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Monday, June 5, 2023

ImmunoGen is Shooting Higher

 

  • ImmunoGen Inc  announced detailed results from the Phase 3 MIRASOL trial of Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRĪ±)-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.

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