SpringWorks Therapeutics Shows Early Action In Peripheral Nerves Tumor Study

  • SpringWorks Therapeutics Inc (NASDAQ: SWTX) reports interim data from the first 20 adult patients in its ongoing Phase 2b ReNeu trial evaluating mirdametinib for NF1-associated plexiform neurofibromas (NF1-PN).
  • NF1, also called von Recklinghausen's disease, is a genetic disorder characterized by the development of multiple noncancerous (benign) tumors of nerves and skin (neurofibromas) and areas of abnormal skin color (pigmentation).
  • As of the 22 January cutoff date, 50% (10 out of 20) of these patients had achieved an objective response, defined as more than 20% reduction in target tumor volume measured by MRI.
  • For seven of the ten patients who achieved an initial objective response, subsequent scheduled scans were available, and six of these seven patients had confirmed responses.
  • 16 patients remained on the study, and the median time on treatment was 10.1 cycles (approximately 10 months).
  • Mirdametinib was also generally well tolerated, with most treatment-related adverse events (TRAE) being mild or moderate. Only one severe adverse event was reported. The most common TRAEs were rash, nausea, and diarrhea.
  • The company highlighted that trial had reached approximately 70% of its target enrollment of 100 patients. The enrollment would complete in the second half of 2021.
  • Additional data from the study will be shared at a future medical conference this year.
  • Mirdametinib inhibits MEK1 and MEK2 proteins that occupy a pivotal position in the MAPK pathway, a key signaling network regulating cell growth and survival.
  • SpringWorks will host a conference call and webcast today at 8:30 a.m. ET.
  • Price Action: SWTX closed 3.5% higher at $93.59 on Wednesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsFDAGeneralnerve tumor
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!