MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

MYL-1402O is a monoclonal antibody currently being developed by Mylan GmbH, as a proposed biosimilar to European Union and US licensed Avastin (hereafter referred to as Avastin), which is approved as first line treatment in combination with carboplatin and paclitaxel (CP) for patients with Stage IV unresectable, recurrent or metastatic nsNSCLC. This randomized equivalence study is designed to meet the global regulatory requirement for approval of a biosimilar product. For this study, both MYL-1402O and Avastin are considered investigational medicinal products (IMP).

Key Inclusion Criteria:

• Written and signed informed consent
• Male or female at least 18 years of age with documented imaging diagnosis of Stage IV unresectable, recurrent or metastatic nsNSCLC with at least one measurable lesion as defined by RECIST 1.1
• Documented histologic or cytologic diagnosis of advanced nsNSCLC with negative or unknown sensitizing epidermal growth factor receptor (EGFR) mutation, and negative or unknown echinoderm microtubule-associated protein like 4 anaplastic lymphoma kinase (EML4 ALK) rearrangement.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Has not received any prior systemic therapy for first-line treatment of advanced lung cancer, except adjuvant chemotherapy, and remained disease-free for at least 12 months from time of surgery, and at least 6 months from last dose of chemotherapy.
• Treated and stable brain metastasis.

Key Exclusion Criteria:

• Documented squamous NSCLC or small cell type or large cell neuroendocrine histology
• History of significant hemoptysis, central tumors with proximity to large vessels and tumor with cavitation
• Received prior treatment with paclitaxel, bevacizumab or anthracycline or had known hypersensitivity to any of these components.
• Recent significant cardiac condition or vascular event or inadequately controlled hypertension.
• On anticoagulant therapy not considered stable
• Risk of hemorrhage in the central nervous system
• Recent history of surgery, nonhealing wound, active ulcer, or untreated bone fracture.
• History of gastrointestinal fistula, perforation, or abscess.