- SpringWorks Therapeutics Inc (NASDAQ:SWTX) has announced positive topline results from the DeFi Phase 3 trial evaluating nirogacestat in adult patients with progressing desmoid tumors.
- Desmoid tumors are noncancerous growths occurring in the connective tissue, most often in the abdomen, arms, and legs.
- The DeFi trial met its primary endpoint of improving progression-free survival, demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression.
- Also Read: AbbVie, SpringWorks Join Forces To Conduct Multiple Myeloma Combo Therapy Trial.
- In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate and patient-reported outcomes.
- Nirogacestat was generally well tolerated with a manageable safety profile.
- SpringWorks plans to submit a marketing application to the FDA in 2H of 2022.
- Nirogacestat has received Orphan Drug Designation from the FDA for desmoid tumors and from the European Commission to treat soft tissue sarcoma.
- The FDA also granted Fast Track and Breakthrough Therapy Designations for adult patients with progressive, unresectable, recurrent, refractory desmoid tumors or deep fibromatosis.
- Price Action: SWTX shares are up 18.8% at $44.94 during the premarket session on the last check Tuesday.
