RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventshttps://investor.immunogen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm
MIRASOL, the confirmatory Phase 3 randomized trial designed to convert the accelerated approval of ELAHERE to full approval, and top-line data was released in May 2023.
MIRASOL demonstrated an ORR of 32% and mDOR 6.9 months seen in the singlearm Phase 2 SORAYA study to support accelerated approval by the FDA.
During the Biologics License Application review, FDA requested ImmunoGen submit preliminary ORR and DOR data from both arms of MIRASOL. To maintain data integrity for the ongoing MIRASOL trial, an independent third-party statistician performed the analyses and submitted the outputs directly to FDA.
The study met its primary and key secondary endpoints with statistically significant results in PFS (INV), ORR (INV), and OS
https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.17_suppl.LBA5507