ImmunoGen reports ‘positive’ results from Phase 3 MIRASOL trial

ImmunoGen announced positive top-line data from the Phase 3 confirmatory MIRASOL trial evaluating the safety and efficacy of ELAHERE compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. Based on these data, the ompany plans to submit a Marketing Authorization Application in Europe and a supplemental Biologics License Application in the U.S. for the conversion to a regular approval of ELAHERE. Results show statistically significant improvements in PFS, ORR, and OS compared to chemotherapy.