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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HD204 is an investigational small molecule being studied for use in lung cancer, specifically advanced non-squamous non-small cell lung cancer, and has also been evaluated in healthy volunteers. It is being developed by Prestige Consumer Healthcare Inc. (PBH) and is currently in Phase 1 clinical development.
HD204 targets VEGF-A, a protein involved in blood vessel growth. In clinical trials, it is being compared to Avastin (bevacizumab) for efficacy, safety, pharmacokinetics, and immunogenicity in patients with advanced non-squamous non-small cell lung cancer.
HD204 is being developed by Prestige Consumer Healthcare Inc., a company traded on the stock exchange under the ticker PBH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in lung cancer and healthy volunteer populations.
HD204 is currently in Phase 1 clinical development. While a Phase 3 trial has been conducted, the drug remains investigational and has not been approved by regulatory authorities. It is still undergoing clinical evaluation to determine its safety and effectiveness.
HD204 has been studied in two clinical trials. NCT03390686 is a Phase 3 trial comparing HD204 to Avastin in patients with advanced non-squamous non-small cell lung cancer, with 650 participants. NCT03390673 is a completed Phase 1 trial in healthy male subjects to assess pharmacokinetic equivalence with bevacizumab.
HD204 is not the same as Avastin, but it is being studied as a potential biosimilar to it. Clinical trials are comparing HD204 to Avastin (bevacizumab) to evaluate whether HD204 has equivalent efficacy, safety, pharmacokinetics, and immunogenicity in treating advanced non-squamous non-small cell lung cancer.