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PO009/#424  Innovative academic homologous recombination deficiency tests available in advanced ovarian cancer: the European ENGOT initiative
  1. Eric Pujade-Lauraine1,
  2. Yann Christinat2,
  3. Maurizio D’Incalci3,
  4. Philip C Schouten4,
  5. Adrien Buisson5,
  6. Lukas C Heukamp6,
  7. Liselore Loverix7,
  8. Celine Callens8,
  9. Raphael Leman9,
  10. Thomas A Mckee2,
  11. Sergio Marchini10,
  12. Eric Hahnen11,
  13. Pierre Saintigny12,
  14. Elena Ioana Braicu13,
  15. Toon Van Gorp14,
  16. Elisa Yaniz-Galende15,
  17. Marc-Henri Stern16,
  18. Dominique Vaur9 and
  19. Isabelle Ray-Coquard17
  1. 1ARCAGY-GINECO, and Gineco, Paris, France
  2. 2Geneva University Hospitals and SAKK, Diagnostic Department, Division of Clinical Pathology, Geneva, Switzerland
  3. 3Humanitas University Laboratory of Cancer Pharmacology, Humanitas Research Hospital Humanitas University and MANGO, Department of Biomedical Science, Pieve Emanuele (MI), Italy
  4. 4Netherlands Cancer Institute and AGO, Department of Molecular Pathology, Amsterdam, Netherlands
  5. 5Centre Léon Bérard and GINECO, Department of Biopathology, Lyon, France
  6. 6Institute for Hämatopathologie Hamburg and NOGGO, Department of Molecular Pathology, Solid Tumors, Hamburg, Germany
  7. 7University Hospitals Leuven Leuven Cancer Institute, KULeuven and BGOG, Division of Gynaecological Oncology, Leuven, Belgium
  8. 8Institut Curie and Paris Sciences Lettres University, Service De Génétique, Paris, France
  9. 9Centre François Baclesse and GINECO, Laboratoire De Biologie Et De Génétique Du Cancer, Fhu-g4 Génomique-u125-plateforme Sesame, Caen, France
  10. 10Humanitas Research Hospital Humanitas University Campus and MANGO, Laboratory of Cancer Pharmacology, Pieve Emanuele (MI), Italy
  11. 11Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne and AGO, Center for Familial Breast and Ovarian Cancer, Cologne, Germany
  12. 12Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286 and GINECO, Department of Medical Oncology, Centre Léon Bérard, Centre De Recherche En Cancérologie De Lyon, Lyon, France
  13. 13Charité, Universitätsmedizin Berlin and NOGGO, Corporate Member of Freie Universität Berlin, Humboldt-universität Zu Berlin, and Berlin Institute of Health. Department of Gynecology, With Center for Oncological Surgery, Campus Virchow Clinic, Berlin, Germany
  14. 14University Hospitals Leuven Leuven Cancer Institute, KULeuven, Division of Gynaecological Oncology, Leuven, Belgium
  15. 15University Paris Saclay and GINECO, Gustave Roussy Et Insermu981, Villejuif, France
  16. 16Institut Curie, D.r.u.m. Team, Inserm U830, Paris, France
  17. 17Centre Léon Bérard and GUINECO, 28 Prom. Léa Et Napoléon Bullukian, and University Claude Bernard Lyon, Lyon, France


Introduction Recently the PAOLA-1/ENGOT-ov25 phase-3 study (Ray-Coquard ESMO-2022) showed that the addition of olaparib maintenance to 1st-line platinum-based therapy and bevacizumab improved survival of advanced ovarian cancer (AOC) patients with HRD positive tumors independently of BRCA status (Myriad myChoice test). The aim of the European ENGOT initiative was to evaluate various academic HRD assays on PAOLA-1 tumor samples.

Methods The novel HRD tests were initially assessed on 85 samples from PAOLA-1 BRCA-wild-type patients and results were correlated with Myriad test. Subsequently, >350 PAOLA-1 samples selected on the basis of tumor DNA availability were tested. Statistics were performed independently (v26.0-SPSS). The ability of each test to predict 1st-line olaparib maintenance efficacy versus placebo was evaluated on PAOLA-1 patient progression-free survival according to HRD/BRCA status.

Results From 12/2019 to 09/2022 a total of 8 European academic laboratories representing 6 countries completed the clinical validation process on the PAOLA-1 samples. Despite the variety of methodological approaches and some differences in the distribution of HRD status, all of tests were clinically validated (table 1) and did not differ significantly from Myriad test results. Progression-free survival hazard ratio between olaparib and placebo arms depending on the assay was between 0.30 and 0.50 for HRD positive patients and between 0.88 and 1.15 for HRD negative patients.

Abstract PO009/#424 Table 1

HRD clinically validated tests from 8 academic laboratories and the reference myChoice Myriad HRD test

Conclusion/Implications The ENGOT HRD initiative is a unique collaboration of European academic laboratories involved in gynaecology oncology translational research. A total of 8 innovative HRD tests achieved a clinical validation from AOC tumor samples of the phase 3 PAOLA-1 study.

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