ImmunoGen Inc (NASDAQ: IMGN) shares are shooting higher on Wednesday after it announced top-line data from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy for folate receptor alpha (FRĪ±)-positive platinum-resistant ovarian cancer patients who have received therapy.
Elahere demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the investigator's choice (IC) chemotherapy.
With 204 OS events reported as of March 6, 2023, the median OS was 16.46 months in the Elahere arm, compared to 12.75 months in the IC chemotherapy arm, representing a 33% reduction in the risk of death in the Elahere arm.
Elahere demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), representing a 35% reduction in tumor progression or death risk.
The median PFS in the ELAHERE arm was 5.62 months, compared to 3.98 months in the IC chemotherapy arm.
The objective response rate was 42.3%, including 12 complete responses (CRs), compared to 15.9%, with no CRs, in the IC chemotherapy arm.
ImmunoGen plans to submit an MAA to the European Medicines Agency and an sBLA to the FDA in the second half of this year.
https://finance.yahoo.com/news/immunogen-touts-additional-positive-data-154516127.html
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