SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

STAMFORD, Conn., Jan. 08, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, will present today at the 42^nd Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET), and a live webcast will be available at ir.springworkstx.com. Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

2023 Accomplishments

Nirogacestat

• Received approval from the United States Food and Drug Administration (FDA) for OGSIVEO (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
• Published data from the Phase 3 DeFi trial of nirogacestat in adult patients with progressing desmoid tumors in the New England Journal of Medicine.
• Presented additional data from the Phase 3 DeFi trial at several leading medical conferences. These presentations demonstrated rapid, sustained and consistent improvements in pain and functional status in patients receiving OGSIVEO using multiple assessment tools.
• Completed enrollment in the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors (OvGCT).
• Continued to evaluate nirogacestat in patients with multiple myeloma as part of several B-cell maturation antigen (BCMA) combination therapy regimens across treatment lines in collaboration with industry leaders. Clinical data from two BCMA combination studies were presented at the European Hematology Association congress and provided further validation of the mechanistic approach supporting nirogacestat’s ability to enhance the activity of BCMA-directed therapies across modalities. In addition, a Regeneron-sponsored study was initiated to evaluate nirogacestat in combination with linvoseltamab, Regeneron’s bispecific antibody targeting BCMA and CD3.
  

Mirdametinib (NF1-PN)

• Presented positive topline data from the pivotal Phase 2b ReNeu trial evaluating mirdametinib, an investigational oral MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). Data demonstrated a confirmed objective response rate of 52% in pediatric patients and 41% in adult patients, as assessed by Blinded Independent Central Review. Mirdametinib treatment resulted in deep and durable responses and led to significant improvements in key secondary patient-reported outcome measures. Mirdametinib was generally well tolerated in the ReNeu trial, with the majority of adverse events being Grade 1 or Grade 2.