HENLIUS (ASX: 02696) has announced that the first patient in the United States has been dosed in its international multi-center Phase 1 clinical study for HLX17, the company's self-developed biosimilar of pembrolizumab. This trial is being conducted in patients with various resected solid tumors.
The Phase 1 study is also being carried out concurrently within mainland China. This research is a multi-center, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic profile, efficacy, safety, and immunogenicity of HLX17 compared to the US-marketed KEYTRUDA® in subjects with resected solid tumors, including non-small cell lung cancer, melanoma, or renal cell carcinoma.
Eligible subjects will be randomly assigned in a 1:1 ratio to either Group A or Group B. Subjects in Group A will receive intravenous HLX17 at 200mg every three weeks starting from Cycle 1, continuing for up to 12 months post-randomization (approximately 17 cycles) or until disease recurrence, death, initiation of new anti-tumor therapy, intolerable toxicity, withdrawal of consent, or study termination occurs. Subjects in Group B will receive US-marketed KEYTRUDA® at 200mg every three weeks for the first 8 cycles (24 weeks), then switch to receiving HLX17 at 200mg every three weeks, continuing until 12 months post-randomization or meeting discontinuation criteria.
The primary objective of this study is to assess the pharmacokinetic similarity between HLX17 and US-marketed KEYTRUDA® following single and multiple intravenous infusions. The main endpoints include the area under the serum concentration-time curve from 0 to 21 days after the first dose and the area under the curve within a single dosing interval at steady state after the sixth dose. Secondary endpoints encompass other pharmacokinetic parameters, efficacy, safety, and immunogenicity.
HLX17 is a self-developed biosimilar of pembrolizumab by the company. Its potential indications cover the range already approved for the originator drug, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, and tumors that are microsatellite instability-high or mismatch repair deficient.
The PD-1 receptor expressed on T cells binds to its ligands PD-L1 and PD-L2, which can inhibit T cell proliferation and cytokine production. Some tumor cells upregulate PD-1 ligands, and signaling through this pathway can suppress the immune surveillance of tumors by activated T cells. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2. This action releases the immune suppression mediated by the PD-1 pathway, including anti-tumor immune responses, thereby enhancing the immune system's ability to attack tumor cells.
In September 2024, the clinical trial application for HLX17 was approved by China's National Medical Products Administration. In September 2025, the Investigational New Drug application for the Phase 1 trial of HLX17 in patients with resected solid tumors received approval from the US Food and Drug Administration. Also in September 2025, the first patient in mainland China was dosed in this international multi-center Phase 1 study for HLX17.
According to data from IQVIA MIDASTM, a global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, the global sales for pembrolizumab in 2025 were approximately $35.423 billion.
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