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.

Tumor Type
Treatment Approach
Phase 1
Phase 2
Phase 3

TAZVERIK® (tazemetostat)

Epithelioid Sarcoma
Monotherapy
Approved January 2020

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

Follicular Lymphoma
Monotherapy
Approved June 2020

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.

Follicular Lymphoma
Combination w/ R2

Phase 3

Study details:

EZH-302: Phase 1b/3 Confirmatory trial in 2nd line FL

Learn more at ClinicalTrials.gov Open

R2 = Revlimid® (lenalidomide, Bristol Myers Squibb) + a rituximab product

Follicular Lymphoma
Combination w/ rituximab

Phase 2

Study details:

EZH-1401: Phase 2 trial in 3rd line+ FL

Learn more at ClinicalTrials.gov Open

Follicular Lymphoma
Combination w/ R-CHOP

Phase 2

Study details:

Lysa Phase 2 High-risk front-line FL

Learn more at ClinicalTrials.gov Open

Epithelioid Sarcoma
Combination w/ doxorubicin

Phase 3

Study details:

EZH-301: Phase 1b/3 Confirmatory trial in front-line ES

Learn more at ClinicalTrials.gov Open

Prostate Cancer
Enzalutamide or Abiraterone/Prednisone (Abi/Enza)

Phase 2

Study details:

EZH-1101: Phase 1b/2 R/R Prostate Cancer

Learn more at ClinicalTrials.gov Open

SETD2 – EZM0414

Multiple Myeloma & DLBCL
Monotherapy

Phase 1

SET-101: Phase 1/1b safety, dose finding, and expansion study in relapsed/refractory multiple myeloma and DLBCL

PROTEIN ARGININE METHYLTRANSFERASES (PRMTs)

PRMT 5 Inhibitor (GSK3326595)

Phase 2

Study details:

GSK Solid tumors and blood cancers

GlaxoSmithKline holds global development and commercialization rights.

PRMT 1 Inhibitor (GSK3368715)

Phase 1

Study details:

GSK Solid tumors and blood cancers

GlaxoSmithKline holds global development and commercialization rights.

TAZVERIK® (tazemetostat)

Epithelioid Sarcoma
Monotherapy
Approved January 2020

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

Follicular Lymphoma
Monotherapy
Approved June 2020

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

Follicular Lymphoma
Combination w/ R2

Phase 3

Study details:

EZH-302: Phase 1b/3 Confirmatory trial in 2nd line FL

Learn more at ClinicalTrials.gov Open

R2 = Revlimid® (lenalidomide, Bristol Myers Squibb) + a rituximab product

Follicular Lymphoma
Combination w/ rituximab

Phase 2

Study details:

EZH-1401: Phase 2 trial in 3rd line+ FL

Learn more at ClinicalTrials.gov Open

Follicular Lymphoma
Combination w/ R-CHOP

Phase 2

Study details:

Lysa Phase 2 High-risk front-line FL

Learn more at ClinicalTrials.gov Open

Epithelioid Sarcoma
Combination w/ doxorubicin

Phase 3

Study details:

EZH-301: Phase 1b/3 Confirmatory trial in front-line ES

Learn more at ClinicalTrials.gov Open

Prostate Cancer
Enzalutamide or Abiraterone/Prednisone (Abi/Enza)

Phase 2

Study details:

EZH-1101: Phase 1b/2 R/R Prostate Cancer

Learn more at ClinicalTrials.gov Open

SETD2 – EZM0414

Multiple Myeloma & DLBCL
Monotherapy

Phase 1

SET-101: Phase 1/1b safety, dose finding, and expansion study in relapsed/refractory multiple myeloma and DLBCL

PROTEIN ARGININE METHYLTRANSFERASES (PRMTs)

PRMT 5 Inhibitor (GSK3326595)

Phase 2

Study details:

GSK Solid tumors and blood cancers

GlaxoSmithKline holds global development and commercialization rights.

PRMT 1 Inhibitor (GSK3368715)

Phase 1

Study details:

GSK Solid tumors and blood cancers

GlaxoSmithKline holds global development and commercialization rights.

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).