SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow

Nirogacestat in Desmoid Tumors - The FDA accepted the NDA submission for Nirogacestat in desmoid tumors in Q1 2023 with Priority Review, with a PDUFA date of August 27, 2023 [61] - Desmoid tumor recurrence can be up to 77% following surgery [67] - In the Phase 3 DeFi trial, the objective response rate (ORR) for Nirogacestat was 41%, compared to 8% for placebo (p<0001) [90] - The Phase 3 DeFi trial demonstrated a 71% reduction in the risk of disease progression with Nirogacestat (hazard ratio: 029, p<0001) [140] - Among women of childbearing potential, ovarian dysfunction (OD) was observed in 75% receiving nirogacestat [119] Mirdametinib in NF1-PN - Topline data from the Phase 2b ReNeu trial in NF1-PN is expected in 2H 2023 [163] - NF1 patients have a ~30-50% lifetime risk of developing NF1-PN [151] - In the ReNeu trial, 50% of adult patients achieved an objective response by BICR [170] MAPK Portfolio - Approximately 25% of ER+ mBC patients progress on endocrine therapy [2] - Class 1 and 2 MEK mutants are sensitive to Mirdametinib in vitro [3] - BGB-3245 is active against resistance mutations that arise in BRAF V600 patients treated with approved BRAF inhibitors [270]