{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T22:58:50Z","timestamp":1792277930649,"version":"4.4.0"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"26","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,9,10]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>\n              Patients with platinum-resistant\/platinum-refractory high-grade serous ovarian cancer (HGSOC) without a\n              <jats:italic toggle=\"yes\">BRCA<\/jats:italic>\n              mutation have poor prognosis and limited treatment options. We report efficacy and biomarker data from EPIK-O, which investigated alpelisib + olaparib versus single-agent chemotherapy in these patients.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>PATIENTS AND METHODS<\/jats:title>\n            <jats:p>\n              EPIK-O was an open-label, phase III trial that randomly assigned patients with platinum-resistant\/platinum-refractory HGSOC with no germline or known somatic\n              <jats:italic toggle=\"yes\">BRCA<\/jats:italic>\n              mutation 1:1 to alpelisib 200 mg once daily + olaparib 200 mg twice daily or treatment of physician's choice (TPC; paclitaxel 80 mg\/m\n              <jats:sup>2<\/jats:sup>\n              once weekly or pegylated liposomal doxorubicin 40-50 mg\/m\n              <jats:sup>2<\/jats:sup>\n              once every 28 days). Patients had 1-3 previous systemic therapies. Previous bevacizumab was required (unless contraindicated); previous poly(adenosine diphosphate-ribose) polymerase inhibitors were allowed. Primary end point was progression-free survival (PFS) per RECIST 1.1 (blinded independent review committee [BIRC]). Secondary efficacy end points included overall response rate (ORR; per BIRC), duration of response (per BIRC), and overall survival (OS; key secondary end point).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              A total of 358 patients (alpelisib + olaparib [n = 180], TPC [n = 178]) were included. The median follow-up time was 9.3 months. At data cutoff (April 21, 2023), 33 (18.3%) and 30 (16.9%) patients remained on treatment with alpelisib + olaparib and TPC, respectively. The median PFS (BIRC) was 3.6 versus 3.9 months (hazard ratio [HR], 1.14 [95% CI, 0.88 to 1.48]; one-sided\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              = .84) for alpelisib + olaparib versus TPC. The ORR was 15.6% (95% CI, 10.6% to 21.7%) versus 13.5% (95% CI, 8.8% to 19.4%). The median OS was 10.0 versus 10.6 months (HR, 1.22; 95% CI, 0.87 to 1.71). The safety profile of alpelisib + olaparib was consistent with that observed for the individual agents.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>The primary objective, PFS improvement, was not met in EPIK-O. No new or unexpected adverse events were observed. Biomarker analyses provided new insights for responders to alpelisib + olaparib.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco-25-00225","type":"journal-article","created":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T19:59:28Z","timestamp":1753300768000},"page":"2908-2917","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":9,"title":["Primary Analysis of EPIK-O\/ENGOT-ov61: Alpelisib Plus Olaparib Versus Chemotherapy in Platinum-Resistant or Platinum-Refractory High-Grade Serous Ovarian Cancer Without\n            <i>BRCA<\/i>\n            Mutation"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct04729387","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1032-1479","authenticated-orcid":true,"given":"Panagiotis A.","family":"Konstantinopoulos","sequence":"first","affiliation":[{"name":"Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1835-9436","authenticated-orcid":true,"given":"Jae Weon","family":"Kim","sequence":"additional","affiliation":[{"name":"Seoul National University, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6001-164X","authenticated-orcid":true,"given":"Gilles","family":"Freyer","sequence":"additional","affiliation":[{"name":"HCL Cancer Institute, Lyon, France"},{"name":"GINECO, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7948-1350","authenticated-orcid":true,"given":"Jung Yun","family":"Lee","sequence":"additional","affiliation":[{"name":"Yonsei Cancer Center and Severance Hospital, Yonsei University, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6898-0557","authenticated-orcid":true,"given":"Lydia","family":"Gaba","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Hospital Clinic, and Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel N.","family":"Grisham","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2225-715X","authenticated-orcid":true,"given":"Nicoletta","family":"Colombo","sequence":"additional","affiliation":[{"name":"European Institute of Oncology IRCSS, Milan, Italy"},{"name":"Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy"},{"name":"MaNGO, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7664-8327","authenticated-orcid":true,"given":"Xiaohua","family":"Wu","sequence":"additional","affiliation":[{"name":"Fudan University Shanghai Cancer Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jalid","family":"Sehouli","sequence":"additional","affiliation":[{"name":"Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"},{"name":"NOGGO, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4558-4850","authenticated-orcid":true,"given":"Felipe","family":"Cruz","sequence":"additional","affiliation":[{"name":"Instituto Brasileiro de Controle do C\u00e2ncer, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6387-9356","authenticated-orcid":true,"given":"David","family":"Cibula","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Obstetrics and Neonatology, General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6985-0159","authenticated-orcid":true,"given":"Bradley J.","family":"Monk","sequence":"additional","affiliation":[{"name":"Florida Cancer Specialists and Research Institute, West Palm Beach, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gitte-Bettina","family":"Nyvang","sequence":"additional","affiliation":[{"name":"Odense University Hospital, Odense, Denmark"},{"name":"NSGO-CTU, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3090-795X","authenticated-orcid":true,"given":"Michael","family":"Friedlander","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Prince of Wales Hospital and Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0981-0598","authenticated-orcid":true,"given":"Domenica","family":"Lorusso","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy"},{"name":"Gynaecological Oncology Medical Unit, Humanitas San Pio X Hospital, Milan, Italy"},{"name":"Department of Women and Child Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Els","family":"Van Nieuwenhuysen","sequence":"additional","affiliation":[{"name":"UZ Leuven, Leuven, Belgium"},{"name":"BGOG, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9354-9550","authenticated-orcid":true,"given":"Rozita","family":"Malik","sequence":"additional","affiliation":[{"name":"University of Malaya, Kuala Lumpur, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosalind","family":"Glasspool","sequence":"additional","affiliation":[{"name":"Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, United Kingdom"},{"name":"GTG-UK\/SGCTG, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8965-9981","authenticated-orcid":true,"given":"Christian","family":"Marth","sequence":"additional","affiliation":[{"name":"Medizinische Universit\u00e4t Innsbruck, Innsbruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2043-2244","authenticated-orcid":true,"given":"Alexandra","family":"Leary","sequence":"additional","affiliation":[{"name":"GINECO, Paris, France"},{"name":"Gustave Roussy, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfonso","family":"Cort\u00e9s-Salgado","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Hospital Universitario Ram\u00f3n y Cajal (IRYCIS), Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Zamagni","sequence":"additional","affiliation":[{"name":"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6591-3367","authenticated-orcid":true,"given":"Frederik","family":"Marm\u00e9","sequence":"additional","affiliation":[{"name":"Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jozef","family":"Sufliarsky","sequence":"additional","affiliation":[{"name":"Comenius University Bratislava, National Cancer Institute, Bratislava, Slovakia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patsy","family":"Hinson","sequence":"additional","affiliation":[{"name":"Ovarian Cancer Research Alliance (OCRA), New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Zuradelli","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1804-2463","authenticated-orcid":true,"given":"Craig","family":"Wang","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4121-0944","authenticated-orcid":true,"given":"Fei","family":"Su","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ines","family":"Paule","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Miller","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3103-6992","authenticated-orcid":true,"given":"Ursula A.","family":"Matulonis","sequence":"additional","affiliation":[{"name":"Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8376-9576","authenticated-orcid":true,"given":"Antonio","family":"Gonz\u00e1lez-Mart\u00edn","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, and Programme in Solid Tumours-CIMA, Cancer Center Cl\u00ednica Universidad de Navarra, Madrid, Spain"},{"name":"GEICO, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_8_2_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.00194"},{"key":"e_1_3_8_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/IGC.0b013e3182049273"},{"key":"e_1_3_8_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mds203"},{"key":"e_1_3_8_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70214-5"},{"key":"e_1_3_8_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30029-4"},{"key":"e_1_3_8_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw133"},{"key":"e_1_3_8_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2017.08.022"},{"key":"e_1_3_8_9_2","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-13-0865"},{"key":"e_1_3_8_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813904"},{"key":"e_1_3_8_11_2","doi-asserted-by":"publisher","DOI":"10.2217\/fon-2022-0666"},{"key":"e_1_3_8_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw672"},{"key":"e_1_3_8_13_2","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-11-0348"},{"key":"e_1_3_8_14_2","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-11-0336"},{"key":"e_1_3_8_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30905-7"},{"key":"e_1_3_8_16_2","unstructured":"Novartis Pharmaceuticals Corporation: PIQRAY\u00ae (alpelisib) [prescribing information]. 2024"},{"key":"e_1_3_8_17_2","unstructured":"AstraZeneca Pharmaceuticals: LYNPARZA (olaparib) [prescribing information]. 2023"},{"key":"e_1_3_8_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00216-3"},{"key":"e_1_3_8_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2023.10.005"},{"key":"e_1_3_8_20_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.02915"},{"key":"e_1_3_8_21_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.63.1408"},{"key":"e_1_3_8_22_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1911361"},{"key":"e_1_3_8_23_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.01009"},{"key":"e_1_3_8_24_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910962"},{"key":"e_1_3_8_25_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.23.02005"},{"key":"e_1_3_8_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2024.07.017"},{"key":"e_1_3_8_27_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.01900"},{"key":"e_1_3_8_28_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2309169"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO-25-00225","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T22:01:14Z","timestamp":1757109674000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO-25-00225"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,10]]},"references-count":27,"journal-issue":{"issue":"26","published-print":{"date-parts":[[2025,9,10]]}},"alternative-id":["10.1200\/JCO-25-00225"],"URL":"https:\/\/doi.org\/10.1200\/jco-25-00225","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,10]]},"assertion":[{"value":"2025-01-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-27","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-06","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}