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LB008/#180  KGOG3056/Nirvana-R trial: efficacy of maintenance niraparib rechallenge plus BEV according to minimal residual disease (MRD) assessment in patients with platinum-sensitive, recurrent ovarian cancer previously treated with a PARP inhibitor
  1. Hyun-Woong Cho1,
  2. Jeong-Yeol Park2,
  3. Myong Cheol Lim3,
  4. Byoung-Gie Kim4,
  5. Min Chul Choi5,
  6. Jae-Weon Kim6,
  7. Dae Hoon Jeong7 and
  8. Jung-Yun Lee8
  1. 1Korea University Guro Hospital, Seoul, Korea, Republic of
  2. 2Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  3. 3National Cancer Center, Goyang, Korea, Republic of
  4. 4Samsung medical center, Seoul, Korea, Republic of
  5. 5CHA Bundang Medical Center, Seoul, Korea, Republic of
  6. 6Seoul National University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Busan Paik Hospital, Inje University, Obstetrics & Gynecology, Busan, Korea, Republic of
  8. 8Yonsei University College of Medicine, Gynecologic Cancer Center, Seoul, Korea, Republic of

Abstract

Introduction Given the expanding clinical use of PARP inhibitor, there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi.

Methods This is a multi-center, single-arm, phase 2 study (NCT04734665) evaluating niraparib and bevacizumab maintenance in patients with platinum-sensitive recurrent ovarian cancer (PSROC) who received at least 2 prior platinum-containing therapy and had been treated with a PARPi. Patients who had responded to the last platinum regimen were eligible to participate in this study. The primary endpoint is a 6-month progression-free survival (PFS) rate. A total of forty-four patients were recruited. Minimal residual disease (MRD) status from baseline circulating tumor DNA (ctDNA) were assessed by whole-exome sequencing.

Results Most of the patients (93.2%) had high-grade serous carcinoma. After interim analysis of the first stage, the efficacy boundary to proceed to the second stage was met (6-month PFS rate 66.5%). We will report efficacy outcomes from the primary analysis (date cutoff June 2024), including 6-month PFS rate, PFS, and OS, in the overall population. A table will provide detail of results according to MRD status, BRCA status, platinum-free interval, and response of latest chemotherapy. Adverse events (AEs), dose modifications, and discontinuations will be reported. Genomic mechanisms of PARPi resistance will be reported.

Conclusion/Implications This is the first report of niraparib and bevacizumab as a maintenance therapy in PSROC patients previously treated with a PARPi. This study is expected to demonstrate that doublet maintenance is a potential new treatment option for patients previously treated with a PARPi.

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