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2022-RA-873-ESGO Validation study of the ‘NOGGO-GIS ASSAY’ based on ovarian cancer samples from the first-line PAOLA-1/ENGOT-ov25 phase-III trial
  1. Eva-Maria Willing1,
  2. Claudia Vollbrecht2,3,
  3. Christine Voessing1,
  4. Peggy Weist1,
  5. Simon Schallenberg2,
  6. Balazs Jori1,
  7. Markus Tiemann1,
  8. Guillaume Bataillon4,
  9. Philipp Harter5,
  10. Sandro Pignata6,
  11. Antonio Gonzales Martin7,8,
  12. Ignace Vergote9,
  13. Nicoletta Colombo10,
  14. Christian Marth11,
  15. Tobias Berg1,
  16. Bettina Kah1,
  17. Johanna Herbst1,
  18. Trine Jakobi Noettrup12,
  19. Markus Falk1,
  20. Kathrin Arndt1,
  21. Isabelle Ray-Coquard13,14,
  22. Andreas Polten15,
  23. Robert Bernstein1,
  24. Franziska Selzam1,
  25. Judith Pirngruber1,
  26. Stefanie Schmidt1,
  27. Michael Hummel2,3,
  28. Jalid Sehouli16,3,
  29. David Horst2,
  30. Elena Ioana Braicu16,3,14,
  31. Eric Pujade Lauraine14,
  32. Katharina Tiemann1,3 and
  33. Lukas C Heukamp1,3
  1. 1Institut für Hämatopathologie, Hamburg, Germany
  2. 2Institute of Pathology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin and Berlin Institute of Health, Berlin, Germany
  3. 3Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie NOGGO e. V., Berlin, Germany
  4. 4Laboratoire de pathologie de l’oncopole-IUCT, Touluose, France
  5. 5Kliniken Essen Mitte, Essen, Germany
  6. 6Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples, Italy
  7. 7Medical Oncology Departament, Clinica Universidad de Navarra, Madrid, Spain
  8. 8GEICO, Madrid, Spain
  9. 9Leuven Cancer Institute, University Hospital Leuven, Leuven, Belgium
  10. 10European Institute of Oncology, Milan, Italy
  11. 11Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria
  12. 12Copenhagen University Hospital, Copenhagen, Denmark
  13. 13Centre Léon BERARD, and University Claude Bernard Lyon I, Lyon, France
  14. 14ARCAGY-GINECO, Paris, France
  15. 15Agilent Technologies Sales and Services GmbH und Co.KG, Waldbronn, Germany
  16. 16Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin and Berlin Institute of Health, Berlin, Germany


Introduction/Background Several clinical trials have demonstrated that the maintenance with a PARP inhibitor with or without bevacizumab following platinum-based therapy improved PFS in advanced ovarian cancer patients. The benefit was significant greater in homologous recombination deficient (HRD) patients according to Myriad myChoice test. The PAOLA-1 olaparib+bevacizumab maintenance regimen was approved in USA/Europe/Japan for HRD and BRCA positive patients. Using sample from the PAOLA-1/ENGOT-ov25 we evaluated the novel ‘NOGGO-GIS ASSAY’ as part of the ENGOT HRD-European-Initiative.

Methodology A hybrid capture NGS assay based on the Agilent XTH2 chemistry and SNP backbone, was developed for the detection of somatic driver mutations in key cancer genes, BRCA1/2 mutations, HRR gene mutations and HRD in combination with a bioinformatic analysis pipeline based on publicly available tools. The assay was clinically validated using 468 ovarian cancer samples from the PAOLA-1/ENGOT-ov25 trial.

Results Here we report the first results of the ‘NOGGO-GIS ASSAY’ validation compared to the Myriad myChoice clinical trial. The assay is based on widely available hybrid capture chemistry, to cover 57 genes and approx. 20.000 SNP loci, automated for parallel processing of 48 samples per run and requires 50 ng of genomic DNA extracted from tissue section with at least 30% of tumor content with a low failure rate of around 5%. The performance characteristics of the NOGGO GIS Assay are comparable to the PAOLA-1/ENGOT-ov25 clinical trial assay. The NOGGO GIS Assay showed a similar impact of olaparib+bevacizumab on PFS with a comparable Hazard Ratio for HRD positive patients.

Conclusion The ‘NOGGO-GIS ASSAY’ based on widely available components was validated on clinical trial samples showing performance characteristics similar to the clinical trial assay. The low failure rate, low input material required, HRD and BRCA1/2 and mutation status in 57 clinically relevant genes makes this a highly attractive option for analysis of FFPE samples.

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