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US-sourced Keytruda® / Non Squamous Non Small Cell Lung Cancer / MB12 (Proposed Pembrolizumab Biosimilar) · Phase 3 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active Phase 3 registry record for BENITO, a randomized double-blind multicenter trial designed to establish pharmacokinetic bioequivalence and clinical efficacy equivalence between MB12 (a proposed pembrolizumab biosimilar) and both EU- and US-sourced Keytruda® in combination with chemotherapy for first-line treatment of advanced/metastatic non-squamous NSCLC. No efficacy, safety, or immunogenicity results are posted; the trial is currently enrolling. Clinicians should await published results before drawing conclusions about biosimilar comparability.
Phase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Non Squamous Non Small Cell Lung Cancer; age from 18 Years. Intervention: MB12 (Proposed Pembrolizumab Biosimilar). Compared with: EU- sourced Keytruda® — Active Comparator; US- sourced Keytruda® — Active Comparator. n = 726. 173 sites across 24 countries.
This is an active Phase 3 registry record for BENITO, a randomized double-blind multicenter trial designed to establish pharmacokinetic bioequivalence and clinical efficacy equivalence between MB12 (a proposed pembrolizumab biosimilar) and both EU- and US-sourced Keytruda® in combination with chemotherapy for first-line treatment of advanced/metastatic non-squamous NSCLC. No efficacy, safety, or immunogenicity results are posted; the trial is currently enrolling. Clinicians should await published results before drawing conclusions about biosimilar comparability.
No efficacy, safety, immunogenicity, or PK data are reported in this registry record.
This trial is designed to support regulatory approval and clinical use of MB12 as a biosimilar to pembrolizumab. Clinicians should monitor for publication of results to inform treatment decisions regarding biosimilar substitution; pending results, the study does not yet change practice.
This is a Phase 3 trial registry record with no posted results; the study is actively enrolling to establish PK bioequivalence and efficacy similarity of a proposed biosimilar, making it an ongoing comparative effectiveness study without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This trial is designed to support regulatory approval and clinical use of MB12 as a biosimilar to pembrolizumab. Clinicians should monitor for publication of results to inform treatment decisions regarding biosimilar substitution; pending results, the study does not yet change practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06687369). This is a study registration, not published results. Lead sponsor: mAbxience Research S.L.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 726 participants (ESTIMATED). Conditions: Non Squamous Non Small Cell Lung Cancer. Interventions: DRUG: MB12 (Proposed Pembrolizumab Biosimilar); DRUG: EU-sourced Keytruda®; DRUG: US-sourced Keytruda®; DRUG: Pemetrexed; DRUG: Carboplatin; DRUG: Cisplatin. Primary outcome measures: To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy , Week 1 - Week 24; To demonstrate the efficacy equivalence of MB12 and Keytruda® in combination with chemotherapy administered as first-line treatment in patients with advanced/metastatic non-squamous NSCLC (any PD-L1 expression type). , Week 1 - Week 24. Brief summary: This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.