{"entity":{"id":"paola-1","kind":"trial","name":"PAOLA-1 / ENGOT-ov25","aka":[],"tldr":"Adding olaparib to bevacizumab maintenance roughly doubled progression-free time in tumours with faulty DNA repair, and improved survival in that group.","summary":"PFS 22.1 vs 16.6 months overall (HR 0.59) and 37.2 vs 17.7 months in HRD-positive tumours (HR 0.33; NEJM 2019). Five-year OS in HRD-positive patients was 65.5% vs 48.4% (HR 0.62; Annals of Oncology 2023). No benefit in HRD-negative disease. Approved in 2020 for HRD-positive tumours; it established HRD testing as a decision point.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02477644","url":"https://clinicaltrials.gov/study/NCT02477644"},{"label":"NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911361"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["parp","brca","vegf"],"drugs":["olaparib","bevacizumab"],"companies":["arcagy-gineco"],"institutions":[],"pathways":[],"terms":["hrd"],"trials":[],"people":["isabelle-ray-coquard"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02477644","phase":"3","setting":"Newly diagnosed advanced ovarian cancer already on bevacizumab maintenance: adding olaparib vs placebo","sponsor":"ARCAGY-GINECO / AstraZeneca","result":"PFS HR 0.59 overall, 0.33 HRD-positive; 5-year OS 65.5% vs 48.4% in HRD-positive.","started":"2015-05-06","startedType":"actual","yearReported":2019,"enrolled":806,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (HRD-positive)","unit":"months","arms":[{"name":"Olaparib + bevacizumab","value":37.2},{"name":"Placebo + bevacizumab","value":17.7}],"hr":0.33,"ci":[0.25,0.45],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1911361"},{"endpoint":"Overall survival at 5 years (HRD-positive)","unit":"%","arms":[{"name":"Olaparib + bevacizumab","value":65.5},{"name":"Placebo + bevacizumab","value":48.4}],"hr":0.62,"ci":[0.45,0.85],"source":"https://www.annalsofoncology.org/article/S0923-7534(23)00658-0/fulltext"}]},"route":"/trials/paola-1/","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":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"},{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"mychoice-cdx","kind":"drug","name":"myChoice CDx","route":"/drugs/mychoice-cdx/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"company":[{"id":"arcagy-gineco","kind":"company","name":"ARCAGY-GINECO","route":"/companies/arcagy-gineco/"}],"term":[{"id":"hrd","kind":"term","name":"Homologous recombination deficiency (HRD)","route":"/terms/hrd/"}],"person":[{"id":"isabelle-ray-coquard","kind":"person","name":"Isabelle Ray-Coquard","route":"/people/isabelle-ray-coquard/"}],"pairing":[{"id":"parp-plus-bevacizumab","kind":"pairing","name":"PARP inhibitor + bevacizumab maintenance (HRD-positive)","route":"/pairings/parp-plus-bevacizumab/"}],"institution":[{"id":"sgo","kind":"institution","name":"Society of Gynecologic Oncology","route":"/institutions/sgo/"}]}}