Dr. Moore on Results of the FORWARD I/GOG 3011 Trial in Ovarian Cancer

Kathleen Moore, MD, director, Oklahoma TSET Phase I Clinical Trials Program, and associate professor, Section of Gynecologic Oncology, Jim and Christy Everest Endowed Chair in Cancer Research, director, Gynecologic Oncology Fellowship Program, associate director of Clinical Research, and medical director of the Clinical Trials Office, at Stephenson Cancer Center, discusses topline findings from the phase III FORWARD I/GOG 3011 trial in ovarian cancer.

Updated data from the phase III FORWARD 1/GOG 3011 trial showed no new safety signals with mirvetuximab soravtansine in patients with folate receptor (FR) α—high ovarian cancer. Fewer patients experienced grade 3 treatment-emergent adverse events (AEs) with mirvetuximab versus the investigator’s choice of chemotherapy. Additionally, fewer patients had to dose reduce because of treatment-emergent AEs with mirvetuximab, says Moore. Patients in the mirvetuximab arm experienced expected rates of nausea, diarrhea, and visual disturbances; all events were low-grade and mitigated with preplanned interventions.

In terms of efficacy, the study did not show a statistically significant improvement in progression-free survival (PFS) with mirvetuximab, adds Moore. The median PFS was 3.3 months in the control arm and 4.8 months in the FRα-high population; this translated to a hazard ratio of 0.693 and a P value that was less than 0.05, which failed to meet the study’s prespecified P value of less than 0.025.