ImmunoGen, Inc. chalked up a clear victory in the confirmatory Phase III MIRASOL trial of Elahere (mirvetuximab soravtansine-gynx) among pretreated patients with folate receptor alpha (FRα)-positive platinum chemotherapy-resistant ovarian cancer, as the drug became the first to demonstrate an overall survival (OS) advantage in that population. The company sees the data as enabling it to extend the drug’s reach into Europe while also building confidence in its ability to expand into other ovarian cancer subpopulations.
The company announced data from the 453-patient MIRASOL trial on 3 May, highlighting that the results showed statistically significant improvements among patients receiving the antibody-drug conjugate (ADC) in OS as well as progression-free survival (PFS) and overall response rate (ORR) compared with those receiving chemotherapy. Elahere won accelerated approval from the US Food and Drug Administration in 2022 for FRα-positive, platinum-resistant epithelial ovarian, fallopian tube and primary peritoneal cancer in patients with one to three prior lines of therapy, based on ORR data in the Phase III SORAYA trial
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