Multinational phase 3 trial of mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer

Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class antibody-drug conjugate targeting folate receptor α (FRα). The multinational phase 3 MIRASOL trial compared MIRV versus investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicine, or topotecan) for previously treated FRα-positive, platinum-resistant, high-grade serous ovarian cancer. The median investigator-assessed progression-free survival (primary end point) was 5.62 months with MIRV versus 3.98 months with chemotherapy (p<0.001); objective response rate was 42.3% versus 15.9% (OR 3.81; p<0.001); and median overall survival was 16.46 months versus 12.75 months (HR 0.67; p=0.005). During the treatment period, fewer adverse events of grade 3 or higher occurred with MIRV than with chemotherapy (41.7% versus 54.1%), as did serious adverse events of any grade (23.9% versus 32,9%) and events leading to discontinuation (9.2% versus 15.9%). The authors conclude that among participants with platinum-resistant, FRα-positive ovarian cancer, MIRV compared with chemotherapy resulted in significant PFS an OS benefit (quick take video summary).