{"entity":{"id":"paper-prima-niraparib-nejm-2019","kind":"paper","name":"PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer","aka":[],"tldr":"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.\n\nIn 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).","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2019","url":"https://doi.org/10.1056/NEJMoa1910962"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/31562799/"}],"tags":[],"related":[],"cancers":["platinum-sensitive-ovarian-cancer","high-grade-serous-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["niraparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["prima"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2019,"doi":"10.1056/NEJMoa1910962","pmid":"31562799","authors":"González-Martín A, Pothuri B, Vergote I, et al.","paperType":"rct","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."],"whatItMeans":"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."],"changedPractice":true,"participants":733},"route":"/key-papers/paper-prima-niraparib-nejm-2019/","neighbours":{"cancer":[{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"}],"drug":[{"id":"niraparib","kind":"drug","name":"Niraparib","route":"/drugs/niraparib/"}],"trial":[{"id":"prima","kind":"trial","name":"PRIMA / ENGOT-OV26","route":"/trials/prima/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}