This is a multicenter, open-label, randomized clinical study assessing the pharmacokinetic equivalence, pharmacodynamics, efficacy and safety of the biosimilar study drug in patients with metastatic colorectal cancer as compared with the reference drug.
This study was approved by the Ministry of Healthcare of the Russian Federation on February 14, 2012. The first-patient-in milestone was reached in April 2013, while the last-patient-out milestone was achieved in October 2014.
A total of 9 investigational sites were initiated in Russia for the study with 81 patient enrolled and 72 patients randomized.
The primary objectives of the study were to demonstrate the pharmacokinetic and pharmacodynamic equivalence of the study drug as compared to the reference drug, to assess the therapeutic efficacy and clinical safety of the study drug.
Human vascular endothelial growth factor (VEGF) is a key regulator of angiogenesis in normal and pathological conditions, as well as in tumor growth. VEGF expression is very low in healthy tissues and increased in most tumors; it correlates with tumor progression and patient survival in various types of cancer. Neutralization of VEGF biological activity decreases the vascularization and inhibits tumor growth. The active substance of the drug consists of recombinant humanized monoclonal antibodies to human vascular endothelial growth factor (VEGF). These antibodies inhibit binding of VEGF to its receptors on the surface of endothelial cells thus decreasing the vascularization, inhibiting tumor growth and metastasis.
The study drug is a biosimilar of another well-known drug, a monoclonal antibody which specifically binds and neutralizes VEGF. The efficacy and safety of this drug in patients with cancer has been proven in large clinical trials. This drug is approved for the treatment of various cancer diseases in many countries around the world, as well as in USA, EU countries and Russia. In Russia, the drug is approved for the treatment of metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced nonresectable metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, and glioblastoma.
Preclinical studies have demonstrated a high similarity of the biosimilar to the original drug in its composition, physical and chemical properties, specific activity and safety of use. No clinical studies of this investigational drug have been conducted so far.