Weekly Digest - 29 Apr-05 May 2023

Weekly Digest - 29 Apr-05 May 2023

May 03, 2023: Elahere / FRα-Positive Platinum-Resistant Ovarian Cancer / Immunogen: Phase 3 MIRASOL trial demonstrated improved clinical benefits 

  • Immunogen announced positive top-line data from the Phase 3 confirmatory MIRASOL evaluating Elahere in comparison to Chemo for the treatment of FRα-positive platinum-resistant ovarian cancer with prior one to three prior lines of therapy

  • Statistically significant improvements in PFS, ORR, and OS compared to chemotherapy were observed

    • Median OS: 16.46 months vs 12.75 mont

    • Median PFS: 5.62 months vs 3.98 months

    • ORR: 42.3% vs 15.9%

  • No new safety signals were identified

    • Grade 3 or greater TEAEs: 42% vs 54%
  • Elahere is the first medicine to demonstrate an overall survival advantage in platinum-resistant ovarian cancer
  • Submission of MAA in Europe and sBLA in the US anticipated in H2 2023

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