A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

Summary

In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.

Timeline

Start

2019-11-15

Primary completion

2024-07-01

Completion

2025-12

Outcome

Met primary endpoint

release “NSCLC), evaluating the efficacy and safety of HD204 against the reference product. For the primary endpoint — objective response rate (ORR) at 18 weeks — HD204 achieved” prestigebiopharma.com ↗

release “For the primary endpoint — objective response rate (ORR) at 18 weeks — HD204 achieved 48.7% versus 46.5% for reference Avastin, meeting pre-specified equivalence criteria” prestigebiopharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	HD204	Unknown	15 mg/kg	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous

Indications