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SpringWorks Therapeutics Shows Early Action In Peripheral Nerves Tumor Study

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  • 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.

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