SpringWorks to Present Four Abstracts, Including Mirdametinib in NF1-PN, at 2024 ASCO Annual Meeting


SpringWorks to Present Four Abstracts, Including Mirdametinib in NF1-PN, at 2024 ASCO Annual Meeting

SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) announced today that four abstracts from the company's portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 to June 4, 2024.

The four abstracts to be presented at ASCO include:

  • Results from the pivotal Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN, which will be presented in an oral presentation.
  • Monitoring ovarian function in oncology studies and the onset and resolution of ovarian toxicity for desmoid tumor patients treated with nirogacestat in the DeFi trial, which will be discussed in an oral presentation.
  • Two posters that include post hoc analyses from the DeFi trial in high-risk patient populations, which reinforce the efficacy and safety of nirogacestat in adults with desmoid tumors across various clinical characteristics.

About the ReNeu Trial

ReNeu (NCT03962543) is an ongoing, multi-center, open-label Phase 2b trial evaluating the efficacy, safety, and tolerability of mirdametinib in patients two years of age and older with an inoperable NF1-associated PN causing significant morbidity. The study enrolled 114 patients to receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily) without regard to food. Mirdametinib was administered orally in a 3-week on, 1-week off dosing schedule as either a capsule or dispersible tablet. The primary endpoint is confirmed objective response rate defined as ≥ 20% reduction in target tumor volume as measured by MRI and assessed by blinded independent central review. Secondary endpoints include safety and tolerability, duration of response, and changes from baseline in patient-reported outcomes to Cycle