Hutchmed has dosed the first participant in a bridging study of tazemetostat to treat relapsed/refractory follicular lymphoma (R/R FL) in China.
The open-label, multicentre Phase II bridging study is designed to evaluate tazemetostat’s safety, pharmacokinetics, and efficacy to treat R/R FL patients.
The evaluation of tazemetostat’s efficacy in R/R FL patients who have mutations in EZH2 (Cohort 1) will be the study’s primary objective.
Some of the trial’s secondary objectives include assessing the therapy’s safety and the pharmacokinetics to treat R/R FL patients and efficacy to treat R/R FL patients who have EZH2 wild type (Cohort 2).
Dr Junning Cao of Shanghai Fudan University Cancer Center is the lead principal investigator of the study.
Developed by biotech company Epizyme, tazemetostat is a methyltransferase inhibitor of EZH2, which catalyses the methylation of histone H3 that controls the expression of various genes.
In August last year, Hutchmed and Epizyme entered a strategic collaboration for the research, development, production and marketing of tazemetostat in China, Hong Kong, Macau and Taiwan.
Tazemetostat received the US Food and Drug Administration (FDA) approval to treat certain patients with advanced epithelioid sarcoma (ES) in January 2020 and certain R/R FL patients in June 2020.
Under the Clinically Urgently Needed Imported Drugs scheme, the Health Commission and Medical Products Administration of Hainan Province of China approved tazemetostat in May 2022 for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone) to treat certain ES and FL patients consistent with the label as approved by the FDA.
Recently, Hutchmed dosed the first subject in the Phase I clinical trial of HMPL-A83 to treat advanced malignant neoplasm patients in China.