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A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET)

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Trial Profile

A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2025

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At a glance

  • Drugs Selumetinib (Primary)
  • Indications Neurofibromatosis 1; Plexiform neurofibroma
  • Focus Registrational; Therapeutic Use
  • Acronyms KOMET
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 28 Oct 2025 According to an AstraZeneca media release, Prof. Pierre Wolkenstein, MD, PhD, Head of the Department of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), is the National Coordinating Investigator of the KOMET trial in Europe.
  • 28 Oct 2025 According to an AstraZeneca media release, results from this trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The Lancet.
  • 28 Oct 2025 According to an AstraZeneca media release, based on results from KOMET, Koselugo has been approved in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).

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