Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HD204 · 2 trials · 3 indications
Percent patients within each treatment group who achieved complete response (CR) or partial response (PR) by the time of the Week 18 efficacy analysis in accordance with the RECIST 1.1. as assessed by CIR.
Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin
| Arm | Type | Description |
|---|---|---|
| HD204 (Bevacizumab biosimilar) | EXPERIMENTAL | HD204 + Carboplatin/Paclitaxel |
| Avastin (Bevacizumab) | ACTIVE_COMPARATOR | Avastin® + Carboplatin/Paclitaxel |
| HD204 | EXPERIMENTAL | Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
| EU-licensed Avastin | ACTIVE_COMPARATOR | Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
| US-licensed Avastin | ACTIVE_COMPARATOR | Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | 15 mg/kg IV every 3 weeks on Day 1 |
| HD204 | DRUG | 15 mg/kg IV every 3 weeks on Day 1 |
| Carboplatin | DRUG | Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles |
| Paclitaxel | DRUG | Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
| Avastin | DRUG | Single-Dose 1mg/kg body weight by 90 minute intravenous infusion |
Inclusion Criteria: * Aged ≥ 18 years * ECOG performance status of 0-1 * Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer * At least one measurable lesion according to RECIST v1.1. * Able to receive bevacizumab, carboplatin and paclitaxel based on adequate la...
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