SpringWorks Therapeutics Inc. (SWTX) Reports Interim Data from Phase 2b ReNeu Trial of Mirdametinib for Patients with NF1-PN and Provides Trial Update

February 25, 2021 6:54 AM EST

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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported interim data from the first 20 adult patients enrolled in the ongoing Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). As of the January 22nd data cutoff date, 10/20 (50%) of these patients had achieved an objective response, as assessed by blinded independent central review (BICR), 16/20 (80%) remained on study, and the median time on treatment was 10.1 cycles (approximately 10 months). Mirdametinib was also generally well tolerated, with the majority of treatment related adverse events (TRAE) being Grade 1 or 2 and only one Grade 3 TRAE; there have been no Grade 4 or 5 adverse events (AE). SpringWorks also provided an update on the enrollment status of ReNeu, highlighting that the trial has reached approximately 70% of its target enrollment of 100 patients and that full enrollment is expected in the second half of 2021.

“We are very encouraged by these emerging data from our ongoing ReNeu trial, as they reaffirm our belief that mirdametinib has the potential to be a best-in-class treatment for patients with NF1-PN,” said Saqib Islam, Chief Executive Officer of SpringWorks. “The robust response rate, which was assessed by blinded independent central review, and the very encouraging tolerability profile observed in these interim data are particularly compelling given the unmet need among NF1-PN patients for a therapy that can provide durable efficacy while maintaining a safety profile that is suitable for long-term dosing. We look forward to completing enrollment in the ReNeu trial in the second half of this year and sharing additional data from the study at a future medical conference in 2021.”

Interim Phase 2b Data from ReNeu Trial:

The interim Phase 2b ReNeu data set for the first 20 adult patients enrolled utilized a January 22, 2021 data cutoff. Objective responses were defined as a ≥ 20% reduction in target tumor volume measured by MRI and were assessed by BICR. Patients received mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose: 4 mg twice daily) without regard to food on a three weeks-on, one week-off intermittent schedule, with patients being allowed to stay on treatment for up to 24 cycles (approximately two years). The median time on treatment for the 20 adult patients evaluated for this analysis was 10.1 cycles (approximately 10 months), with an initial efficacy assessment performed following cycle five and then every four cycles thereafter.

The preliminary efficacy and safety analysis showed:

  • 10/20 (50%) of patients had achieved an objective response by BICR.
  • For seven of the 10 patients who achieved an initial objective response, subsequent scheduled scans were available, and six of these seven patients had confirmed responses.
  • 16/20 (80%) of these patients remain on study and only one patient required a dose reduction due to an AE. Reasons for discontinuation included one each of progressive disease, participant decision, AE (Grade 1 diarrhea), and a patient being unable to undergo required MRI imaging due to a titanium rod implant from non-treatment-related worsening of scoliosis.
  • A generally well-tolerated safety profile. The majority of TRAEs were Grade 1 or 2 with only one Grade 3 TRAE reported. No Grade 4 or 5 AEs have been reported. The most common TRAEs were rash, nausea and diarrhea.

Conference Call and Webcast:SpringWorks will host a conference call and webcast today, Thursday, February 25, 2021, at 8:30 a.m. Eastern Time to discuss the ReNeu trial data and program update. Participants can listen to the call by dialing +1 (800) 708-4539 (domestic) or +1 (847) 619-6396 (international) and providing the confirmation number 50110177. A live webcast presentation can be accessed through the “Investors & Media” section of the Company’s website at https://ir.springworkstx.com/. A replay of the webcast will be available on the SpringWorks website for a limited time following the event.



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