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Kathleen Moore, MD, discusses the anticipated impact of the phase 3 MIRASOL trial with mirvetuximab soravtansine in patients with platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with a high folate receptor alpha expression.
Kathleen Moore, MD, director of the Oklahoma TSET Phase I Clinical Trials Program; associate director of Clinical Research; medical director of the Clinical Trials Office; associate professor in the Section of Gynecologic Oncology; Jim and Christy Everest Endowed Chair in Cancer Research; and director of the Gynecologic Oncology Fellowship Program at Stephenson Cancer Center, discusses the anticipated impact of the phase 3 MIRASOL trial with mirvetuximab soravtansine (IMGN853) in patients with platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with a high folate receptor alpha (FRα) expression.
The MIRASOL study is similar to the phase 3 FORWARD 1 study, says Moore. For the trial, only patients with FRα-high expression will be permitted to enroll; this accounts for less than half of all patients with high-grade serous ovarian cancer.
Eligible patients are permitted to have received 1-3 prior lines of chemotherapy, including bevacizumab (Avastin) and PARP inhibitors. Patients will be randomized 1:1 to receive either mirvetuximab soravtansine or investigator’s choice of chemotherapy. This differs from the FORWARD-1 trial, where patients were randomized 2:1, notes Moore.
The primary end point of the trial is investigator-assessed progression-free survival (PFS), and key secondary end points include response rate, overall survival (OS), and patient-reported outcomes.
This study is currently open and accruing, with some patients currently receiving treatment, says Moore. Sites are being activated in the United States and there will be global sites soon coming soon, although the COVID-19 pandemic has delayed these efforts to a certain extent, according to Moore. Patients are currently screening and enrolling on this trial.
Investigators anticipate that this will be a positive study and that the agent will be approved and made available to patients with recurrent ovarian cancer, Moore explains. This agent can act as another option for those whose disease is platinum-resistant, who have tumors that have progressed through an AURELIA-type regimen with bevacizumab and chemotherapy, or who are ineligible for bevacizumab.
The antibody-drug conjugate provides patients with another treatment option in this landscape of platinum-resistant ovarian cancer, where many options are needed to continuously improve PFS and prolong OS. The agent will be positioned as a monotherapy in this setting, concludes Moore.