Investors & Media Contact Us Linkedin Twitter Who We Are Focus Areas Pipeline Patients Careers Nirogacesat (Gamma Secretase Inhibitor) We measure ourselves by the impact we have on people with cancer. Let’s go big. Nirogacestat is an oral, selective, small molecule gamma secretase inhibitor (GSI) in Phase 3 clinical development as a monotherapy for patients with desmoid tumors and is being evaluated in multiple studies as a potential cornerstone of BCMA combination therapy. Nirogacestat (gamma secretase inhibitor) Gamma secretase is a protease complex that cleaves multiple transmembrane proteins, including Notch, which, when dysregulated, can play a role in activating pathways that contribute to desmoid tumor growth. A Phase 1 study was conducted in 64 patients with advanced solid tumors, of which there were seven evaluable patients who had a diagnosis of desmoid tumor. Of these seven patients, five had an objective tumor response (defined as > 30% tumor reduction). Nirogacestat was generally well tolerated. A Phase 2 open-label, investigator-initiated study sponsored by the National Cancer Institute (NCI) enrolled 17 desmoid tumor patients. Sixteen patients were evaluable for tumor response. Five patients had a confirmed partial response and 11 had stable disease. Symptomatic improvement was also reported in some patients. Nirogacestat was generally well tolerated; the most common adverse events were diarrhea, skin disorders and hypophosphatemia. A Phase 1b clinical trial is evaluating nirogacestat in combination with GSK’s BLENREP, an anti BCMA antibody-drug conjugate, in patients with relapsed or refractory multiple myeloma. A Phase 1 clinical trial is evaluating nirogacestat in combination with Janssen’s teclistamab, an investigational bispecific antibody targeting BCMA and CD3, in patients with relapsed or refractory multiple myeloma. A Phase 1b/2 clinical trial is planned to evaluate nirogacestat in combination with Pfizer’s elranatamab, an investigational BCMA CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma. A Phase 1 clinical trial is evaluating nirogacestat in combination with Allogene’s ALLO-715, an investigational BCMA AlloCAR T therapy, in patients with relapsed or refractory multiple myeloma. A Phase 1 clinical trial is evaluating nirogacestat in combination with Precision Biosciences’ PBCAR269A, an investigational BCMA allogeneic CAR T cell therapy, in patients with relapsed or refractory multiple myeloma. A Phase 1 clinical trial is planned to evaluate nirogacestat in combination with Seagen’s SEA-BCMA, an investigational monoclonal antibody targeting BCMA, in patients with relapsed or refractory multiple myeloma. Linkedin Twitter Who We Are Leadership & Board Mission & Values Partners & Collaborators Focus Areas Rare Oncology BCMA Combinations in Multiple Myeloma Biomarker-Defined Metastatic Solid Tumors Pipeline Nirogacestat Mirdametinib Clinical Trials Investigator-Initiated Research Careers View Opportunities Patients Desmoid Tumors NF1-PN Expanded Access Contact Investors & Media Press Releases Events & Presentations Corporate Governance Financial Information Stock Information Investor Resources © 2021 SpringWorks Therapeutics. All rights reserved. Privacy Policy Terms of Use By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookies Settings Reject All Accept All Cookies