Approval Probability
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ML Risk
Label indication Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-authorized companion diagnostic for Herceptin ( 1 , 2.2 ). FDA label
Also known as Hercules, Herceptin EU, Herceptin US
Trastuzumab · 2 trials · 2 indications
Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm.Partial Response (PR): \>/= 30% decrease sum of the diameters of target lesions from baseline sum diameters. Progressive Disease (PD): \</= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions\* denotes disease progression. Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized Cmax based on the equivalence criterion that Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-last based on the equivalence criterion that AUC0-last least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-∞, based on the equivalence criterion that AUC0-∞ least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
| Arm | Type | Description |
|---|---|---|
| Herceptin© + Taxane | ACTIVE_COMPARATOR | Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint. Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal . |
| MYL- 1401O + Taxane | EXPERIMENTAL | Part 1:MYL-1401O Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint. Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to MYL-1401O alone once every 3 weeks until DP or subject withdrawal. |
| Treatment A | EXPERIMENTAL | Hercules: 8 mg/kg i.v. infusion over 90 minutes |
| Treatment B | ACTIVE_COMPARATOR | Herceptin EU: 8 mg/kg i.v. infusion over 90 minutes |
| Treatment C | ACTIVE_COMPARATOR | Herceptin US: 8 mg/kg i.v. infusion over 90 minutes |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | BIOLOGICAL | Trastuzumab 8mg/kg Iv over 90 minutes x 1 then Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks |
| MYL- 1401O | BIOLOGICAL | MYL-1401O 8mg/kg Iv over 90 minutes x 1 then HERMyl 1401O Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks |
| Paclitaxel | DRUG | Paclitaxel 80mg/m2 IV over 60 minutes weekly. |
| Docetaxel | DRUG | Docetaxel 75mg/m2 IV over 60 minutes on day 1 of a 3 week cycle |
| Hercules | BIOLOGICAL | Powder Concentrate for Intravenous Infusion, 150 mg/vial |
| Herceptin EU | BIOLOGICAL | Powder for Concentrate for Solution for Infusion, 150 mg/vial |
| Herceptin US | BIOLOGICAL | Intravenous Infusion, 440 mg/vial |
Inclusion Criteria: Locally recurrent or MBC that is not amenable to curative surgery and/or radiation. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio \>2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined ...
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Trastuzumab is used for the treatment of breast cancer. It is an oncology therapy studied in patients with ERBB2-positive disease, and the clinical program in this asset focused on first-line treatment of metastatic breast cancer in combination with a taxane. It is a monoclonal antibody given to adults.
Trastuzumab targets ERBB2, also known as HER2, and acts as an inhibitor of that receptor. By binding ERBB2, the monoclonal antibody interferes with signaling driven by this receptor, which is why the therapy is directed at tumors that overexpress or amplify ERBB2, a biomarker-selected population.
Trastuzumab is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical program for this asset, including the Phase 3 study conducted in patients with metastatic breast cancer.
Trastuzumab is in Phase 3 clinical development for breast cancer. The Phase 3 trial in this program has been completed, and the asset remains an investigational therapy rather than a marketed product based on this development record.
Trastuzumab was evaluated in the Phase 3 trial NCT02472964, titled Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin + Taxane for 1st Line, Met. Br. Ca. That completed study enrolled 500 adults with breast cancer across Brazil, Chile, Georgia, Hungary, India, Latvia, Peru, Romania, Russia, Serbia, Slovakia, South Africa, Thailand, Turkey, and Ukraine.
The Phase 3 trial NCT02472964 was a randomized, double-blind, active-controlled study comparing trastuzumab plus a taxane against Herceptin plus a taxane in first-line metastatic breast cancer. It enrolled 500 patients aged 18 years and older of all sexes, and it was biomarker selected for ERBB2-positive disease.