Keytruda Biosimilar FYB206 Phase 3 Primary Completion for Non-squamous NSCLC

By Hipa.ai Research · May 13, 2025

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The Phase 3 trial for FYB206, a biosimilar to Keytruda (pembrolizumab), completed its primary data collection on 2025-05-13. This study (NCT06643117) investigated the biosimilar as an add-on to chemotherapy in patients with non-squamous non-small cell lung cancer (NSCLC), with the aim of demonstrating similar efficacy, safety, and immunogenicity compared to Keytruda.

Background

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. It can be treated with radiation therapy, medicines, surgery, or immunotherapy. Immunotherapy, such as pembrolizumab (Keytruda), works by helping the immune system fight cancer cells. Some cancer cells develop ways to hide from the immune system, and pembrolizumab helps the immune system target these cells. This trial investigated FYB206 as a biosimilar to pembrolizumab.

Trial design

The PHASE3 study (NCT06643117) was designed to evaluate the efficacy, safety, and immunogenicity of FYB206 in comparison to Keytruda as an add-on to chemotherapy. The trial enrolled 25 participants with Non-squamous Non-small Cell Lung Cancer (NSCLC). Participants received either FYB206 or Keytruda.

What this means

The primary completion of this Phase 3 trial signifies that data collection for the study comparing FYB206 to Keytruda in non-squamous NSCLC is complete. The trial's objective is to establish similar efficacy, safety, and immunogenicity between the biosimilar and the reference product. Future analysis and disclosure of the trial results will be critical to determine if FYB206 successfully meets these biosimilarity criteria, potentially offering an alternative treatment option for patients.

Source

Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The study record for NCT06643117, titled "Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC)," was updated on 2025-05-13 on clinicaltrials.gov.