ImmunoGen Reports P-III Trial (MIRASOL) Results of Elahere (mirvetuximab soravtansine) for FRα-Positive Platinum-Resistant Ovarian Cancer
Shots:
- The P-III trial (MIRASOL) evaluating Elahere vs CT in 453 patients who have received 1 to 3 prior lines of therapy. At the data cutoff on Mar 2023, the median follow-up time for OS was 13.1mos.; 14% vs 3% remained on the study drug
- Improvement in OS with m-OS (16.46 vs 12.75mos.), a 33% reduction in risk of death, improved PFS with a 35% reduction in risk of tumor progression or death, m-PFS (5.62 vs 3.98mos.), ORR (42.3% incl. 12 CRs vs 15.9% with no CRs)
- Low-grade ocular & gastrointestinal events continue to dominate the safety profile of Elahere. No new safety signals were seen, lower rates of grade ≥3 TEAEs (42% vs 54%); SAEs (24% vs 33%); study drug discontinuation due to TEAEs (9% vs 16%). The company intends to submit an MAA in the EU & an sBLA to the US FDA in H2’23
Ref: ImmunoGen | Image: ImmunoGen
Related News:- ImmunoGen’s Elahere Receive the US FDA’s Approval for the Treatment of Platinum-Resistant Ovarian Cancer
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