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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: 27 May 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

  • 21 May 2025 According to an AstraZeneca media release, data from this trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting
  • 12 Nov 2024 According to an AstraZeneca media release, Alexion, AstraZeneca Rare Disease looks forward to share the data from this study with regulatory authorities and present at a forthcoming medical meeting. AstraZeneca and MSD are jointly developing and commercialising Koselugo globally.
  • 12 Nov 2024 Primary endpoint (Confirmed Objective Response Rate (ORR) for Arm A versus Arm B) has been met, according to an AstraZeneca media release.

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