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  • PR054/#1517  A single-arm, phase II study of niraparib and bevacizumab maintenance in patients with platinum-sensitive, recurrent ovarian cancer previously treated with a PARP inhibitor (KGOG 3056/NIRVANA-R)

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AS11. Ovarian cancer
PR054/#1517  A single-arm, phase II study of niraparib and bevacizumab maintenance in patients with platinum-sensitive, recurrent ovarian cancer previously treated with a PARP inhibitor (KGOG 3056/NIRVANA-R)
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  1. Hyun-Woong Cho1,
  2. Jeong-Yeol Park2,
  3. Byoung Gie Kim3,
  4. Jae-Weon Kim4,
  5. Myong Cheol Lim5,
  6. Min Chul Choi6,
  7. Dae Hoon Jeong7 and
  8. Jung-Yun Lee8
  1. 1Korea University Guro Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  2. 2Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  3. 3Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea, Republic of
  4. 4Seoul National University, Obstetrics and Gynecology, Seoul, Korea, Republic of
  5. 5Center for Gynecologic Cancer, National Cancer Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  6. 6CHA Bundang Medical Center, Comprehensive Gynecologic Cancer Center, Seongnam, Korea, Republic of
  7. 7Busan Paik Hospital, College of Medicine, Inje University, Department of Obstetrics and Gynecology, Busan, Korea, Republic of
  8. 8Yonsei University Health System, Obstetrics and Gynecology, Seoul, Korea, Republic of

Abstract

Introduction The aim of NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARP inhibitor(PARPi).

Methods This study includes patients with platinum-sensitive recurrent ovarian cancer who had received at least two previous courses of platinum-containing therapy and had been treated with a PARPi. Patients who had responded to the last platinum regimen are eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression. The primary endpoint of the study is 6-month progression-free survival (PFS) rate. A Simon 2-stage design is utilized. Target accrual is 22 patients in the first stage; 13 or more patients without progressive disease within 6 months is required to proceed to second stage.

Results We report the results from the first stage. Median age was 56 years old, high grade serous and motst of the patients (90.9%) had high-grade serous carcinoma. Of the 22 patients from the first stage, 9 had progressive disease within 6 months (6-month PFS rate 66.5%, 95% CI 48.9–90.2%). The efficacy boundary to proceed to the second stage was met. No grade 4 or 5 treatment-related adverse events (TREAs) were reported, and no TRAEs leading to treatment discontinuation.

Conclusion/Implications Our findings indicate encouraging safety and activity of niraparib + bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi.

Abstract PR054/#1517 Figure 1
Abstract PR054/#1517 Figure 1

https://doi.org/10.1136/ijgc-2023-IGCS.95

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