Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bevacizumab as MYL-1402O · 1 trial · 1 indication
The primary efficacy endpoint Overall Response Rate (ORR) will be based on best tumor responses as assessed by an independent review at any time point during the first 18 weeks, and assessed according to RECIST 1.1. The primary efficacy analysis is based on the ratio of the MYL-1402O ORR to the Avastin ORR at Week 18 based on the Intent to Treat ( ITT) set of patients.
| Arm | Type | Description |
|---|---|---|
| MYL-1402O | EXPERIMENTAL | Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. |
| Avastin | ACTIVE_COMPARATOR | Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. |
| Name | Type | Description |
|---|---|---|
| Bevacizumab as MYL-1402O | BIOLOGICAL | Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
| Bevacizumab as Avastin | BIOLOGICAL | Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
Key Inclusion Criteria: 1. Written and signed informed consent 2. 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 3. Documented histologic or cytologic di...
MYL-1402O is a proposed biosimilar to bevacizumab, a monoclonal antibody developed by Viatris Inc. (ticker VTRS). It is being studied as a treatment for Stage IV non-small cell lung cancer (NSCLC) and is designed to be a comparable alternative to the reference product Avastin.
MYL-1402O is being developed for the treatment of Stage IV non-small cell lung cancer (NSCLC). It is a biosimilar candidate to bevacizumab, which is used in oncology. The clinical program has focused on patients with Stage IV nonsquamous NSCLC, evaluating the drug in that specific indication.
MYL-1402O targets VEGFA, vascular endothelial growth factor A. It is a monoclonal antibody that acts as an inhibitor of VEGFA. By binding to VEGFA, it is designed to interfere with the vascular endothelial growth factor pathway, which is involved in tumor angiogenesis.
MYL-1402O is being developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical development program for this bevacizumab biosimilar candidate in oncology.
MYL-1402O is in Phase 3 clinical development. It is an investigational biosimilar candidate and has not been approved by the FDA. The Phase 3 trial has been completed, and the program is focused on demonstrating comparability to the reference product Avastin.
MYL-1402O has been studied in the Phase 3 trial NCT04633564, titled MYL-1402O Compared With Avastin in Patients With Stage IV nsNSCLC. This completed trial enrolled 671 patients, was randomized, double-blind, and active-controlled, and included sites across multiple countries.
MYL-1402O is a proposed biosimilar to Avastin (bevacizumab), not the same product. It is developed by Viatris as a comparable alternative to the reference biologic. The Phase 3 trial NCT04633564 directly compared MYL-1402O with Avastin in patients with Stage IV nonsquamous NSCLC.