Therapy Detail
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| Therapy Name | Tazemetostat |
| Synonyms | |
| Therapy Description |
Tazverik (tazemetostat) binds to and inhibits EZH2, resulting in decreased tri-methylation of H3K27, which potentially leads to inhibition of cell proliferation and tumor growth (PMID: 23620515). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Tazemetostat | Tazverik | EPZ6438|E-7438|EPZ-6438 | EZH2 inhibitor 20 | Tazverik (tazemetostat) binds to and inhibits EZH2, resulting in decreased tri-methylation of H3K27, which potentially leads to inhibition of cell proliferation and tumor growth (PMID: 23620515). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| SMARCB1 loss | rhabdoid cancer | sensitive | Tazemetostat | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Tazemetostat (EPZ-6438) inhibited growth of SMARCB1-deficient malignant rhabdoid tumor cell lines in culture, and inhibited H3K27 trimethylation and induced tumor regression in a SMARCB1-deleted human malignant rhabdoid tumor cell line xenograft model (PMID: 23620515). | 23620515 |
| SMARCB1 negative | Advanced Solid Tumor | predicted - sensitive | Tazemetostat | Phase I | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) demonstrated safety and preliminary efficacy, resulted in clinical benefit (stable disease or better) in 38% (5/13) of patients with SMARCB1 or SMARCA4-negative advanced solid tumors (PMID: 29650362; NCT01897571). | 29650362 |
| SMARCB1 negative | epithelioid sarcoma | predicted - sensitive | Tazemetostat | Phase I | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) was well-tolerated and demonstrated anti-tumor activity in pediatric patients with SMARCB1 (INI)-deficient tumors, including complete or partial responses in patients with epithelioid sarcoma (n=1), chordoma (n=2), and atypical teratoid rhaboid tumor (n=1) (AACR-NCI-EORTC Int Conference on Molecular Targets and Cancer Therapeutics 2017, A175; NCT02601937). | detail... |
| SMARCB1 negative | epithelioid sarcoma | predicted - sensitive | Tazemetostat | Phase II | Actionable | In a Phase II trial, Tazverik (tazemetostat) treatment resulted in an objective response rate of 15% (9/62) and a disease control rate of 26% (16/62) in patients with locally advanced or metastatic SMARCB1 (INI1)-negative epithelioid sarcoma, with a median duration of response not reached and a median overall survival of 82.4 weeks (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 11003-11003, NCT02601950). | detail... |
| SMARCB1 negative | epithelioid sarcoma | predicted - sensitive | Tazemetostat | Case Reports/Case Series | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) demonstrated safety and preliminary efficacy, resulted durable stable disease in 2 patients with SMARCB1-negative epithelioid sarcoma (PMID: 29650362; NCT01897571). | 29650362 |
| SMARCB1 loss | nasal cavity carcinoma | predicted - sensitive | Tazemetostat | Case Reports/Case Series | Actionable | In a clinical study, Tazverik (tazemetostat) resulted in a clinical benefit in two patients with loss of SMARCB1, including one patient with sinonasal carcinoma and the other patient with sinonasal undifferentiated carcinoma, with stable disease lasting 13 and 8 months, respectively (PMID: 35820243). | 35820243 |
| SMARCB1 negative | chordoma | predicted - sensitive | Tazemetostat | Phase I | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) was well-tolerated and demonstrated anti-tumor activity in pediatric patients with SMARCB1 (INI)-deficient tumors, including complete or partial responses in patients with epithelioid sarcoma (n=1), chordoma (n=2), and atypical teratoid rhaboid tumor (n=1) (AACR-NCI-EORTC Int Conference on Molecular Targets and Cancer Therapeutics 2017, A175; NCT02601937). | detail... |
| SMARCB1 negative | atypical teratoid rhabdoid tumor | predicted - sensitive | Tazemetostat | Phase I | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) was well-tolerated and demonstrated anti-tumor activity in pediatric patients with SMARCB1 (INI)-deficient tumors, including complete or partial responses in patients with epithelioid sarcoma (n=1), chordoma (n=2), and atypical teratoid rhaboid tumor (n=1) (AACR-NCI-EORTC Int Conference on Molecular Targets and Cancer Therapeutics 2017, A175; NCT02601937). | detail... |
| SMARCA4 negative | Advanced Solid Tumor | predicted - sensitive | Tazemetostat | Phase I | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) demonstrated safety and preliminary efficacy, resulted in clinical benefit (stable disease or better) in 38% (5/13) of patients with SMARCB1 or SMARCA4-negative advanced solid tumors (PMID: 29650362; NCT01897571). | 29650362 |
| RB1 del SMARCB1 loss | rhabdoid cancer | resistant | Tazemetostat | Preclinical - Cell culture | Actionable | In a preclinical study, a SMARCB1-deficient rhabdoid cancer cell line with a deletion of RB1 was resistant to Tazverik (tazemetostat) in culture (PMID: 38315003). | 38315003 |
| SMARCB1 negative | rhabdoid cancer | predicted - sensitive | Tazemetostat | Case Reports/Case Series | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) demonstrated safety and preliminary efficacy, resulted in a durable complete response lasting over 2.3 years in a patient with SMARCB1-negative malignant rhabdoid tumor (PMID: 29650362; NCT01897571). | 29650362 |
| SMARCA4 negative | rhabdoid cancer | predicted - sensitive | Tazemetostat | Case Reports/Case Series | Actionable | In a Phase I trial, Tazemetostat (EPZ-6438) demonstrated safety and preliminary efficacy, resulted in 1 partial response and 1 durable stable disease in patient with SMARCA4-negative malignant rhabdoid tumor of the ovary (PMID: 29650362; NCT01897571). | 29650362 |
| RB1 I124Rfs*6 RB1 del SMARCB1 loss | epithelioid sarcoma | predicted - resistant | Tazemetostat | Case Reports/Case Series | Actionable | In a clinical case study, a patient with SMARCB1-deficient epithelioid sarcoma progressed on treatment with Tazverik (tazemetostat) and was found to have acquired a hemizygous deletion of RB1 and RB1 I124Rfs*6 (PMID: 38315003). | 38315003 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06575686 | Phase II | Tazemetostat Epcoritamab-bysp + Tazemetostat | Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma | Suspended | USA | 0 |
| NCT02875548 | Phase II | Tazemetostat | Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study | Terminated | USA | POL | GBR | FRA | BEL | AUS | 1 |
| NCT04557956 | Phase Ib/II | Tazemetostat Dabrafenib + Tazemetostat + Trametinib | 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 | Active, not recruiting | USA | 0 |
| NCT04241835 | Phase I | Tazemetostat | A Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies | Terminated | USA | SVK | POL | FRA | BEL | 0 |
| NCT02860286 | Phase II | Tazemetostat | Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma | Completed | USA | GBR | FRA | 0 |
| NCT02601937 | Phase I | Tazemetostat | A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma | Completed | USA | NLD | ITA | GBR | FRA | DNK | DEU | CAN | AUS | 0 |
| NCT02601950 | Phase II | Tazemetostat | A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma | Completed | USA | ITA | GBR | FRA | DEU | CAN | BEL | AUS | 1 |
| NCT05934838 | Phase I | Tazemetostat | A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas | Active, not recruiting | USA | 0 |
| NCT03217253 | Phase I | Tazemetostat | Tazemetostat in Treating Patients With Metastatic or Unresectable Solid Tumors or B-Cell Lymphomas With Liver Dysfunction | Withdrawn | USA | 0 |
| NCT04917042 | Phase II | Tazemetostat | Tazemetostat in Malignant Peripheral Nerve Sheath Tumors | Active, not recruiting | USA | 0 |
| NCT03348631 | Phase II | Tazemetostat | Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer | Active, not recruiting | USA | 0 |
| NCT03213665 | Phase II | Tazemetostat | Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) | Completed | USA | 1 |
| NCT03155620 | Phase II | Tazemetostat Larotrectinib Vemurafenib Ivosidenib Palbociclib Selumetinib Tipifarnib LY3023414 Selpercatinib Olaparib Ulixertinib Erdafitinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Active, not recruiting | USA | CAN | AUS | 1 |
| NCT05567679 | Phase I | Tazemetostat | A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer | Withdrawn | USA | 0 |
| NCT05023655 | Phase II | Tazemetostat | Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation | Terminated | USA | 0 |
| NCT05983965 | Phase I | Tazemetostat Acalabrutinib + Tazemetostat | Study of Tazemetostat in Lymphoid Malignancies | Terminated | USA | 0 |
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