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TAZVERIK® (tazemetostat) WAS STUDIED IN THE LARGEST, GLOBAL PROSPECTIVE TRIAL IN PATIENTS WITH EPITHELIOID SARCOMA (N=62)1,2

Study design

A cohort of histologically confirmed, metastatic or locally advanced epithelioid sarcoma patients from an open-label, single-arm, multicenter Phase 2 study (EZH-202)1-3

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Patient population

Baseline disease characteristics in patients in the Phase 2 study1

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44%

had proximal disease

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77%

had prior surgery for the disease

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61%

had prior systemic chemotherapy

There are currently no other FDA-approved treatments exclusively or specifically indicated for locally advanced or metastatic epithelioid sarcoma.2,4,5

Clinical trial results

Overall response rate (primary endpoint)1,2✝︎

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Time to response for patients who achieved an overall response1

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Duration of response (secondary endpoint)1

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Tazemetostat (TAZVERIK®) is recommended in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as an option for appropriate patients over 16 years of age with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.6‡

ECOG PS=Eastern Cooperative Oncology Group Performance Status; ORR=overall response rate; DOR=duration of response; CI=confidence interval.

*Exception: disease-free for 5 years, or with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma was eligible.2

✝︎Confirmed complete response + confirmed partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR).1

‡Please see the complete version of the NCCN Guidelines® for Soft Tissue Sarcomas (V.2.2020) available on NCCN.org for specific recommendations.

References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020. 2. Data on file. 3. Stacchiotti S, Schöffski P, Jones RL, et al. Safety and efficacy of tazemetostat, a first-in-class EZH2 inhibitor, in patients with epithelioid sarcoma (ES)(NCT02601950). American Society of Clinical Oncology (ASCO). 2019. 4. Touati N, Schöffski P, Litière S, et al. European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Experience with Advanced/Metastatic Epithelioid Sarcoma Patients Treated in Prospective Trials: Clinical Profile and Response to Systemic Therapy. Clin Oncol (R Coll Radiol). 2018;30(7):448-454. 5. Siontis BL, Chugh R, and Schuetze SM. The potential of emerging therapeutics for epithelioid sarcoma. Expert Opin Orphan Drugs. 2017;5(12):983-989. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed July 8, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Learn more about
how TAZVERIK works.

mechanism of action

Learn more about how safety was evaluated in the
Phase 2 study in epithelioid sarcoma patients.

safety & tolerability
INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T‑cell lymphoblastic lymphoma (T‑LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug‑associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose‑dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0‑45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

Before prescribing TAZVERIK, please read the full Prescribing Information.