1080PA new population model validated pharmacokinetic similarity of HLX01 and rituximab in B-cell lymphoma

ConclusionsThis PopPK model derived from RA patients can predict HLX01 and CN-RTX in patients DLBCL. HLX01 and EU-/CN-RTX had similar PK parameters and influential PK covariates. These results provided further evidence for PK similarity between HLX01 and RTXs in patients with RA or DLBCL.Clinical trial identificationTwo trials were listed in this abstract: 1. A Randomised, Double-blind, Phase 1/2 Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs ClinicalTrials.gov Identifier: NCT03355872 2. Clinical Phase 3 Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL ClinicalTrials.gov Identifier: NCT02787239.Legal entity responsible for the studyShanghai Henlius Biotech, Inc.FundingShanghai Henlius Biotech,Inc.DisclosureY. Shi: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Y. Dan: Full / Part-time employment: Shanghai Henlius Biotech,Inc. Y. Hong: Shareholder / Stockholder / Stock options, Full / Part-time employment: Shanghai Henlius Biotech, Inc. J. Guo: Full / Part-time employment: Shanghai Henlius Biotech, Inc. S. Zhao...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research