{"entity":{"id":"prima","kind":"trial","name":"PRIMA / ENGOT-OV26","aka":[],"tldr":"Extended PARP maintenance to women without BRCA mutations, but the survival benefit did not materialise on longer follow-up.","summary":"PFS 13.8 vs 8.2 months overall (HR 0.62) and 21.9 vs 10.4 months in HRD-positive disease (HR 0.43; NEJM 2019), leading to an all-comers first-line maintenance approval in 2020. The final overall survival analysis (2024) showed no OS difference (HR 1.01 overall), and the HR-proficient subgroup's benefit was small, prompting label debates and a shift toward HRD-guided use.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02655016","url":"https://clinicaltrials.gov/study/NCT02655016"},{"label":"NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910962"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp"],"drugs":["niraparib"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["hrd"],"trials":[],"people":["antonio-gonzalez-martin"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02655016","phase":"3","setting":"Newly diagnosed advanced ovarian cancer at high risk of relapse, any BRCA/HRD status: niraparib maintenance vs placebo","sponsor":"GSK (Tesaro)","result":"PFS HR 0.62 overall, 0.43 HRD-positive; final OS HR 1.01.","started":"2016-07-11","startedType":"actual","yearReported":2019,"enrolled":733,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (HRD-positive)","primary":true,"unit":"months","arms":[{"name":"Niraparib","value":21.9},{"name":"Placebo","value":10.4}],"hr":0.43,"ci":[0.31,0.59],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910962"},{"endpoint":"Progression-free survival (overall)","primary":true,"unit":"months","arms":[{"name":"Niraparib","n":487,"value":13.8},{"name":"Placebo","n":246,"value":8.2}],"hr":0.62,"ci":[0.5,0.76],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1910962"}],"replication":"ATHENA-MONO (rucaparib) reproduced the all-comers PFS gain; no all-comers OS benefit has been shown for any PARP inhibitor."},"route":"/trials/prima/","neighbours":{"cancer":[{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"}],"technology":[{"id":"hrd-genomic-scar-scores","kind":"technology","name":"HRD genomic scar scores (GIS, LOH, HRDetect)","route":"/technologies/hrd-genomic-scar-scores/"},{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"target":[{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"drug":[{"id":"mychoice-cdx","kind":"drug","name":"myChoice CDx","route":"/drugs/mychoice-cdx/"},{"id":"niraparib","kind":"drug","name":"Niraparib","route":"/drugs/niraparib/"}],"company":[{"id":"lysa","kind":"company","name":"LYSA (The Lymphoma Study Association)","route":"/companies/lysa/"}],"term":[{"id":"hrd","kind":"term","name":"Homologous recombination deficiency (HRD)","route":"/terms/hrd/"}],"person":[{"id":"antonio-gonzalez-martin","kind":"person","name":"Antonio González-Martín","route":"/people/antonio-gonzalez-martin/"}],"idea":[{"id":"idea-ctdna-guided-parp-duration","kind":"idea","name":"ctDNA-guided duration of PARP maintenance","route":"/ideas/idea-ctdna-guided-parp-duration/"}],"paper":[{"id":"paper-prima-niraparib-nejm-2019","kind":"paper","name":"PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer","route":"/key-papers/paper-prima-niraparib-nejm-2019/"}]}}