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A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) As an Add-on to Chemotherapy in Treatment-naïve Patients with Metastatic Non-squamous Non-small Cell Lung Cancer

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A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) As an Add-on to Chemotherapy in Treatment-naïve Patients with Metastatic Non-squamous Non-small Cell Lung Cancer

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms Lotus
  • Sponsors Formycon

    • Most Recent Events

    • 17 Feb 2025 Status changed from recruiting to discontinued, according to a Formycon AG media release.
    • 17 Feb 2025 According to a Formycon AG media release, the company has decided to terminate this trial based on intensive scientific dialogue with the US FDA, continuation of the trial is no longer necessary for the development and approval therapeutic comparability of FYB206 with the reference drug Keytruda can be sufficiently demonstrated based on comprehensive analytical data and the data from Dahlia. Patient treated in this trial so far will continue to be given the reference Keytruda.
    • 02 Aug 2024 Status changed from planning to recruiting.

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