A Phase 3 trial comparing SB27 to Keytruda (pembrolizumab) for metastatic non-squamous non-small cell lung cancer (NSCLC) reached its primary completion on March 12, 2026. The study, which enrolled 555 participants, aims to confirm the efficacy, safety, pharmacokinetics, and immunogenicity of SB27 against Keytruda.
Background
Pembrolizumab, marketed as Keytruda, is a widely used immunotherapy. This trial investigates SB27 as a potential biosimilar for Keytruda in the treatment of metastatic non-squamous non-small cell lung cancer.
Trial design
This was a Phase 3 trial (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". The study enrolled 555 participants with Non-small Cell Lung Cancer Stage IV. The trial's goal is to confirm that SB27 works in the same way as Keytruda in these patients. Participants received either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks, with researchers comparing SB27 and Keytruda.
What this means
The primary completion of this Phase 3 trial signifies the conclusion of the main data collection period for its primary endpoints. Researchers will now proceed with analyzing the collected data to assess the comparative efficacy, safety, pharmacokinetics, and immunogenicity of SB27 against Keytruda in patients with metastatic non-squamous non-small cell lung cancer. The results of this study will be crucial in determining the potential of SB27 as a biosimilar.
Source
The primary completion status for this trial was updated on March 12, 2026, on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT06348199.