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...
Top 20 of 77 competitors
HD204 is an investigational small molecule being studied for use in advanced non-squamous non-small cell lung cancer and in healthy volunteers. It is a proposed biosimilar to bevacizumab (Avastin), and clinical trials are evaluating its pharmacokinetic equivalence and its efficacy, safety, pharmacokinetics and immunogenicity compared to the reference product.
HD204 is a proposed biosimilar to bevacizumab (Avastin), which targets vascular endothelial growth factor (VEGF). By binding to VEGF, it is intended to inhibit angiogenesis, the formation of new blood vessels that tumors need to grow. This mechanism is being evaluated in clinical trials for advanced non-squamous non-small cell lung cancer.
HD204 is being developed by Prestige Consumer Healthcare Inc., a company traded on the New York Stock Exchange under the ticker symbol PBH. The company is conducting clinical trials to evaluate the drug's pharmacokinetic equivalence and its efficacy and safety compared to bevacizumab (Avastin) in patients with advanced non-squamous non-small cell lung cancer.
HD204 is in Phase 1 and Phase 3 clinical development. A Phase 1 trial in healthy male subjects has been completed, and a Phase 3 trial in patients with advanced non-squamous non-small cell lung cancer is active but not recruiting. The drug is investigational and has not been approved by regulatory authorities.
HD204 is being studied in two clinical trials. NCT03390673 is a completed Phase 1 trial in healthy male subjects in New Zealand, evaluating pharmacokinetic equivalence to bevacizumab. NCT03390686 is an active Phase 3 trial in patients with advanced non-squamous non-small cell lung cancer across multiple countries, comparing efficacy, safety, pharmacokinetics and immunogenicity to Avastin.
HD204 is a proposed biosimilar to bevacizumab (Avastin), meaning it is designed to be highly similar to the reference biologic. Clinical trials are comparing HD204 to Avastin to demonstrate equivalent pharmacokinetic properties and comparable efficacy, safety and immunogenicity. It is not yet approved and is still under investigation.