{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T09:36:09Z","timestamp":1793093769111,"version":"4.5.0"},"reference-count":38,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"6","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,2,20]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>Pharmacologic therapies for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PNs) are limited; currently, none are US Food and Drug Administration\u2013approved for adults.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>\n              ReNeu is an open-label, multicenter, pivotal, phase IIb trial of mirdametinib in 58 adults (\u226518 years of age) and 56 children (2 to 17 years of age) with NF1-PN causing significant morbidities. Patients received mirdametinib capsules or tablets for oral suspension (2 mg\/m\n              <jats:sup>2<\/jats:sup>\n              twice daily, maximum 4 mg twice daily), regardless of food intake, in 3 weeks on\/1 week off 28-day cycles. The primary end point was confirmed objective response rate (ORR; proportion of patients with a \u226520% reduction of target PN volume from baseline on consecutive scans during the 24-cycle treatment phase) assessed by blinded independent central review (BICR) of volumetric magnetic resonance imaging.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>Twenty-four of 58 adults (41%) and 29 of 56 children (52%) had a BICR-confirmed objective response during the 24-cycle treatment phase; in addition, two adults and one child had confirmed responses during long-term follow-up. Median (range) target PN volumetric best response was \u201341% (\u221290 to 13) in adults and \u201342% (\u221291 to 48) in children. Both cohorts reported significant and clinically meaningful improvement in patient- or parent proxy-reported outcome measures of worst tumor pain severity, pain interference, and health-related quality of life (HRQOL) that began early and were sustained during treatment. The most commonly reported treatment-related adverse events were dermatitis acneiform, diarrhea, and nausea in adults and dermatitis acneiform, diarrhea, and paronychia in children.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>In ReNeu, the largest multicenter NF1-PN trial reported to date, mirdametinib treatment demonstrated significant confirmed ORRs by BICR, deep and durable PN volume reductions, and early, sustained, and clinically meaningful improvement in pain and HRQOL. Mirdametinib was well-tolerated in adults and children.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco.24.01034","type":"journal-article","created":{"date-parts":[[2024,11,8]],"date-time":"2024-11-08T20:59:09Z","timestamp":1731099549000},"page":"716-729","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":119,"title":["ReNeu: A Pivotal, Phase IIb Trial of Mirdametinib in Adults and Children With Symptomatic Neurofibromatosis Type 1-Associated Plexiform Neurofibroma"],"prefix":"10.1200","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct03962543","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5474-588X","authenticated-orcid":true,"given":"Christopher L.","family":"Moertel","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of Minnesota, Minneapolis, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1719-0771","authenticated-orcid":true,"given":"Angela C.","family":"Hirbe","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine in St Louis, St Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans H.","family":"Shuhaiber","sequence":"additional","affiliation":[{"name":"University of Florida Clinical Research Center, Gainesville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Bielamowicz","sequence":"additional","affiliation":[{"name":"The University of Arkansas for Medical Sciences\/Arkansas Children's Hospital, Little Rock, AR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alpa","family":"Sidhu","sequence":"additional","affiliation":[{"name":"University of Iowa Hospitals and Clinics, Iowa City, IA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Viskochil","sequence":"additional","affiliation":[{"name":"University of Utah, Salt Lake City, UT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael D.","family":"Weber","sequence":"additional","affiliation":[{"name":"SpringWorks Therapeutics, Inc, Stamford, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armend","family":"Lokku","sequence":"additional","affiliation":[{"name":"SpringWorks Therapeutics, Inc, Stamford, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. 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