Olaparib treatment significantly improved objective response rate (primary end point) and progression-free survival versus nonplatinum chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer in the open-label phase III SOLO3 trial (ClinicalTrials.gov identifier: NCT02282020). We report final overall survival (OS; prespecified secondary end point), post hoc OS analysis by number of previous chemotherapy lines, and exploratory BRCA reversion mutation analysis. Two hundred sixty-six patients were randomly assigned 2:1 to olaparib tablets (300 mg twice daily; n = 178) or physician's choice of single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan; n = 88). OS was similar with olaparib versus chemotherapy (hazard ratio [HR], 1.07 [95% CI, 0.76 to 1.49]; P = .71, median 34.9 and 32.9 months, respectively, full analysis set). OS with olaparib was favorable in patients with two previous chemotherapy lines (HR, 0.83 [olaparib v chemotherapy] [95% CI, 0.51 to 1.38]; median 37.9 v 28.8 months); however, a potential detrimental effect was seen in patients with at least three previous chemotherapy lines (HR, 1.33 [95% CI, 0.84 to 2.18]; median 29.9 v 39.4 months). BRCA reversion mutations might have contributed to this finding. No patient randomly assigned to olaparib with a BRCA reversion mutation detected at baseline (6 of 170 [3.5%]) achieved an objective tumor response.

Asan Medical Center Seoul South Korea

Biostatistics Oncology Biometrics Oncology R and D AstraZeneca Cambridge United Kingdom

Centro Medico Dalinde Mexico City Mexico

Department of Medicine and Surgery University of Milan Bicocca Milan Italy

Department of Obstetrics and Gynecology 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

Gynecologic Oncology Program European Institute of Oncology IRCCS Milan Italy

Harvard Medical School Massachusetts General Hospital Boston MA

Instituto COI de Educação e Pesquisa Rio de Janeiro Brazil

Korea Institute of Radiological and Medical Sciences Seoul South Korea

Maria Sklodowska Curie National Research Institute of Oncology Warsaw Poland

O'Neal Comprehensive Cancer Center University of Alabama Birmingham AL

Oaxaca Site Management Organization Oaxaca de Juarez Mexico

Oncology R and D Late stage Development AstraZeneca Cambridge United Kingdom

Oncology R and D Late stage Development AstraZeneca Gaithersburg MD

Poznan University of Medical Sciences Poznań Poland

Seoul National University Hospital Seoul South Korea

Translational Medicine Oncology R and D AstraZeneca Cambridge United Kingdom

Università Cattolica del Sacro Cuore Fondazione Policlinico A Gemelli IRCCS Rome Italy

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ClinicalTrials.gov
NCT02282020