Introduction/Background Niraparib is a PARP inhibitor approved in Europe as maintenance monotherapy in advanced ovarian cancer (aOC) after response to 1L platinum-based chemotherapy. PRIMA/ENGOT-ov26/GOG-3012 showed significant improvement in progression-free survival in aOC with niraparib versus placebo. An early access program (cohort [c]ATU) in France allowed real-world patients with newly-diagnosed aOC who had limited treatment options to receive 1L maintenance treatment with niraparib, when bevacizumab maintenance was not an option for BRCA wild-type patients.

Methodology Patients with newly-diagnosed aOC, including patients without residual disease (RD), were eligible if they had response following platinum-based chemotherapy, were not eligible for bevacizumab, and lacked a BRCA mutation. Niraparib was administered orally (200/300 mg/day) by baseline weight and platelet count.

Results From August 2020-March 2021, 67 oncologists from 55 hospitals completed evaluations for 82 patients with newly-diagnosed aOC; 73 met all eligibility criteria; 67 were exposed to niraparib. Baseline characteristics (table 1) showed that of 48 patients with prior surgery, 36 had interval debulking and 12 upfront surgery; 94% (34/36) and 100% (12/12) had no RD, respectively. Mean niraparib dose at treatment initiation was 207.8 mg/day compared with 181.3 mg/day reported in PRIMA (Mirza, et al. J Clin Oncol;2020:38(15 suppl):6050). Niraparib was discontinued before the end of the ATU period in 8/67 patients (due to adverse events [AEs], n=4; disease progression, n=3; patient request, n=1). 86 treatment-related AEs occurred in 28/67 patients, most commonly thrombocytopenia (25% of patients [grade 3/4 in 7%]), nausea (10% [1%]), and abnormal haemoglobin (9% [0%]).

Conclusion In the first real-life data from patients without maintenance treatment options, no additional safety concerns were observed with niraparib at a comparable median dose versus PRIMA in an older population. The enrolment of 67 patients in 8 months highlights the need for access to treatments for patients with newly-diagnosed aOC in France.