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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

TAZVERIK® EFFICACY DATA1

CLINICAL TRIAL OVERVIEW

TAZVERIK® efficacy and safety were evaluated in two open-label, single-arm cohorts (Cohort 4 and 5) of a multicenter study in patients with histologically confirmed follicular lymphoma after at least 2 prior systemic therapies (n=99). The primary efficacy endpoint was the overall response rate (ORR) and a secondary efficacy endpoint was duration of response (DOR).1,2

See Full Study Design

TAZVERIK DEMONSTRATED EFFICACY, REGARDLESS OF EZH2 MUTATION STATUS

Wild-Type EZH2 Follicular Lymphoma

EZH2 EZH2

Mutant ​EZH2 Follicular Lymphoma

EZH2 EZH2

*According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.

†Percentages are based on the Intent-to-Treat subjects within each group that achieved a complete response or partial response.

EXPLORATORY SUBANALYSIS OF THE PRIMARY ENDPOINT:
CHANGE IN TUMOR VOLUME

Wild-Type EZH2 Follicular Lymphoma

‡ The tumor volume was measured based on the maximum reduction in the sum of the products of the perpendicular diameters. Figure shown only includes patients (with 2+ prior systemic therapies) with baseline and post-baseline tumor measurements by the IRC; 1 patient did not have change from baseline.

Mutant EZH2 Follicular Lymphoma

§The tumor volume was measured based on the maximum reduction in the sum of the products of the perpendicular diameters.

LIMITATIONS: These additional data from the phase 2, single-arm study represent a subanalysis of maximum percent tumor volume change by participant. Tumor volume reduction is not equivalent to overall response, which requires at least 50% volume reduction and no new lesions per IWG-NHL criteria. Conclusions regarding the primary endpoint of the study should not be drawn from this representation of the data.

EZH2=enhancer of zeste homolog 2; WT=wild-type; MT=mutant-type; ORR=overall response rate; CI=confidence interval; DOR=duration of response; NE=not estimable; IRC=independent review committee.

References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020. 2. Data on file.

See how TAZVERIK was studied

in the clinical trial.

STUDY DESIGN

Learn more about how safety and tolerability were evaluated in the trial.

SAFETY & TOLERABILITY

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).

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.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS

TAZVERIK is indicated for the treatment of:

  • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
  • Adult patients with relapsed or refractory follicular lymphoma 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 a confirmatory trial(s).

Please see full Prescribing Information.

 

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TAZVERIK is a registered trademark of Epizyme, Inc, an Ipsen company.
IPSEN CARES is a registered trademark of Ipsen S.A.
All other trademarks and registered trademarks are property of their respective owners.

TAZVERIK is a registered trademark of Epizyme, Inc, an Ipsen company. IPSEN CARES is a registered trademark of Ipsen S.A. All other trademarks and registered trademarks are property of their respective owners.

TAZVERIK is a registered trademark of Epizyme, Inc, an Ipsen company.

IPSEN CARES is a registered trademark of Ipsen S.A.

All other trademarks and registered trademarks are property of their respective owners.

©2023 Ipsen Biopharmaceuticals, Inc. All rights reserved. TAZ-US-000086 05/23

©2023 Ipsen Biopharmaceuticals, Inc. All rights reserved. TAZ-US-000086 05/23