“ Results from Phase 2b ReNeu trial of mirdametinib in NF1-PN accepted for oral presentation ““ Additional data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat) in adults with desmoid...
SpringWorks Initiates Rolling Submission of NDA to the FDA for Mirdametinib
“ 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...
BeiGene and SpringWorks Present Clinical Data on Lifirafenib, in Combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023
SpringWorks and BeiGene Present Clinical Data on Lifirafenib, in combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023
STAMFORD, Conn., June 16, 2021 (GLOBE NEWSWIRE) -- 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 the initiation of a Phase 1/2 clinical trial to evaluate mirdametinib, an investigational MEK inhibitor, for the treatment of children, adolescents, and young adults with low-grade glioma (LGG). The study is sponsored by St. Jude Children’s Research Hospital. More information on the trial can be found on www.clinicaltrials.gov under the identifier NCT04923126.
STAMFORD, Conn., Feb. 25, 2021 (GLOBE NEWSWIRE) -- 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.
SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the first patient has been dosed in a Phase 1b study to evaluate the combination of SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901, and BeiGene, Ltd.’s (Nasdaq: BGNE; HKEX: 06160) investigational RAF dimer inhibitor, lifirafenib (BGB-283), in patients with advanced or refractory solid tumors.
SpringWorks Therapeutics launched in September 2017 with $103 million and a handful of clinical-stage Pfizer drugs. A year later, the startup has named its first CEO and is unveiling a partnership with BeiGene focusing on a targeted combination therapy for an “undruggable” cancer mutation.