HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a bridging study for Tazverik (tazemetostat) in China, with the first patient dosed on July 29, 2022. The multi-center, open-label, Phase II study (NCT05467943) will evaluate the drug’s efficacy, safety, and pharmacokinetics in relapsed/refractory follicular lymphoma (FL).
Drug Background
Tazverik, an EZH2 methyltransferase inhibitor developed by Epizyme, Inc., received accelerated approval in the U.S. for advanced epithelioid sarcoma (January 2020) and certain relapsed/refractory follicular lymphomas (June 2020). HutchMed licensed the drug in August 2021 for research, development, manufacturing, and commercialization in Greater China.
China Study Details
The study aims to support Tazverik’s registration in China. The drug was granted special entry via the Hainan Free Trade Port’s Boao Lecheng International Medical Tourism Pilot Zone in May 2023 for treating epithelioid sarcomas and follicular lymphomas.
Collaboration and Global Development
HutchMed and Epizyme are jointly developing Tazverik in Greater China for multiple blood cancers and solid tumors. HutchMed leads the Chinese arm of the SYMPHONY-1 study and will collaborate on other global trials.-Fineline Info & Tech
