Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Trastuzumab, MYL- 1401O
Hercules · 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 ...
Hercules is an investigational monoclonal antibody developed by Viatris Inc. (ticker VTRS). It has been studied in a Phase 1 clinical trial involving healthy adult male volunteers. The specific disease or condition Hercules is intended to treat has not been disclosed.
Hercules is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the Phase 1 clinical study of Hercules listed on ClinicalTrials.gov.
Hercules is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for Hercules.
Hercules has been evaluated in one completed Phase 1 trial, NCT02594761, titled "Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion." The trial enrolled 132 healthy male volunteers aged 18 years and older and used a randomized, double-blind, active-controlled design.
The completed Phase 1 trial for Hercules, NCT02594761, is titled as a study of trastuzumab administered as a single intravenous infusion. This indicates Hercules is associated with trastuzumab in that trial record. Trastuzumab is a monoclonal antibody, matching the modality listed for Hercules.