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A Randomized Controlled, Multi-center Phase III Clinical Trial of AK112 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer

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Trial Profile

A Randomized Controlled, Multi-center Phase III Clinical Trial of AK112 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer

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

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Ivonescimab (Primary) ; Pembrolizumab
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HARMONi-2
  • Sponsors Akeso Biopharma

Most Recent Events

  • 25 Apr 2025 According to an Akeso Biopharma media release, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a monotherapy for the first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC). The sNDA approval is based on the breakthrough results of the HARMONi-2 Phase III study.
  • 25 Apr 2025 According to an Summit Therapeutics media release, Ivonescimab monotherapy approved by NMPA in China for Front-Line PD-L1 Positive Advanced NSCLC based on the results of the Phase III clinical trial, HARMONi-2 or AK112-303
  • 25 Apr 2025 Interim overall survival analysis from this trial presented in the Summit Therapeutics Media Release

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