-0001-8395-5168|https://frl.publisso.de/adhoc/uri/V2VobiwgQW15IEsu
1000 Hinweis
  • DeepGreen-ID: 98463af19a6540fea78a35051fbda521 ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search)
1000 Label
1000 Dateien
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6523878.rdf
1000 Erstellt am 2025-07-07T00:37:58.115+0200
1000 Erstellt von 322
1000 beschreibt frl:6523878
1000 Zuletzt bearbeitet 2025-07-29T22:19:12.835+0200
1000 Objekt bearb. Tue Jul 29 22:19:12 CEST 2025
1000 Vgl. frl:6523878
1000 Oai Id
  1. oai:frl.publisso.de:frl:6523878 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

View source