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  • PO010/#673  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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Plenary 03: Oral Abstract Presentations – Ovarian Cancer
AS11. Ovarian cancer
PO010/#673  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. Dae Hoon Jeong6 and
  7. Jung-Yun Lee7
  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. 3Samsung Medical Center, Sungkyunkwan University School of Medicine, Obgyn, 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. 6Department of Obstetrics and Gynecology, Inje University Busan Paik Hospital, Obgyn, Pusan, Korea, Republic of
  7. 7Yonsei 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 PARPi. Here, we report the results from first stage of NIRVANA-R.

Methods This study included patients with platinum-sensitive recurrent ovarian cancer who received at least 2 previous courses of 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. 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 was utilized. Target accrual was 22 patients in the first stage; ≥10 patients with progressive disease within 6 months was required to proceed to second stage.

Results Thirty three of 44 planned patients have been enrolled. Median age was ( ) years old, high grade serous ( ). Median prior lines of therapy ( ); prior bevacizumab ( ). Of the 22 patients from 1st stage, 8 had progressived disease within 6 months. The efficacy boundary to proceed to 2nd stage was met. Data will be updated at the late breaking abstract deadline.

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. Complete interim analysis results will be reported.

https://doi.org/10.1136/ijgc-2023-IGCS.10

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