What clinical trial stage is Tazemetostat currently in?

Tazemetostat is an oral EZH2 inhibitor, mainly used to treat hematological malignancies such as relapsed or refractory follicular lymphoma (FL). At present, the clinical research and approval progress of this drug in China is as follows:

First, tazerestat has completed a multicenter, open-label Phase II bridging study (NCT05467943) in China to evaluate Its efficacy and safety in EZH2mutation-positive relapsed/refractory FL patients. A total of 42 patients were included in the study. The primary endpoint was objective response rate (ORR), and secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS), as well as safety and pharmacokinetics and other indicators.

Based on the positive results of the above-mentioned bridging study, and Epizyme’s clinical trial data conducted outside China, China’s National Medical Products Administration (NMPA) has announced in 2025Tazerestat was granted conditional approval in March for the treatment of adult patients with relapsed EZH2 mutation-positive / refractory FL after receiving at least two prior systemic therapies.

In order to further confirm the clinical benefit of tazerestat, an international multi-center, randomized, double-blind, active-controlled phase III clinical trial called SYMPHONY-1 is currently underway. The study was designed to evaluate the efficacy and safety of tazerestat combined with rituximab and lenalidomide in the treatment of patients with relapsed/refractory FL.

In addition, Chi-Med plans to conduct clinical studies in China for other indications such as solid tumors (such as ovarian cancer, breast cancer and prostate cancer) to expand the treatment scope of tazetostat.

In summary, tazerestat has completed the Phase II bridging study in China and received conditional approval from the NMPA. Currently, phase III confirmatory clinical trials are underway, and more indications are planned to be studied in the future to further verify its efficacy and safety.

Reference materials:https://www.tazverik.com/