STUDY DESIGN

Niraparib is a potent and highly selective poly-ADP ribose polymerase (PARP) inhibitor.¹ PARP inhibitors have shown a trend of favorable overall survival (OS) in platinum-sensitive recurrent ovarian cancer (PSROC) in the maintenance setting.¹ However, this OS benefit appears inconsistent in patients without BReast CAncer gene (BRCA) mutations which has been attributed to confounding factors, such as post-progression therapies.¹

The Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA) trial is a randomized, double-blinded, placebo-controlled phase 3 study conducted in the Chinese population.¹ The trial assessed niraparib as a maintenance therapy in PSROC using an individualized starting dose (ISD).¹ Participants had high-grade serous, high-grade predominantly serous histology or germline BRCA mutations (gBRCAm) and had completed ≥2 previous lines of platinum-containing therapy with a partial or complete response.¹ They were randomized 2:1 to receive niraparib or a matching placebo and were dosed according to an ISD.¹ Patients received a 300mg QD dose unless they had a body weight of <77kg and/or a platelet count of <150,000/μL, in which case 200mg QD was used instead.¹

The primary endpoint of the study was progression-free survival (PFS) by blinded independent central review (BICR).¹ Secondary outcomes included OS results as well as the chemotherapy-free interval (CFI), the time to first subsequent treatment (TFST), as well as safety outcomes.¹ At the primary analysis, niraparib has shown significant improvement over placebo in terms of PFS regardless of gBRCAm status.¹ Another interim analysis revealed OS benefits across gBRCAm status with the use of ISD.¹ In the captioned analysis, the results of the final OS analysis from NORA have been presented.¹ Additionally, the safety analysis in terms of incidences of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and other second primary malignancies were also summarized.¹

“The phase 3 NORA trial continues to support the use of niraparib maintenance therapy with ISD for patients with PSROC, regardless of gBRCAm status.”