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ImmunoGen to Submit Phase III Trial Results of Elahere to Regulators in US, Europe

NEW YORK – ImmunoGen on Wednesday reported positive data from a Phase III confirmatory trial of Elahere (mirvetuximab soravtansine-gynx) versus chemotherapy in previously treated folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer.

The firm said these results from the Phase III MIRASOL trial will be used to support a marketing authorization application submission for initial approval in Europe and a supplemental biologics license application in the US to convert Elahere from accelerated approval to full approval.

The MIRASOL trial enrolled 453 platinum-resistant ovarian cancer patients whose tumors express high levels of FRα and who had one to three prior lines of treatment to compare Elahere to investigator's choice of chemotherapy. Patients with FRα expression were identified using Roche's Ventana FOLR1 Assay, the approved companion diagnostic to Elahere.

Elahere demonstrated improved survival and response compared to chemotherapy. Median progression-free survival was 5.62 months in the Elahere arm compared to 3.98 months in the chemo arm, and median overall survival was 16.46 months on Elahere compared to 12.75 months on chemo. Elahere also led to more responses with 42.3 percent of patients responding to the treatment, including 12 complete responses compared to 15.9 percent of patients responding to chemo.

"We believe these data will provide the foundation for pursuing a marketing authorization in Europe and elsewhere, and seeking full approval in the US, support our goal of delivering Elahere to FRα-positive patients worldwide, and reinforce our conviction in our clinical development program to move this therapy into broader populations, including platinum-sensitive disease," ImmunoGen CEO Mark Enyedy said in a statement.

Elahere was granted accelerated approval in the US last year for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received up to three prior systemic treatments. ImmunoGen is also studying the drug in earlier lines of therapy and in combination trials.