China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021.
Tazverik’s Background and Previous Approvals
The molecule, an EZH2 methyltransferase inhibitor, has already secured fast-tracked approvals in the United States for the treatment of advanced epithelioid sarcoma and certain relapsed/refractory follicular lymphomas in January and June of 2020, respectively. These approvals highlight the drug’s potential impact on patients with these conditions.
Design and Objectives of HutchMed’s Bridging Study
HutchMed’s bridging study is a multi-center, open-label, Phase II trial (NCT05467943) designed to assess the efficacy, safety, and pharmacokinetics of Tazverik in relapsed/refractory follicular lymphoma (FL). The primary objective is to evaluate the objective response rate (ORR) of tazemetostat in recurrent/refractory follicular lymphoma patients with EZH2 mutations (cohort 1). Secondary goals include evaluating the duration of remission (DoR), progression-free survival (PFS), and overall survival (OS) of tazemetostat in recurrent/refractory follicular lymphoma patients with or without EZH2 mutations (cohort 2), as well as assessing safety and pharmacokinetics. A total of 42 patients have been enrolled in this study, marking a significant step towards expanding access to this treatment in China.-Fineline Info & Tech
