Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TX05 · 1 trial · 5 indications
Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).
| Arm | Type | Description |
|---|---|---|
| TX05 (trastuzumab) | EXPERIMENTAL | • Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles |
| Herceptin® | ACTIVE_COMPARATOR | • Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles |
| Name | Type | Description |
|---|---|---|
| TX05 (trastuzumab) | BIOLOGICAL | 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8) |
| Herceptin® | BIOLOGICAL | 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8) |
| Paclitaxel | DRUG | 175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8) |
| Epirubicin | DRUG | 75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4) |
| Cyclophosphamide | DRUG | 600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4) |
Key Inclusion Criteria: * Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria). * Available tumor tissue for central review of HER2 status. * Planned surgical resection of breast tumor. * Planned neoadjuvant chemothera...
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TX05 is an investigational monoclonal antibody being developed for the treatment of HER2-positive early breast cancer, specifically in patients with Stage II or Stage IIIA disease. It is being studied as a potential biosimilar to Herceptin (trastuzumab) in this patient population.
TX05 targets the HER2 receptor, which is overexpressed in HER2-positive breast cancer. By binding to HER2, the antibody is designed to interfere with cancer cell growth signals. The drug is being evaluated in patients whose tumors are HER2-positive, as confirmed by biomarker selection.
TX05 is being developed by BrainsWay Ltd., a company publicly traded under the ticker symbol BWAY. The company is conducting clinical research on this monoclonal antibody for the treatment of HER2-positive early breast cancer.
TX05 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled, double-blind, randomized study. The drug is still investigational and has not been approved by regulatory authorities.
TX05 has been studied in one completed Phase 3 trial, identified as NCT03556358. This trial compared the safety, efficacy, and immunogenicity of TX05 with Herceptin in patients with HER2-positive early breast cancer. The study enrolled 809 female participants across multiple countries.
TX05 is not the same as Herceptin, but it is being developed as a potential biosimilar to Herceptin (trastuzumab). The Phase 3 trial was designed to compare TX05 directly with Herceptin to assess whether TX05 is similar in terms of safety, efficacy, and immunogenicity.