SpringWorks Therapeutics Announces Presentation of Additional Data from Phase 3 DeFi Trial of Nirogacestat in Adults with Desmoid Tumors at the 2023 ASCO Annual Meeting

- Nirogacestat Treatment Demonstrated Rapid, Sustained and Consistent Reductions in Pain Compared to Placebo Using Multiple Assessment Tools -

- Substantial Reductions in MRI-Assessed Tumor Volume and T2 Hyperintensity Observed with Nirogacestat Compared to Placebo -

STAMFORD, Conn., May 25, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that additional data from the Phase 3 DeFi trial assessing the impact of nirogacestat, an investigational gamma secretase inhibitor, on pain, tumor volume and T2 hypersensitivity in adults with desmoid tumors will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023. Data from the DeFi trial were previously presented at the European Society for Medical Oncology Congress in September 2022 and published in the March 9, 2023 edition of the New England Journal of Medicine.¹

“Pain is the most debilitating symptom reported by patients living with desmoid tumors and reducing this burden is a key treatment goal for physicians. We are pleased with the robust data observed using multiple assessment tools demonstrating clinically significant reductions in pain with nirogacestat treatment,” said Jim Cassidy, M.D., Ph.D., Chief Medical Officer of SpringWorks. “We are also encouraged by the substantial reductions in tumor volume and T2 hyperintensity seen in the DeFi study, which are consistent with the significant improvements in progression-free survival and objective response rate previously reported, and further elaborate on the activity profile of nirogacestat in desmoid tumors. We believe that nirogacestat has the potential to be a significant advance for patients and we look forward to our continued discussions with the FDA as they review our New Drug Application.”

Poster Presentations at the 2023 ASCO Annual Meeting

Impact of nirogacestat on pain, a key symptom in patients with desmoid tumors (DT): results from the Phase 3 DeFi study (Poster #: 498)

Abstract #: 11564

Poster Session Date and Time: Saturday, June 3, 1:15 – 4:15 p.m. CT (2:15 – 5:15 p.m. ET)

As previously reported, in the DeFi trial (NCT03785964), nirogacestat met its primary endpoint of significantly improving progression-free survival compared to placebo in adult patients with progressing desmoid tumors (hazard ratio: 0.29 [95% CI, 0.15–0.55]; P<0.001). Nirogacestat also achieved a significant and clinically meaningful reduction in pain severity, a key secondary endpoint, compared with placebo at Cycle 10 (P<0.001). A manageable safety profile was observed with nirogacestat, with 95% of all treatment-emergent adverse events (TEAEs) reported as either Grade 1 or 2. The most frequently reported TEAEs that occurred in participants receiving nirogacestat were diarrhea (84%), nausea (54%), fatigue (51%), hypophosphatemia (42%), and maculopapular rash (32%).