Clinical Trials
At Epizyme, we have a comprehensive and innovative clinical development plan for tazemetostat, which we believe will have a steady stream of data over the course of the next several years. Our aim is to characterize the potential benefit of tazemetostat to patients in early lines of treatment for epithelioid sarcoma (ES) and follicular lymphoma (FL) by exploring various combination with standard of care therapies. We also plan to explore tazemetostat as both monotherapy and in combination in potential new indications. Indication or study details on each program are available by clicking the plus sign below.
TAZVERIK® (tazemetostat)
Indication:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
These indications are approved under accelerated approval 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. See full U.S. prescribing information at www.TAZVERIK.com
Indication:
Adult patients with relapsed or refractory follicular lymphoma (FL) 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 FL who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval 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. See full U.S. prescribing information at www.TAZVERIK.com
TAZEMETOSTAT
Eisai holds rights to tazemetostat in Japan.
Phase 3
Study details:
EZH-302: Phase 1b/3 Confirmatory trial in 2nd line FL
Learn more at ClinicalTrials.gov 
R2 = Revlimid® (lenalidomide, Bristol Myers Squibb) + a rituximab product
Phase 2
Phase 2 High-risk front-line FLPhase 3
Study details:
EZH-301: Phase 1b/3 Confirmatory trial in front-line ES
Phase 2
Phase 2
Study details:
EZH-1501: Phase 1b/2 R/R Hematologic Malignancies
- Tazmetostat plus CD19 Ab (tafasitamab-cxix)/ lenalidomide in subjects with R/R DLBCL*
- Tazemetostat plus lenalidomide in subjects with R/R DLBCL*
- Tazemetostat plus bi-specific antibody in subjects with R/R follicular lymphoma^
- Tazemetostat plus Bruton tyrosine kinase inhibitor (acalabrutinib) in subjects with R/R mantle cell lymphoma
- Tazemetostat plus Daratumumab/ pomalidomide/ dexamethasone in subjects with R/R multiple myeloma
Learn more at ClinicalTrials.gov
*open for enrollment
^planned enrollment in March 2022
SETD2 – EZM0414
Phase 1
SET-101: Phase 1/1b safety, dose finding, and expansion study in relapsed/refractory multiple myeloma and DLBCL
TAZVERIK® (tazemetostat)
Indication:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
These indications are approved under accelerated approval 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. See full U.S. prescribing information at www.TAZVERIK.com
Indication:
Adult patients with relapsed or refractory follicular lymphoma (FL) 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 FL who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval 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. See full U.S. prescribing information at www.TAZVERIK.com
TAZEMETOSTAT
Phase 3
Study details:
EZH-302: Phase 1b/3 Confirmatory trial in 2nd line FL
Learn more at ClinicalTrials.gov
R2 = Revlimid® (lenalidomide, Bristol Myers Squibb) + a rituximab product
Phase 2
Phase 3
Study details:
EZH-301: Phase 1b/3 Confirmatory trial in front-line ES
Phase 2
Phase 2
Study details:
EZH-1501: Phase 1b/2 R/R Hematologic Malignancies
- Tazmetostat plus CD19 Ab (tafasitamab-cxix)/ lenalidomide in subjects with R/R DLBCL*
- Tazemetostat plus lenalidomide in subjects with R/R DLBCL*
- Tazemetostat plus bi-specific antibody in subjects with R/R follicular lymphoma^
- Tazemetostat plus Bruton tyrosine kinase inhibitor (acalabrutinib) in subjects with R/R mantle cell lymphoma
- Tazemetostat plus Daratumumab/ pomalidomide/ dexamethasone in subjects with R/R multiple myeloma
Learn more at ClinicalTrials.gov
*open for enrollment
^planned enrollment in March 2022
SETD2 – EZM0414
Phase 1
SET-101: Phase 1/1b safety, dose finding, and expansion study in relapsed/refractory multiple myeloma and DLBCL
For additional information regarding access to Epizyme’s clinical trials, please visit www.clinicaltrials.gov or click the link within the individual trial. You can also email us at clinicaltrials@epizyme.com or call us at 855-500-1011 (U.S. toll-free).