Shots:
- Shanghai Henlius has dosed the first US patient in the global P-I trial of HLX17, a biosimilar version of Keytruda (pembrolizumab), for the adjuvant treatment of multiple resected solid tumors
- P-I multicentre study evaluates the PK, efficacy, safety, and immunogenicity of HLX17 vs Keytruda in pts with resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma. Participants are randomized 1:1 to receive either HLX17 (200 mg Q3W for up to 12 months) or Keytruda (200 mg Q3W for 8 cycles, followed by HLX17 Q3W until 12 months).
- The 1EP is to demonstrate PK similarity, assessed by AUC0–21d after the first dose and AUCss after the sixth dose. 2EPs include additional PK measures, efficacy, safety, and immunogenicity
Ref: Henlius | Image: Henlius | Press Release
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