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  • #1120 Durvalumab with paclitaxel/carboplatin + bevacizumab then maintenance durvalumab, bevacizumab + olaparib in patients with newly diagnosed advanced ovarian cancer without a tumour BRCA1/2 mutation: results from the DUO-O/ENGOT-Ov46/AGO-OVAR 23/GOG-3…

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Late Breaking Abstracts
06. Ovarian cancer
#1120 Durvalumab with paclitaxel/carboplatin + bevacizumab then maintenance durvalumab, bevacizumab + olaparib in patients with newly diagnosed advanced ovarian cancer without a tumour BRCA1/2 mutation: results from the DUO-O/ENGOT-Ov46/AGO-OVAR 23/GOG-3025 trial
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  1. Christian Marth1,
  2. Tjoung-Won Park-Simon2,
  3. Carol Aghajanian3,
  4. Alexander Reuss4,
  5. Shin Nishio5,
  6. Myong Cheol Lim6,
  7. Maria Jesús Rubio-Pérez7,
  8. Mehmet Ali Vardar8,
  9. Giovanni Scambia9,
  10. Renaud Sabatier10,
  11. Charlotte Haslund11,
  12. Nicoletta Colombo12,
  13. Anita Chudecka-Glaz13,
  14. Stephanie Lheureux14,
  15. Greet Huygh15,
  16. Fabienne Schochter16,
  17. Robert M Wenham17,
  18. Aikou Okamoto18,
  19. Emily Day19 and
  20. Philipp Harter20
  1. 1Medical University Innsbruck, and AGO-Au, Innsbruck, Austria
  2. 2Department of Gyncecology and Obstetrics, Medizinische Hochschule Hannover, and AGO, Hannover, Germany
  3. 3Memorial Sloan Kettering Cancer Center, and GOG-F, New York, USA
  4. 4Co-ordinating Center for Clinical Trials of the Philipps-University of Marburg, and ENGOT, Marburg, Germany
  5. 5Department of Obstetrics and Gynecology, Kurume University School of Medicine, and JGOG, Kurume, Japan
  6. 6Center for Gynecologic Cancer; Rare and Pediatric Cancer Branch and Immuno-oncology Branch, Research Institute; Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, and KGOG, Goyang, South Korea
  7. 7Reina Sofia University Hospital, and GEICO, Cordoba, Spain
  8. 8Medical Faculty, Department of Obstetrics and Gynecology, University of Cukurova, and Department of Gynecologic Oncology, Balcali Hospital, and TRSGO, Adana, Turkey
  9. 9Fondazione Policlinico Universitario A. Gemelli IRCCS, and MITO, Rome, Italy
  10. 10Aix-Marseille Univ, CRCM, Inserm, CNRS, Institut Paoli-Calmettes, Department of Medical Oncology, Marseille Medical Oncology Department, Institut Paoli Calmettes, and GINECO, Marseille, France
  11. 11Department of Oncology, Aalborg University Hospital, and NSGO, Aalborg, Denmark
  12. 12University of Milan-Bicocca and Istituto Europeo di Oncologia IRCCS, and MANGO, Milan, Italy
  13. 13Department of Gynecological Surgery and Gynecological Oncology of Adults and Adolescents, SPSK Nr 2, Pomeranian Medical University, and PGOG, Szczecin, Poland
  14. 14Princess Margaret Hospital, Department of Medical Oncology, and PMHC, Toronto, Canada
  15. 15Onze-Lieve-Vrouwziekenhuis Aalst Campus Aalst Moorselbaan, and BGOG, Aalst, Belgium
  16. 16Universitätsfrauenklinik Prittwitzstr, and AGO, Ulm, Germany
  17. 17Moffitt Cancer Center, Department of Gynecologic Oncology, and GOG-F, Tampa, USA
  18. 18Department of Obstetrics and Gynecology, The Jikei University School of Medicine, and JGOG, Tokyo, Japan
  19. 19Oncology Biometrics, Oncology RandD, AstraZeneca, Cambridge, UK
  20. 20Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, and AGO, Essen, Germany

Abstract

Introduction/Background Olaparib maintenance improved outcomes in patients with newly diagnosed advanced ovarian cancer (AOC) and a BRCAm (DiSilvestro JCO 2023), or with bevacizumab in patients with homologous recombination deficiency (HRD+) tumours (Ray-Coquard ESMO 2022) in response to first-line treatment; however, an unmet need remains.

Methodology In the randomised Phase III DUO-O trial (NCT03737643), patients had newly diagnosed high-grade epithelial non-tumour (t) BRCAm AOC; primary, or planned interval, debulking surgery; and one cycle of paclitaxel/carboplatin +/– bevacizumab. At Cycle 2, patients were randomised 1:1:1 to Arm 1: paclitaxel/carboplatin + bevacizumab + placebo (up to six cycles) then maintenance bevacizumab (total 15 months) + placebos (total 24 months); Arm 2: paclitaxel/carboplatin + bevacizumab + durvalumab then maintenance bevacizumab + durvalumab + placebo; or Arm 3: paclitaxel/carboplatin + bevacizumab + durvalumab then maintenance bevacizumab + durvalumab + olaparib. Progression free survival (PFS) in Arm 3 versus Arm 1 (primary endpoint) was tested in the non-tBRCAm HRD+ then the intent-to-treat (ITT) populations.

Results At a prespecified interim analysis, Arm 3 demonstrated a statistically significant PFS improvement versus Arm 1: HR 0.49 (95% CI 0.34–0.69; P<0.0001) and HR 0.63 (95% CI 0.52–0.76; P<0.0001) in the HRD+ and ITT populations, respectively; a PFS effect was observed in the HRD– subgroup (HR 0.68 [95% CI 0.54–0.86]). A numerical, but not statistically significant, PFS improvement was shown for Arm 2 versus Arm 1 (ITT population) (table 1). During the study, any serious AEs were reported in 34%, 43% and 39% of patients in Arms 1, 2 and 3, respectively.

View this table:
Abstract #1120 Table 1

Conclusion Paclitaxel/carboplatin + bevacizumab + durvalumab followed by maintenance bevacizumab + durvalumab + olaparib in patients with newly diagnosed non-tBRCAm AOC demonstrated a statistically significant and clinically meaningful improvement in PFS versus paclitaxel/carboplatin + bevacizumab followed by maintenance bevacizumab. Safety was generally consistent with the known profiles of each agent.

Disclosures © 2023 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO Annual Meeting. All rights reserved.

This study was sponsored by AstraZeneca.

https://doi.org/10.1136/ijgc-2023-ESGO.899

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