Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a biosimilar bevacizumab and an anti–programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors.
Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a proposed biosimilar bevacizumab and an anti—programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors. The study is expected to start at the end of September 2019.
Henlius is developing the novel monoclonal antibody HLX10, which binds to and inhibits PD-1 and its downstream signaling pathways, potentially restoring immune function through activation of T cells and T-cell mediated immune responses against tumor cells. The phase 1 study will evaluate this antibody in combination with HLX04, a proposed bevacizumab biosimilar referencing Avastin.
The interventional trial will enroll an estimated 30 patients with solid tumors. They will be given HLX10 at 3 dose levels once every 2 weeks, and the biosimilar bevacizumab at a fixed dose of 5 mg/kg once every 2 weeks. The study drugs will be given in combination for up to 2 years or until disease progression.
The proposed biosimilar bevacizumab has already been the subject of a pharmacokinetic, safety, and immunogenicity study in comparison with reference Avastin products licensed in China, the United States, and the European Union, in 208 healthy volunteers.1 The study demonstrated the 4-way PK equivalence among the biosimilar and all 3 reference products, as the 90% confidence intervals for the test-to-reference ratios of PK parameters fell within the prespecified equivalence margin of 80% to 125%.
A phase 3 confirmatory trial has also been initiated to compare the efficacy, safety, and immunogenicity of the biosimilar to its reference, together with oxaliplatin and fluorouracil-based chemotherapy, as a first-line treatment for metastatic colorectal cancer. The phase 3 study is expected to be completed in 2020.
Henlius is also the developer of HLX01, the first biosimilar to be approved in China. The rituximab product, referencing MabThera/Rituxan, earned regulatory authorization in February 2019.
1. Ding Y, Yu T, Sun J, et al. A China-manufactured bevacizumab biosimilar, HLX04, matches bevacizumab sourced from China, USA and the European Union. Ann Oncol. 2018;29(9). doi: 10.1093/annonc/mdy431.019.