Associated tags: Adolescence, MEK, Clinical trial, Aes, MEK1, Protein, Fatigue, Patient, BID, MAPK, Nausea, Survival, MEK2, Neurofibromatosis, Pharmaceutical industry, Peter MacCallum Cancer Centre, Doctor of Philosophy, BRAF, Mutation, Toxic leukoencephalopathy, NSCLC, Lung cancer, Part, Pharmacokinetics, Incidence, Hair, SSE, Endometrial cancer, RAS, American Association for Cancer Research, SWTX
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Pharmaceutical industry STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that four abstracts from the company's portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 to June 4, 2024.
Key Points:
- STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that four abstracts from the company's portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 to June 4, 2024.
- In addition, three new data sets from the pivotal Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors will be presented at ASCO.
- The DeFi trial developed one of the most comprehensive assessments of ovarian function in an oncology clinical trial to date.
- Of the 142 patients in the DeFi trial intent-to-treat population, 29 had identified APC mutations (nirogacestat, N=13; placebo, N=16).
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Pharmaceutical industry STAMFORD, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that data from the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31 to June 4, 2024. SpringWorks recently initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib in pediatric and adult patients with NF1-PN.
Key Points:
- STAMFORD, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that data from the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31 to June 4, 2024.
- SpringWorks recently initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib in pediatric and adult patients with NF1-PN.
- Additional data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat) in adults with desmoid tumors were also accepted for presentation at ASCO, including an abstract describing the onset and resolution of ovarian toxicity for desmoid tumor patients treated with nirogacestat, as well as two additional sub-group analyses evaluating nirogacestat in desmoid tumor patients with poor prognostic factors and in those with adenomatous polyposis coli (APC) mutations.
- “The Phase 2b ReNeu trial data are the cornerstone of our NDA for mirdametinib in NF1-PN, and we are very pleased that these data were accepted for an oral presentation at ASCO,” said Jim Cassidy, M.D., Ph.D., Chief Medical Officer of SpringWorks.
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Pharmaceutical industry Mirdametinib treatment showed deep and durable responses and demonstrated significant improvements in key secondary patient-reported outcome measures.
Key Points:
- Mirdametinib treatment showed deep and durable responses and demonstrated significant improvements in key secondary patient-reported outcome measures.
- The FDA and the European Commission have granted Orphan Drug designation for mirdametinib for the treatment of NF1.
- In July 2023, the FDA granted mirdametinib Rare Pediatric Disease designation for the treatment of NF1, which provides eligibility for a priority review voucher upon FDA approval.
- SpringWorks expects to complete the NDA submission in the second quarter of 2024.
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Pharmaceutical industry The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.
Key Points:
- The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.
- Mirdametinib was generally well tolerated in the ReNeu trial, with the majority of adverse events (AEs) being Grade 1 or Grade 2.
- “We are extremely pleased that the results of our ReNeu trial demonstrate a compelling clinical profile across measures of both safety and efficacy.
- SpringWorks plans to submit a New Drug Application (NDA) for mirdametinib to the FDA in the first half of 2024.
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FRACP The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
Key Points:
- The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
- “The lifirafenib plus mirdametinib combination represents a novel targeted approach to treat solid tumors driven by RAS/RAF mutations, and other MAPK pathway aberrations.
- As of the data cut-off of January 20, 2023, 71 patients were treated across 9 dose levels evaluating different dosing regimens.
- Of the 4 endometrial cancer patients treated, 2 (50%) had objective responses in tumors that harbor BRAF fusion mutation or KRAS mutation, respectively.
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BeiGene The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
Key Points:
- The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
- View the full release here: https://www.businesswire.com/news/home/20230417005339/en/
“The lifirafenib plus mirdametinib combination represents a novel targeted approach to treat solid tumors driven by RAS/RAF mutations, and other MAPK pathway aberrations.
- As of the data cut-off of January 20, 2023, 71 patients were treated across 9 dose levels evaluating different dosing regimens.
- Of 17 patients with LGSOC treated, 10 patients (59%) had objective responses, with median duration of treatment of approximately 26 months.
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Mirdametinib,
SpringWorks Therapeutics SpringWorks expects to initiate the ReNeu trial, a Phase 2b open-label, single-arm trial with mirdametinib that will enroll both pediatric and adult NF1-PN patients, in the third quarter of 2019.
Key Points:
- SpringWorks expects to initiate the ReNeu trial, a Phase 2b open-label, single-arm trial with mirdametinib that will enroll both pediatric and adult NF1-PN patients, in the third quarter of 2019.
- Neurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from mutations in the NF1 gene, which encodes for neurofibromin, a key suppressor of the MAPK pathway.
- Mirdametinib has been evaluated in several Phase 1 and Phase 2 clinical trials, with over 200 subjects having been exposed to treatment.
- At SpringWorks, a clinical-stage biopharmaceutical company, we are driven to develop life-changing medicines for patients with severe rare diseases and cancer.
