Niraparib Shows Longer Survival in HRD-Positive Ovarian Cancer
A retrospective Italian analysis links first-line niraparib maintenance with markedly longer progression-free and overall survival in HRD-positive patients.
Updated on Nov. 11, 2026 in Cancer
A retrospective analysis of 40 molecularly evaluable patients with optimally debulked ovarian cancer found median progression-free survival of 54 months in HRD-positive patients versus 14 months in HRD-negative patients receiving first-line niraparib maintenance. The findings were presented as a poster at the ESMO Congress 2026.
Why it matters
The study addresses a gap in the phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial, which excluded patients with stage III disease and no residual disease after primary cytoreductive surgery. It adds real-world evidence on how homologous recombination deficiency status may guide niraparib use in ovarian cancer treatment.
The evidence comes from a retrospective cohort of 40 evaluable patients treated at Policlinico Gemelli in Rome between 2020 and 2021, with median PFS of 54 months for HRD-positive patients versus 14 months for HRD-negative patients. Median follow-up was 52 months, and whether these gaps hold in larger prospective populations remains unresolved.
The players
Policlinico Gemelli
A large academic hospital in Rome, Italy, where the retrospective niraparib study was conducted.
ESMO Congress
The annual congress of the European Society for Medical Oncology, a leading forum for oncology research presentations.
The details
Investigators reviewed patients who received niraparib through an expanded access program, with HRD status determined by the Myriad Genetics algorithm and somatic alterations assessed with the TruSight Oncology 500 panel. Progression or death occurred in 45% of HRD-positive patients and 75% of HRD-negative patients, while deaths occurred in 20% and 60% respectively.
Timeline
2020 to 2021: Patients in the analysis received niraparib through the expanded access program.
June 2025: The FDA narrowed the niraparib first-line maintenance indication to HRD-positive patients.
October 23-27, 2026: The ESMO Congress in Madrid, Spain, where the data were presented.
Health Landscape
The study builds on the FDA's June 2025 decision to limit niraparib first-line maintenance to HRD-positive patients, offering observational survival data that compares both biomarker groups. It sits alongside the phase 3 PRIMA trial as an effort to clarify how homologous recombination deficiency status should shape maintenance therapy decisions in ovarian cancer.
For women with newly diagnosed advanced ovarian cancer, HRD testing may influence whether niraparib maintenance is an appropriate first-line option. Patients and clinicians should discuss biomarker results and their treatment implications with their oncology team.
The takeaway
Homologous recombination deficiency status appears to be a meaningful marker of long-term benefit from niraparib, and biomarker testing may help guide maintenance decisions for eligible patients.
Further reading
For more on how biomarker testing is shaping treatment choices, explore our Cancer coverage.
Source note: This article includes information reported by OncLive.
