SpringWorks Therapeutics Inc. (SWTX) Reports Presentation of Phase 3 DeFi Data at the European Society for Medical Oncology (ESMO) Congress 2022
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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 data from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022. The abstract is expected to be published online via the ESMO website on September 8, 2022 (12:05 a.m. CEST; 6:05 p.m. ET on September 7).
“We are very pleased that the DeFi trial was selected as a late-breaking oral presentation at ESMO,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We look forward to sharing the detailed DeFi results at the conference and to filing our NDA before the end of the year, which will be reviewed under the FDA’s Real-Time Oncology Review program.”
ESMO Oral Presentation Details
Title: DeFi: A Phase 3, Randomized Controlled Trial of Nirogacestat Versus Placebo for Progressing Desmoid Tumors (DT) Presentation Number: LBA2 Presenter: Bernd Kasper, M.D., Ph.D., University of Heidelberg, Mannheim University Medical Center, Mannheim Cancer Center, Sarcoma Unit, Mannheim, GermanySession/Type: Presidential Symposium 1, Proffered Paper SessionDate: Saturday, September 10, 2022 Time: 16:55 – 17:10 CEST (10:55-11:10 a.m. ET)
SpringWorks will host conference call to discuss the DeFi data and next steps on the program (details to follow).
About the DeFi Trial
DeFi (NCT03785964) is an ongoing, global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors. The study randomized 142 patients to receive 150 mg of nirogacestat or placebo twice daily. Key eligibility criteria included tumor progression by >20% as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) within 12 months prior to the first dose of study treatment. The primary endpoint is progression-free survival, as assessed by blinded independent central review. Secondary and exploratory endpoints include safety and tolerability measures, objective response rate (ORR), duration of response, changes in tumor volume assessed by magnetic resonance imaging (MRI), and changes in patient-reported outcomes (PROs).