A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)

Launched by MABXIENCE RESEARCH S.L. · Nov 12, 2024

Keywords

ClinConnect Summary

The BENITO Study is a clinical trial designed to compare a new treatment called MB12, which is a proposed biosimilar to Keytruda®, for patients with advanced non-small cell lung cancer (NSCLC). This study aims to find out how well MB12 works, how safe it is, and how it behaves in the body compared to Keytruda® when given alongside a specific chemotherapy regimen. The trial is currently recruiting participants who are adults aged 18 and older and have been diagnosed with stage IV non-squamous NSCLC that has not been treated before.

To be eligible, participants should have measurable cancer lesions and a good performance status, meaning they can carry out daily activities with minimal assistance. However, individuals with certain types of lung cancer or specific medical conditions, such as a history of brain metastases or recent major surgery, may not qualify. Those who join the trial can expect to receive treatment in a controlled setting and will be monitored closely for their response and any potential side effects. This study is an important step in understanding how this new treatment option may benefit patients with advanced lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult male/female patients ≥18 years old at the time of signing the informed consent form (ICF).
• • 2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \[TNM\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
• • 3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.
• • 4. Known status of PD-L1 expression.
• • 5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• • 6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.
• Exclusion Criteria:
• • 1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.
• • 2. Known history of central nervous system metastases and/or carcinomatous meningitis.
• • 3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).
• • 4. Major surgery within 3 weeks of the first dose of study treatment.
• • 5. Active autoimmune disease that has required systemic treatment in the last 2 years.
• • 6. Contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.
• • 7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.