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176 Rucaparib maintenance treatment in patients (Pts) with newly diagnosed ovarian cancer (OC): defining benefit according to disease risk subgroups within the phase 3 ATHENA-MONO study
  1. Domenica Lorusso1,
  2. Rebecca S Kristeleit2,
  3. David M O’Malley3,
  4. Myong Cheol Lim4,
  5. Roshan Agarwal5,
  6. Thomas J Herzog6,
  7. Michelle K Wilson7,
  8. Ana Oaknin8,
  9. Robert L Coleman9,
  10. Amit Oza10,
  11. Olga Mikheeva11,
  12. Larry J Copeland3,
  13. Fatih Köse12,
  14. Andrea Jewell13,
  15. Anita Chudecka-Glaz14,
  16. Marcia L Craib15,
  17. Christy L Connor15,
  18. Danny Shih15,
  19. Keiichi Fujiwara16 and
  20. Bradley J Monk17
  1. 1Dipartimento Scienze della Salute della Donna, del Bambino e di Sanita` Pubblica, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
  2. 2Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  3. 3Division of Gynecologic Oncology, The Ohio State University, James Cancer Center, Cfolumbus, USA
  4. 4Center 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
  5. 5University Hospitals of Northamptonshire, Northampton, UK
  6. 6GOG Foundation and University of Cincinnati College of Medicine, Cincinnati, USA
  7. 7Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand
  8. 8Gynaecologic Cancer Programme; Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  9. 9GOG Foundation and Texas Oncology, The Woodlands, USA
  10. 10Division of Medical Oncology and Hematology, Cancer Clinical Research Unit at Princess Margaret Cancer Centre, Ontario, Toronto, Canada
  11. 11Limited Liability Company MedPomosch, Saint Petersburg, Russia
  12. 12Department of Medical Oncology, Baskent University Faculty of Medicine, Adana, Türkiye
  13. 13Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Kansas Medical Center, Kansas City, USA
  14. 14Department of Surgical Gynecology and Gynecologic Oncology for Adults and Girls, Independent Public Clinical Hospital No. 2 PUM, Szczecin, Poland
  15. 15pharmaand, New York City, USA
  16. 16Saitama Medical University, Saitama, Japan
  17. 17GOG Foundation, HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University, Phoenix, USA


Introduction/Background In ATHENA-MONO (GOG-3020/ENGOT-ov45; NCT03522246), progression-free survival (PFS) improvement was observed with first-line (1L) rucaparib maintenance treatment vs placebo in pts with advanced OC, regardless of molecular characteristics (median PFS, 20.2 vs 9.2 months, log-rank P<.0001; HR, 0.52; 95% CI, 0.40–0.68). Pts with or without high-risk clinical characteristics for disease progression were enrolled in ATHENA-MONO. In the subgroup analyses presented here, we sought to evaluate if all pts benefited from rucaparib 1L maintenance treatment, including those with more favourable prognostic factors at baseline.

Methodology Pts with high-grade, FIGO stage III-IV OC who had completed cytoreductive surgery and 4–8 cycles of 1L platinum-doublet chemotherapy with a response (partial [PR] or complete [CR]) were randomised 4:1 to oral rucaparib 600 mg BID or placebo. Investigator-assessed PFS was evaluated in pt subgroups based on FIGO stage, timing of surgery, and disease status post-chemotherapy.

Results As of 23 March 2022 (data cutoff), 427 and 111 pts were randomised to rucaparib monotherapy vs placebo. The majority of pts had FIGO stage III disease (75%); approximately half underwent primary surgery (49%) and most had no residual disease post-chemotherapy (75%). In the intent-to-treat (ITT) population, investigator-assessed PFS was improved with rucaparib vs placebo across all subgroups based on FIGO stage, timing of surgery, and residual disease (table 1).

Conclusion In the ITT population, 1L rucaparib maintenance treatment improved PFS vs placebo across subgroups regardless of timing of surgery or prognostic disease characteristics, including FIGO stage or residual disease. These results confirm a new maintenance treatment option for OC pts with or without high risk factors for progression at baseline irrespective of molecular characteristics.

Disclosures Per COI.

Abstract 176 Table 1

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