Keytruda Phase 3 Biosimilar Trial for Metastatic NSCLC Reaches Primary…

By Hipa.ai Research · March 31, 2026

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

The Phase 3 clinical trial comparing SB27 to Keytruda (pembrolizumab) in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) reached its primary completion on March 31, 2026. This study, which enrolled 555 participants, aims to confirm the comparable efficacy, safety, pharmacokinetics, and immunogenicity of SB27 against Keytruda.

Background

The study focuses on Keytruda (pembrolizumab), an established treatment, and its comparison with SB27. The trial specifically addresses patients with metastatic non-squamous non-small cell lung cancer (NSCLC) Stage IV.

Trial design

The study, identified as NCT06348199, is a Phase 3 clinical trial designed to compare SB27 and Keytruda. It enrolled 555 participants diagnosed with metastatic non-squamous non-small cell lung cancer (NSCLC) Stage IV. The trial's primary goal is to confirm that SB27 works in the same way as Keytruda, evaluating efficacy, safety, pharmacokinetics, and immunogenicity. Participants receive either the investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.

What this means

The primary completion of this Phase 3 trial marks a significant milestone in the development of SB27 as a potential biosimilar to Keytruda (pembrolizumab). For patients with metastatic non-squamous non-small cell lung cancer, the availability of biosimilar options could potentially increase access to treatment and reduce healthcare costs. The trial's completion indicates that the necessary data collection for its primary endpoints has concluded, moving it closer to potential regulatory review once results are analyzed and published.

Source

Information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06348199, titled "A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer," was updated to reflect primary completion on March 31, 2026, on clinicaltrials.gov.