At first recurrence, platinum-sensitive ovarian cancer (PSOC) is frequently treated with platinum-based chemotherapy doublets plus bevacizumab, then single-agent bevacizumab. Most patients' disease progresses within a year after chemotherapy, emphasizing the need for novel strategies. Mirvetuximab soravtansine-gynx (MIRV), an antibody-drug conjugate, comprises a folate receptor alpha (FRα)-binding antibody and tubulin-targeting payload (maytansinoid DM4). In FRα-high PSOC, MIRV plus bevacizumab previously showed promising efficacy (objective response rate, 69% [95% CI: 41-89]; median progression-free survival, 13.3 months [95% CI: 8.3-18.3]; median duration of response, 12.9 months [95% CI: 6.5-15.7]) and safety. The Phase III randomized GLORIOSA trial will evaluate MIRV plus bevacizumab vs. bevacizumab alone as maintenance therapy in patients with FRα-high PSOC who did not have disease progression following second-line platinum-based doublet chemotherapy plus bevacizumab.Clinical Trial Registration: ClinicalTrials.gov ID: NCT05445778; GOG.org ID: GOG-3078; ENGOT.ESGO.org ID: ENGOT-ov76.

Most patients with ovarian cancer are initially treated with platinum-based chemotherapy. If the cancer reappears/recurs after more than 6 months following this therapy, it is called platinum-sensitive ovarian cancer (PSOC). Patients with PSOC usually receive additional platinum-based chemotherapy along with bevacizumab, a drug that reduces tumor growth by decreasing its blood supply. If patients improve or are stable on this therapy, they are usually kept on bevacizumab alone for ‘maintenance therapy’. Unfortunately, this maintenance therapy does not work long-term in all patients, so better long-term treatments are needed. The GLORIOSA (NCT05445778) clinical trial will compare maintenance therapy with bevacizumab alone to maintenance therapy with bevacizumab plus a drug called mirvetuximab soravtansine-gynx (MIRV) to determine which therapy leads to better results in patients with PSOC. MIRV is made up of an antibody that binds to a specific protein (folate receptor alpha [FRα]) on cancer cells to directly deliver a cancer-killing drug. MIRV received US FDA approval to be used as a therapy for patients with ovarian cancer who are resistant to platinum-based chemotherapy and express high levels of FRα. The GLORIOSA trial will study maintenance therapy with MIRV plus bevacizumab in patients with PSOC who have not had cancer progression after second-line platinum-based chemotherapy plus bevacizumab, and whose cancer expresses high amounts of FRα. The main purpose of this trial is to determine if MIRV plus bevacizumab leads to better patient survival and decreases cancer growth and spread when compared with bevacizumab alone.

Center of Hope University of Nevada Reno School of Medicine Reno NV 89557 USA

Department of Gynaecology Obstetrics and Neonatology General University Hospital Prague and 1st Faculty of Medicine Charles University Prague 120 00;110 00 Czech Republic

Division of Gynaecological Oncology University Hospital Leuven Leuven Cancer Institute Leuven BGOG 3000 Belgium

Gynaecological Oncology Unit Catholic University of Rome and Fondazione Policlinico Gemelli IRCCS Rome 00168 Italy

Gynaecology Unit The Royal Marsden NHS Foundation Trust and Institute of Cancer Research London SW3 6JJ UK

Gynecologic Oncology Holy Name Medical Center Teaneck NJ 07666 USA

Gynecologic Oncology James Cancer Center The Ohio State University Columbus OH 43210 USA

Gynecologic Oncology Perlmutter Cancer Center NYU Langone Health New York NY 10016 USA

Gynecology and Obstetrics and Gynecological Oncology Carl Gustav Carus University Technische Universität Dresden Dresden 01307 Germany

Medical Affairs ImmunoGen Inc Waltham MA 02451 USA

Medical Oncology Institut Curie PSL Research University INSERM U830 Paris 75006 France

Obstetrics and Gynecology UMass Chan Medical School Springfield MA 01199 USA

Oncology University College London Hospitals NHS Foundation Trust London NW1 2BU UK

Servicio de Oncología Médica Hospital Universitario La Paz IdiPAZ Madrid 28046 Spain

Women's Cancer Care Associates Albany Medical College Albany NY 12208 USA

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