SpringWorks Therapeutics, Inc. announced that data from two collaborator-sponsored clinical studies evaluating nirogacestat, an investigational oral gamma secretase inhibitor, in combination with B-cell maturation agent (BCMA) therapies in patients with relapsed or refractory multiple myeloma (RRMM) will be presented at the European Hematology Association (EHA) 2023 Congress, taking place in Frankfurt, Germany from June 8-11, 2023. Updated clinical data from the Phase 1b clinical trial sponsored by Janssen Research & Development, LLC (Janssen) evaluating nirogacestat in combination with teclistamab, Janssen's bispecific antibody targeting BCMA and CD3, will be presented in an oral presentation. These data provide further validation of the mechanistic approach supporting nirogacestat's ability to enhance the activity of BCMA-directed therapies across modalities.

teclistamab 720 mg/kg weekly plus once daily nirogacestat 100 mg starting after teclistamab step-up dosing (n=7); and 3) 1500 mg/kg (which is the FDA-approved dose) weekly plus once daily nirogACestat 100 mg starting after Teclistamab step- up dosing (n=13). The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for nirogacestat for the treatment of adults with desmoid tumors, which is being reviewed under the FDA's Real-Time Oncology Review program. The FDA also granted Fast Track and Breakthrough Therapy Designations to nirogacestat for The treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

In addition, nirogacestat has received Orphan Drug Designation from the FDA for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically.