{"entity":{"id":"solo-1","kind":"trial","name":"SOLO-1","aka":[],"tldr":"Two years of an olaparib pill after chemotherapy made a large share of women with BRCA-mutated ovarian cancer long-term survivors.","summary":"PFS HR 0.30 at the primary analysis (NEJM 2018). At 7 years, 67.0% of olaparib patients were alive versus 46.5% on placebo (HR 0.55; JCO 2023), the first PARP inhibitor trial with a clinically meaningful overall survival gain in the first-line setting and the basis for the 2018 maintenance approval. Roughly half of olaparib patients remained progression-free at 5 years.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01844986","url":"https://clinicaltrials.gov/study/NCT01844986"},{"label":"NEJM 2018","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1810858"},{"label":"7-year OS, JCO 2023","url":"https://ascopubs.org/doi/10.1200/JCO.22.01549"}],"tags":[],"related":[],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kathleen-moore"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01844986","phase":"3","setting":"Newly diagnosed advanced BRCA-mutated ovarian cancer in response to platinum chemotherapy: olaparib maintenance for 2 years vs placebo","sponsor":"AstraZeneca / Merck","result":"PFS HR 0.30; 7-year OS 67.0% vs 46.5% (HR 0.55).","started":"2013-08-26","startedType":"actual","yearReported":2018,"enrolled":391,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 450 participants (actual); the NEJM 2018 primary analysis randomised 391 patients (260 olaparib, 131 placebo).","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"HR","arms":[{"name":"Olaparib","n":260},{"name":"Placebo","n":131}],"hr":0.3,"ci":[0.23,0.41],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1810858"},{"endpoint":"Overall survival at 7 years","unit":"%","arms":[{"name":"Olaparib","value":67},{"name":"Placebo","value":46.5}],"hr":0.55,"ci":[0.4,0.76],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01549"}],"replication":"PRIMA (niraparib) and PAOLA-1 (olaparib + bevacizumab) reproduced the PFS effect in HRD-positive disease; only SOLO-1 has shown a clear OS gain."},"route":"/trials/solo-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":"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/"}],"drug":[{"id":"bracanalysis-cdx","kind":"drug","name":"BRACAnalysis CDx","route":"/drugs/bracanalysis-cdx/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"person":[{"id":"kathleen-moore","kind":"person","name":"Kathleen N. Moore","route":"/people/kathleen-moore/"}],"idea":[{"id":"idea-ctdna-guided-parp-duration","kind":"idea","name":"ctDNA-guided duration of PARP maintenance","route":"/ideas/idea-ctdna-guided-parp-duration/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}