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Tazemetostat

Phase 2

Relapsed/Refractory Follicular Lymphoma With EZH2 | Small molecule | Oncology |HUTCHMED (China) Limited|Trials Updated: Jan 22, 2025

Tazemetostat development status

Highest phase Phase 2
Registered trials 8 across 7 sponsors since Aug 2014

Tazemetostat target and mechanism

Molecular targetEZH2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment103

FDA Designations

PRIORITY_REVIEWACCELERATED_APPROVAL

Tazemetostat clinical trials

Tazemetostat · 2 trials · 2 indications

Phase 2 2
NCT05713110A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory LymphomaRelapsed/Refractory Lymphoma
COMPLETED61 Analytics
NCT05467943Tazemetostat for the Treatment of Relapsed/Refractory Follicular LymphomaRelapsed/Refractory Follicular Lymphoma With EZH2
COMPLETED42 Analytics
PHASE2COMPLETED
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
Relapsed/Refractory LymphomaUnlock trial analytics
PHASE2COMPLETED
Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma
Relapsed/Refractory Follicular Lymphoma With EZH2Unlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
tazemetostatDRUGDose Escalation Phase (Phase IIa): Tazemetostat (800 mg BID orally) in a therapeutic cycle of 28 days; Dose Expansion Phase (Phase IIb): Tazemetostat (800 mg BID orally) in a therapeutic cycle of 28 days
HMPL-689DRUGDose Escalation Phase (Phase IIa): HMPL-689:20 mg and 30 mg, QD orally in a therapeutic cycle of 28 days. Dose Expansion Phase (Phase IIb): HMPL-689 (RP2D) in a therapeutic cycle of 28 days
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Frequently asked questions about Tazemetostat

What is tazemetostat used for?

Tazemetostat is being studied for relapsed or refractory follicular lymphoma with EZH2 alterations and for relapsed or refractory lymphoma. It is an investigational small molecule developed by HUTCHMED (China) Limited for these oncology indications and is not yet approved for them.

What does tazemetostat target?

Tazemetostat targets EZH2, an enzyme in the histone methyltransferase family. It acts as an EZH2 inhibitor, meaning it blocks the activity of this target. This mechanism is the basis for its investigation in lymphomas where EZH2 is implicated.

Who makes tazemetostat?

Tazemetostat is developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is running clinical development of the drug in lymphoma indications, including relapsed or refractory follicular lymphoma with EZH2 alterations and relapsed or refractory lymphoma.

What phase is tazemetostat in?

Tazemetostat is in Phase 2 clinical development. It has received FDA designations of Priority Review and Accelerated Approval. It remains an investigational agent and is not approved for the indications described here.

What clinical trials is tazemetostat in?

Tazemetostat has been studied in two completed Phase 2 trials. NCT05713110 evaluated tazemetostat in combination with HMPL-689 in patients with relapsed or refractory lymphoma, enrolling 61 patients. NCT05467943 evaluated tazemetostat in relapsed or refractory follicular lymphoma with EZH2 alterations, enrolling 42 patients.

Is tazemetostat approved by the FDA?

Tazemetostat is an investigational drug in Phase 2 development for the lymphoma indications described here. It has received FDA Priority Review and Accelerated Approval designations, but the available information does not indicate approval for these specific relapsed or refractory lymphoma uses.