Pembrolizumab Biosimilar Phase 3 Trial Reaches Primary Completion

ClinicalTrials.gov recorded primary completion on 31 August 2026 for a Phase 3 study comparing MB12, a proposed pembrolizumab biosimilar, with Keytruda in non-squamous non-small cell lung cancer. The randomized trial enrolled 726 participants and was designed to compare pharmacokinetics, efficacy, safety, and immunogenicity.

Background

The BENITO Study evaluated MB12 against Keytruda, the pembrolizumab reference product, in patients with metastatic non-squamous non-small cell lung cancer. The study examined MB12 in combination with pemetrexed and platinum chemotherapy as first-line treatment. The registered treatment options included MB12, European Union-sourced Keytruda, United States-sourced Keytruda, pemetrexed, and carboplatin.

Trial design

This was a Phase 3, randomized, multicenter, multinational, double-blind, integrated pharmacokinetics and efficacy similarity study. It enrolled 726 participants with non-squamous non-small cell lung cancer. The trial compared MB12 with Keytruda in combination with pemetrexed-platinum chemotherapy for first-line treatment of metastatic disease. The ClinicalTrials.gov record listed the overall status as recruiting at the time represented in the supplied data.

The study objectives were to compare pharmacokinetics, efficacy, safety, and immunogenicity between MB12 and Keytruda. The record identified the BENITO Study as NCT06687369. No primary outcome entries, outcome measurements, statistical analyses, or adverse-event summary were supplied.

What this means

Primary completion marks the point at which the trial’s primary data-collection stage was recorded as complete. The supplied record establishes that the study was designed to assess similarity between MB12 and Keytruda across pharmacokinetic, efficacy, safety, and immunogenicity measures in this lung cancer setting.

However, the available data do not report treatment results, response measures, pharmacokinetic values, confidence intervals, p-values, or comparative adverse events. They therefore do not establish whether MB12 met a similarity endpoint, demonstrate a safety difference, or indicate a new approval or change to pembrolizumab’s clinical use.

Source

Source: ClinicalTrials.gov, registry record for the BENITO Study, NCT06687369, with the primary-completion event dated 31 August 2026. The record is available at clinicaltrials.gov/study/NCT06687369.