- ImmunoGen Inc IMGN announced detailed results from the Phase 3 MIRASOL trial of Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer.
- The results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
- The company reported topline data from the study in May.
- The MIRASOL study enrolled 453 patients.
- Elahere demonstrated a statistically significant and clinically meaningful improvement in Progression Free Survival (PFS) by investigator assessment compared to investigator's choice (IC) chemotherapy, representing a 35% reduction in the risk of tumor progression or death in the Elahere arm compared to the IC chemotherapy arm.
- The median PFS in the Elahere arm was 5.62 months compared to 3.98 months in the IC chemotherapy arm.
- ORR in the Elahere arm was 42.3%, including 12 complete responses (CRs), compared to 15.9%, with no CRs, in the IC chemotherapy arm.
- Clinically meaningful improvements in PFS and overall survival were observed with Elahere regardless of prior Bevacizumab status.
- Elahere was well-tolerated, consistent with the known safety profile seen in the broader development program. No new safety signals were identified in MIRASOL.
- Elahere was associated with lower rates of grade 3 or greater treatment-emergent adverse events (42% vs. 54%) and serious adverse events (24% vs. 33%) compared to IC chemotherapy.
- Price Action: IMGN shares are up 7.86% at $15.50 during the premarket session on the last check Monday.
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