# PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer

Source: https://onco.cc/key-papers/paper-prima-niraparib-nejm-2019/  
OnCo record `paper-prima-niraparib-nejm-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Niraparib maintenance after first-line chemotherapy delayed progression in newly diagnosed advanced ovarian cancer whether or not the tumour had a homologous recombination deficiency, though the gain was much larger when it did.

## Summary

Phase 3 placebo-controlled trial of 733 patients with newly diagnosed advanced high-grade ovarian cancer at high risk of relapse who had responded to platinum chemotherapy, randomised to niraparib or placebo maintenance.

In homologous recombination-deficient tumours median progression-free survival was 21.9 versus 10.4 months (hazard ratio 0.43); in the overall population it was 13.8 versus 8.2 months (hazard ratio 0.62), with a smaller benefit in homologous recombination-proficient disease (hazard ratio 0.68).

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2019
- DOI: 10.1056/NEJMoa1910962
- Authors: González-Martín A, Pothuri B, Vergote I, et al.
- Findings: Homologous recombination-deficient: median progression-free survival 21.9 vs 10.4 months; hazard ratio 0.43.; Overall population: 13.8 vs 8.2 months; hazard ratio 0.62.
- What it means: Niraparib is approved as first-line maintenance for all comers, making PARP inhibitor maintenance available beyond BRCA-mutated disease, though the benefit in proficient tumours is modest and long-term survival data are neutral.
- Caveats: No overall survival benefit at final analysis.; Haematological toxicity requires individualised starting doses.

## Sources

- N Engl J Med 2019: https://doi.org/10.1056/NEJMoa1910962
- PubMed: https://pubmed.ncbi.nlm.nih.gov/31562799/

## Connected records

- cancers: [High-grade serous ovarian cancer](https://onco.cc/cancers/high-grade-serous-ovarian-cancer/), [Platinum-sensitive ovarian cancer](https://onco.cc/cancers/platinum-sensitive-ovarian-cancer/)
- drugs: [Niraparib](https://onco.cc/drugs/niraparib/)
- trials: [PRIMA / ENGOT-OV26](https://onco.cc/trials/prima/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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