Phase 1 Trial of Ovarian Cancer Therapy Mirvetuximab Supports Phase 3 Study

Phase 1 Trial of Ovarian Cancer Therapy Mirvetuximab Supports Phase 3 Study
Results from a Phase 1 clinical trial of mirvetuximab soravtansine (IMGN853) as a treatment for  chemotherapy-resistant ovarian cancer and other malignancies have propelled the therapy into a Phase 3 trial. Researchers used the Phase 1 findings to determine a suitable dose for further trials, according to the treatment's developer, ImmunoGen. The study, “Phase 1 Dose-Escalation Study of Mirvetuximab Soravtansine (IMGN853), a Folate Receptor α-Targeting Antibody-Drug Conjugate, in Patients With Solid Tumors,” appeared in the journal Cancer. “These Phase 1 results have played an important role in determining the appropriate dose for mirvetuximab soravtansine in the recently initiated Phase 3 FORWARD I trial of patients with platinum-resistant ovarian cancer,” said Dr. Kathleen Moore, an associate professor at the Stephenson Cancer Center at the University of Oklahoma, who led the study. The trial (NCT01609556) tested increasing doses of the treatment in 44 patients with recurrent ovarian, endometrial, kidney, and lung cancer. Ovarian cancer patients made up 52 percent of the group. Participants received the treatment — given intravenously — on day 1 of a 21-day cycle. Patients were assigned to doses of either 0.15, 0.5, 1.0, 2.0, 3.3, 5.0, or 7.0 mg/kg of mirvetuximab until toxic side effects were noted or the patient's disease progressed. The testing allowed researchers to set an optimal dose for future trials of 6.0 mg of mirvetuximab per kilogram. Most adverse events during the trial were mild. The reactions that showed up the most were fatigue, blurred vision and diarrhea. Although the study was designed to assess the safety and dosing of the treatment, researchers also kept an eye on the treatment’s anti-cancer potential. Two o
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