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Angeles A. Secord, MD, discusses the design of the phase 3b OReO trial in ovarian cancer.
Angeles A. Secord, MD, gynecologic oncologist, Duke Cancer Center, discusses the design of the phase 3b OReO trial (NCT03106987) in ovarian cancer.
Data from the Oreo trial were presented during the 2021 ESMO Congress. The study included patients with relapsed non-mucinous epithelial ovarian cancer who were previously treated with a PARP inhibitor as maintenance therapy, Secord explains. Patients were split into 2 cohorts: 1 characterized by BCRA mutations and 1 characterized by a lack of BRCA mutations, Secord says. Patients were randomized to receive olaparib (Lynparza) as rechallenged maintenance therapy vs placebo. Dose reductions to 250 mg of twice daily olaparib were permitted if the previous 300 mg dose was not tolerated, Secord explains.
The primary end point of the study was investigator-assessed progression-free survival (PFS). Prior to study entry, approximately 23% of patients overallhad a complete response to platinum-based chemotherapy and approximately 76% had a partial response, Secord continues. Overall, patients have received a range of PARP inhibitors; patients who harbored a non-BRCA mutation were more likely to have received niraparib (Zejula) vs other PARP inhibitors, Secord concludes.