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, and potentially leading to inhibition of cell proliferation and tumor growth (PMID: 23620515). Tazverik (tazemetostat) is FDA approved for use in patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, and in adult patients with relapsed or refractory follicular lymphoma (R/R FL) harboring an EZH2 mutation after 2 prior therapies, and in patients with R/R FL without treatment options (FDA.gov).

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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, and potentially leading to inhibition of cell proliferation and tumor growth (PMID: 23620515). Tazverik (tazemetostat) is FDA approved for use in patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, and in adult patients with relapsed or refractory follicular lymphoma (R/R FL) harboring an EZH2 mutation after 2 prior therapies, and in patients with R/R FL without treatment options (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 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
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
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
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 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 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...
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 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 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...
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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03348631 Phase II Tazemetostat Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer Active, not recruiting USA 0
NCT05983965 Phase I Tazemetostat Acalabrutinib + Tazemetostat Study of Tazemetostat in Lymphoid Malignancies Recruiting USA 0
NCT06575686 Phase II Tazemetostat Epcoritamab-bysp + Tazemetostat Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma Not yet recruiting USA 0
NCT04917042 Phase II Tazemetostat Tazemetostat in Malignant Peripheral Nerve Sheath Tumors Recruiting USA 0
NCT02875548 Phase II Tazemetostat Tazemetostat Rollover Study (TRuST): An Open-Label Rollover Study Enrolling by invitation USA | POL | GBR | FRA | BEL | AUS 1
NCT03217253 Phase I Tazemetostat Tazemetostat in Treating Patients With Metastatic or Unresectable Solid Tumors or B-Cell Lymphomas With Liver Dysfunction Withdrawn USA 0
NCT04241835 Phase I Tazemetostat A Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies Recruiting USA | SVK | POL | FRA | BEL 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) Active, not recruiting USA 1
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
NCT05567679 Phase I Tazemetostat A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer Withdrawn USA 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 Recruiting USA 0
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib 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) Recruiting USA | CAN | AUS 1
NCT02860286 Phase II Tazemetostat Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma Completed USA | GBR | FRA 0
NCT05467748 Phase Ib/II Tazemetostat EZH2 Inhibitor, Tazemetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer Not yet recruiting USA 0
NCT05023655 Phase II Tazemetostat Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation Recruiting USA 0
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 Recruiting USA 0


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