CLINICAL TRIALS PROFILE FOR TAZVERIK

All Clinical Trials for TAZVERIK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04537715 ↗	A Two-part Study to Characterize Drug-Drug Interaction Effects on Steady-State Pharmacokinetics of Oral Tazemetostat	Recruiting	Epizyme, Inc.	Phase 1	2020-04-23	This is a phase I, multi-center, open-label, multi-dose, two-part PK and safety study to characterize the DDI potential of oral Tazemetostat.
NCT04557956 ↗	Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2021-02-01	This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF gene (BRAFV600) and that has spread to other places in the body (metastatic). Tazemetostat, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tazemetostat in combination with dabrafenib and trametinib may stabilize BRAFV600 mutated melanoma.
NCT04624113 ↗	Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma	Recruiting	Epizyme, Inc.	Phase 1/Phase 2	2021-04-14	The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.
NCT04624113 ↗	Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma	Recruiting	Washington University School of Medicine	Phase 1/Phase 2	2021-04-14	The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.
NCT04846478 ↗	Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC	Recruiting	Epizyme, Inc.	Phase 1	2021-06-28	This trial is testing whether molecularly targeted oral medications called talazoparib and tazemetostat can be safely combined for the treatment of prostate cancer, and whether the combination is effective in shrinking or preventing the growth of metastatic prostate cancer. The names of the study drugs involved in this study are: - Talazoparib - Tazemetostat
NCT04846478 ↗	Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC	Recruiting	Pfizer	Phase 1	2021-06-28	This trial is testing whether molecularly targeted oral medications called talazoparib and tazemetostat can be safely combined for the treatment of prostate cancer, and whether the combination is effective in shrinking or preventing the growth of metastatic prostate cancer. The names of the study drugs involved in this study are: - Talazoparib - Tazemetostat

Clinical Trial Conditions for TAZVERIK

Condition Name

Condition Name for TAZVERIK
Intervention	Trials
Follicular Lymphoma	4
Diffuse Large B Cell Lymphoma	2
Solid Tumor	2
Hematologic Malignancy	1

Condition MeSH

Condition MeSH for TAZVERIK
Intervention	Trials
Lymphoma	6
Neoplasms	4
Lymphoma, Large B-Cell, Diffuse	3
Lymphoma, Follicular	3

Clinical Trial Locations for TAZVERIK

Trials by Country

Trials by Country for TAZVERIK
Location	Trials
United States	19

Trials by US State

Trials by US State for TAZVERIK
Location	Trials
New York	3
Massachusetts	3
Missouri	2
California	2
South Carolina	1

Clinical Trial Progress for TAZVERIK

Clinical Trial Phase

Clinical Trial Phase for TAZVERIK
Clinical Trial Phase	Trials
Phase 2	4
Phase 1/Phase 2	5
Phase 1	5

Clinical Trial Status

Clinical Trial Status for TAZVERIK
Clinical Trial Phase	Trials
Not yet recruiting	8
Recruiting	7

Clinical Trial Sponsors for TAZVERIK

Sponsor Name

Sponsor Name for TAZVERIK
Sponsor	Trials
Epizyme, Inc.	11
Weill Medical College of Cornell University	3
Genentech, Inc.	2

Sponsor Type

Sponsor Type for TAZVERIK
Sponsor	Trials
Industry	16
Other	15
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Tazverik

Last updated: October 30, 2025

Introduction

Tazverik (tazemetostat) is an orally administered EZH2 (Enhancer of Zeste Homolog 2) inhibitor developed by Epizyme, Inc. Approved by the U.S. Food and Drug Administration (FDA) in January 2020, Tazverik is indicated for adult patients with epithelioid sarcoma not amenable to surgery or radiation therapy and for relapsed or refractory follicular lymphoma with specific EZH2 mutations. As a targeted therapy within the burgeoning epigenetics drug class, Tazverik's clinical development, market positioning, and future growth prospects warrant detailed analysis.

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Clinical Trials Update

Phase of Development and Ongoing Trials

Since its FDA approval, Tazverik has shifted focus from late-stage trials to post-market surveillance, real-world evidence collection, and expanding its indications. The main clinical trials and studies include:

• EPZ-0118 (NCT04591296): An ongoing Phase 2 study focusing on Tazverik's efficacy in synovial sarcoma, an orphan soft-tissue cancer. Synovial sarcoma's genetic complexity and previous unmet need make this a promising expansion area.
• NCT04405577: A study assessing long-term safety and quality-of-life outcomes for patients on Tazverik in epithelioid sarcoma.
• Combination Trials: Epizyme explores Tazverik alongside immune checkpoint inhibitors (e.g., nivolumab) to gauge synergistic effects, especially in "cold" tumors like sarcomas.
• Expansion in Follicular Lymphoma: Several trials (e.g., NCT04224463) are assessing Tazverik in combination with other therapies for relapsed follicular lymphoma, especially in patients with EZH2 mutations.

Results and Data Highlights

• Efficacy in Epithelioid Sarcoma: The pivotal phase 2 study demonstrated a 15% overall response rate (ORR) with durable disease control in 39% of patients, leading to FDA approval. Notably, patients with loss of the SMARCB1 gene exhibited higher response rates.
• Follicular Lymphoma: In the initial trials, Tazverik showed promising ORRs (about 69%) in EZH2-mutated follicular lymphoma, with manageable safety profiles.
• Safety Profile: Common adverse effects include fatigue, nausea, decreased appetite, and thrombocytopenia. Serious adverse events remain rare, supporting a favorable safety profile [1].

Regulatory and Label Expansion Efforts

• Approved Indications: The initial FDA approval targets epithelioid sarcoma and EZH2-mutant follicular lymphoma.
• Global Developments: Regulatory submissions are underway in Europe, with ongoing discussions with the European Medicines Agency (EMA). The firm is also exploring approvals in Asia-Pacific markets, particularly Japan and China.

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Market Analysis

Current Market Landscape

The epigenetics drugs market is projected to reach approximately USD 8.7 billion by 2025, exhibiting CAGR of 20% [2]. Tazverik occupies a niche within this space, targeting rare cancers with unmet needs and genetic driver mutations.

• Epithelioid Sarcoma Market: A rare sarcoma with an annual incidence of approximately 1 per million in the U.S., estimated at 100-150 new cases annually. No approved targeted therapies previously existed, positioning Tazverik as an innovative treatment.
• Follicular Lymphoma: The second most common non-Hodgkin lymphoma, with a global market size exceeding USD 4 billion. EZH2 mutations are present in roughly 20-25% of cases, allowing targeted use of Tazverik.

Competitive Landscape

• EZH2 Inhibitors: Tazverik is among the first approved EZH2 inhibitors. Key competitors include GSK's tazemetostat (similar molecule), which is also undergoing expansion trials.
• Alternative Therapies: For epithelioid sarcoma, treatments remain largely supportive. For follicular lymphoma, options include PI3K inhibitors, monoclonal antibodies (e.g., rituximab), and CAR-T therapies. Tazverik’s oral administration offers convenience and potential compliance advantages.

Market Drivers and Barriers

• Drivers: Rising adoption of precision medicine, increased genetic testing for EZH2 mutations, expanding indications, and a supportive safety profile promote market growth.
• Barriers: The rarity of EPZ-0118 this niche limits large-scale sales; reimbursement hurdles and high drug costs may impede broader adoption.

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Market Projection and Future Outlook

Forecasting Growth

Based on current data, the Tazverik market is projected to grow at a CAGR of roughly 15-18% over the next five years, driven by:

• Expansion into additional tumor types (e.g., synovial sarcoma, breast cancer).
• New combination therapy trials (e.g., with immunotherapy agents).
• Increasing global approval and adoption, notably if approved in Europe and Asia.

Potential Revenue

• 2023-2025: Estimated revenue of USD 250-350 million, increasing as indications expand.
• Long-term: With potential approvals for additional indications, including solid tumors and hematological malignancies, global sales could reach USD 1 billion annually by 2030.

Pipeline and Innovation

Ongoing research aims to optimize dosing, improve response rates, and explore combination regimens that may significantly elevate clinical success. The company's strategic partnership with academic institutions and investment in personalized medicine signals a robust growth trajectory.

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Key Takeaways

• Tazverik has established a niche in the treatment of epithelioid sarcoma and EZH2-mutant follicular lymphoma, with promising ongoing trials for broader indications.
• The drug benefits from a favorable safety profile and oral administration, key factors for patient compliance and market penetration.
• Market expansion hinges on successful demonstration of efficacy in additional tumor types, regulatory approvals across key regions, and accelerated adoption of companion diagnostics.
• Competitive positioning is strengthened by the company’s focus on rare cancers and targeted therapies, but commercialization challenges remain due to the rarity of some indications.
• Future growth is projected to be steady, with a potential to surpass USD 1 billion in annual sales if expanded indications and combination therapies prove successful.

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FAQs

1. What are the main indications for Tazverik currently?
Tazverik is approved for epithelioid sarcoma and EZH2 mutation-positive follicular lymphoma.

2. Are there ongoing trials for Tazverik in other cancers?
Yes, ongoing trials are evaluating Tazverik in synovial sarcoma, diffuse large B-cell lymphoma, and in combination with immunotherapies across various solid tumors.

3. How does Tazverik compare to competing EZH2 inhibitors?
Tazverik distinguishes itself through its oral formulation, favorable safety profile, and recent approval in orphan and hematologic cancers, with ongoing efforts to expand its clinical uses.

4. What challenges does Tazverik face in market expansion?
Limited patient populations due to the rarity of certain cancers, high treatment costs, and reimbursement complexities pose significant hurdles.

5. What is the potential for Tazverik in future oncology treatments?
With ongoing exploration of combination therapies and new indications, Tazverik has substantial growth potential, especially within personalized and precision medicine paradigms.

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References

[1] Epizyme's FDA approval announcement, 2020.
[2] MarketWatch, Epigenetics Drugs Market Analysis, 2022.