Article Text
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.