Pembrolizumab Biosimilar Trial for Metastatic NSCLC Completes Primary Phase

By Hipa.ai Research · March 16, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

A Phase 3 clinical trial comparing GME751 to EU-authorized Keytruda (pembrolizumab) for adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC) completed its primary phase on 2026-03-16. The study, which enrolled 218 participants, aims to evaluate the efficacy, safety, and immunogenicity of GME751.

Background

The study investigates GME751 in comparison to Keytruda (pembrolizumab), a widely used immunotherapy for various cancers, including non-small cell lung cancer. This trial specifically focuses on adult participants with untreated metastatic non-squamous NSCLC.

Trial design

The study, identified as NCT06159790, is a Phase 3 trial designed to assess the efficacy, safety, and immunogenicity of GME751 against EU-authorized Keytruda (pembrolizumab). It enrolled 218 adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC). Participants were included irrespective of PD-L1 status and excluded if they had sensitizing EGFR or ALK mutations. The trial's primary completion indicates that the final data for the primary outcome measures have been collected.

What this means

The primary completion of this Phase 3 study marks a significant milestone in the development of GME751. As a comparative trial against EU-authorized Keytruda, its results, once available, will be crucial for understanding the potential of GME751 as an alternative treatment option for patients with untreated metastatic non-squamous NSCLC. Data on efficacy, safety, and immunogenicity will inform future regulatory decisions and clinical practice regarding this patient population.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06159790, titled "A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)," was updated to reflect primary completion on 2026-03-16 on clinicaltrials.gov.