On August 1, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it has initiated a bridging study of tazemetostat in China. The first patient received their first dose on July 29, 2022 (Press release, Hutchison China MediTech, AUG 1, 2022, View Source [SID1234617169]).
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The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma ("R/R FL"). The primary objective is to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have mutations in EZH2[1] (Cohort 1). The secondary objectives are to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have EZH2 wild-type (Cohort 2) and to evaluate the safety and the pharmacokinetics of tazemetostat for treatment of patients with R/R FL. The lead principal investigator is Dr Junning Cao of Shanghai Fudan University Cancer Center. Additional details may be found at clinicaltrials.gov, using identifier NCT05467943.
Tazemetostat is a methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. ("Epizyme"). It is approved by the U.S. Food and Drug Administration ("FDA") for the treatment of certain patients with advanced epithelioid sarcoma ("ES") and certain patients with R/R FL under the FDA accelerated approval granted in January and June 2020, respectively.
In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.
In May 2022, tazemetostat was approved by the Health Commission and Medical Products Administration of Hainan Province of China to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone ("Hainan Pilot Zone"), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA.
About FL and ES
FL is a subtype of non-Hodgkin’s lymphoma ("NHL"). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. [2],[3],[4]
ES is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.[5]
About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated in the United States for the treatment of:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
View the U.S. Full Prescribing Information here: www.tazverik.com
TAZVERIK is a registered trademark of Epizyme, Inc.
About Tazemetostat Clinical Development in China
HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly.
SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R2 in patients with relapsed or refractory FL after at least one prior line of therapy (clinicaltrials.gov identifier: NCT04224493).
We intend to initiate several combination studies of tazemetostat with HUTCHMED assets.