SpringWorks Therapeutics Reports the Results for Mirdametinib in P-IIb Trial to Treat Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN)
- The P-IIb (ReNeu) study evaluates the safety, efficacy & tolerability of mirdametinib (2mg/m2, BID) in 2 cohorts (pediatric & adult) on patients (n=114) with NF1-PN across 50 sites in the US. The 1EP of the study includes ORR & 2EPs include safety, tolerability, DoR & changes from baseline
- As per the data cutoff date (Sep 20, 2023), ORR of 52% & 41% were seen in patients within the 24-cycle treatment and 1 & 2 patients achieved confirmed OR post Cycle 24. The change from baseline in target tumor volume was -42% & -41% whereas mDoR was not reached in either cohort
- Mirdametinib has received the US FDA’s ODD for NF1, FTD for NF1-PN & RPD Designation for NF1. An NDA submission to the US FDA is expected by H1’24
Ref: SpringWorks | Image: SpringWorks
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