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).

Jung-Yun Lee; Hyun-Woong Cho; Jeong-Yeol Park; Byoung-Gie Kim; Min Chul Choi; Jae-Weon Kim; Myong Cheol Lim; Dae Hoon Jeong

Objective: 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 2 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 was utilized. Target accrual was 22 patients in the first stage; =13 patients without progressive disease within 6 months was 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 most 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% confidence interval=48.9%-90.2%). The efficacy boundary to proceed to the second stage was met. No grade 4 treatment-related adverse events were reported, and no TRAEs leading to treatment discontinuation. Conclusion: 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 in the future.

OVARIAN cancer; POLY(ADP-ribose) polymerase; BEVACIZUMAB; ADVERSE health care events; PROGRESSION-free survival

Journal of Gynecologic Oncology, 2024, Vol 35, p65

2005-0380

Academic Journal

10.3802/jgo.2024.35.S2.PI-SO2