Niraparib Delivers Lasting Benefit in Chinese Ovarian Cancer Patients, Real World Study Shows

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Ovarian cancer remains one of the most lethal gynaecological malignancies worldwide, with a high risk of recurrence even after successful initial treatment. Over the past decade, poly(ADP-ribose) polymerase (PARP) inhibitors have transformed first-line maintenance therapy by significantly prolonging disease control. While randomised clinical trials have established the efficacy of these agents, prospective real-world evidence has remained limited, particularly in Asian populations.

To address this gap, investigators conducted the RENI 1 study, the first prospective, multicentre real-world study of niraparib maintenance therapy in newly diagnosed ovarian cancer in China. The study enrolled 227 patients across 22 hospitals nationwide, creating one of the largest prospective real-world datasets of niraparib maintenance therapy reported in China to date. The study was published in the Chinese Medical Journal on 24th June, 2026.

After a median follow-up of 41.5 months, RENI 1 demonstrated durable and clinically meaningful outcomes. Median progression-free survival (PFS) reached 36.5 months in the intention-to-treat population. Among patients with FIGO stage III to IV disease, median PFS was 25.4 months, consistent with outcomes reported in pivotal clinical trials.

Median PFS was not reached in patients harbouring BRCA1 or BRCA2 mutations or Homologous Recombination Deficiency (HRD), indicating sustained long-term benefit in these biomarker-defined populations. More than half of patients with BRCA1 or BRCA2 mutations remained on niraparib treatment for at least three years, highlighting the feasibility of long-term maintenance therapy in routine clinical practice.

Real-world treatment patterns supported the practicality of niraparib use. Most patients initiated maintenance therapy within 12 weeks of completing chemotherapy and received niraparib monotherapy. Clinical outcomes were generally consistent across subgroups defined by prior bevacizumab exposure, dose modifications, and comorbidity status, suggesting that niraparib can be effectively used in a broad range of patients encountered in everyday practice.

Exploratory analyses identified several factors associated with prolonged PFS, including postoperative R0 resection, primary debulking surgery, complete response to chemotherapy, BRCA1 or BRCA2 mutation, and HRD positivity. These findings may help clinicians better identify patients who are most likely to derive long-term benefit from niraparib maintenance therapy.

The safety profile observed in RENI 1 was consistent with previous clinical studies. Most treatment-related adverse events occurred during the first three months of treatment and were manageable with routine clinical interventions. No new safety signals were identified, and patient-reported outcomes remained stable throughout treatment, indicating that prolonged niraparib maintenance did not adversely affect overall quality of life.

As the first prospective real-world study of niraparib maintenance therapy in China, RENI 1 provides evidence bridging the gap between randomised clinical trials and routine clinical practice. The findings indicate that long-term efficacy, safety, and quality-of-life outcomes can be achieved in a broad and unselected patient population.

Clinicians can draw on these data when discussing maintenance options after chemotherapy, particularly for patients with BRCA mutations or HRD-positive tumours, where benefits appear especially durable. Further follow-up will continue to inform how best to integrate such therapies into standard pathways for ovarian cancer management.

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