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TAZVERIK® DEMONSTRATED EFFICACY, REGARDLESS OF EZH2 MUTATION STATUS1

TAZVERIK® DEMONSTRATED     
EFFICACY, REGARDLESS OF EZH2  
MUTATION STATUS1

CLINICAL TRIAL OVERVIEW

TAZVERIK efficacy and safety were evaluated in 2 open-label, single-arm cohorts (Cohorts 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
    Study Endpoints

    WT

    TAZVERIK demonstrated efficacy in EZH2 wild-type patients​1

    Overall response rate 
    (ORR, primary endpoint)1,3*

    Duration of response 
    (DOR, secondary endpoint)1,3

    (range: 1.0-≥22.5 months) 
    (n=18/53; 95% CI: 5.6-NE)1,2

    Of those patients who had a response,3†

    • 56% (n=10/18) responded for >6 months
    • 39% (n=7/18) responded for >12 months

    Median time to overall response for patients with EZH2 WT FL was 3.9 months (range: 1.6 to 16.3)1

    • *According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.1
    • †Percentages are based on the intent-to-treat patients within each group who achieved a complete response or partial response.3

    MT

    TAZVERIK demonstrated efficacy 
    in EZH2 mutant-type patients​1

    Overall response rate 
    (ORR, primary endpoint)1,3*

    Duration of response 
    (DOR, secondary endpoint)1,3

    (range: 0.0-≥22.1) 
    (n=29/42; 95% CI: 7.2-NE)1,2

    Of those patients who had a response,3†

    • 59% (n=17/29) responded for >6 months
    • 21% (n=6/29) responded for >12 months

    Median time to overall response for patients with EZH2 MT FL was 3.7 months (range: 1.6 to 10.9)1

    • *According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.1
    • †Percentages are based on the intent-to-treat patients within each group who achieved a complete response or partial response.3

    EZH2=enhancer of zeste homolog 2; WT=wild type; CI=confidence interval; NE=not evaluable; MT=mutant type.

    References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., December 2023. 2. Morschhauser F, Tilly H, Chaidos A, et al. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020;21(11):1433-1442. doi:10.1016/S1470-2045(20)30441-1 3. Data on File.

    Additional Data

    WT

    Additional data: Secondary endpoint of a single-arm study2

    Progression-Free Survival (PFS) in EZH2 WT Cohort2*

    Median PFS 11.1 Months2

    (95% CI: 3.7-14.6)

    LIMITATIONS: PFS was a prespecified secondary endpoint in the phase 2, single-arm, open-label study. PFS data is not included in the Prescribing Information. PFS data is descriptive and should be interpreted with caution. No conclusions of statistical significance can be drawn.2

    *PFS was defined as the time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. PFS was analyzed using Kaplan-Meier methods at 6, 12, 18, and 24 months. The shaded areas represent 95% simultaneous confidence bands.2,3

    Exploratory subanalysis of the primary endpoint: Changes in tumor volume3

    *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.3

    LIMITATIONS: These additional data from the single-arm phase 2 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.3

    MT

    Additional data: Secondary endpoint of a single-arm study2

    Progression-Free Survival (PFS) in EZH2 MT Cohort2*

    Median PFS 13.8 Months2

    (95% CI: 10.7-22.0)

    LIMITATIONS: PFS was a prespecified secondary endpoint in the phase 2, single-arm, open-label study. PFS data is not included in the Prescribing Information. PFS data is descriptive and should be interpreted with caution. No conclusions of statistical significance can be drawn.2

    * PFS was defined as the time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. PFS was analyzed using Kaplan-Meier methods at 6, 12, 18, and 24 months. The shaded areas represent 95% simultaneous confidence bands.2,3

    Exploratory subanalysis of the primary endpoint: Changes in tumor volume3

    *The tumor volume was measured based on the maximum reduction in the sum of the products of the perpendicular diameters.3

    LIMITATIONS: These additional data from the single-arm phase 2 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.3

    EZH2=enhancer of zeste homolog 2; WT=wild type; CI=confidence interval; IRC=Independent Review Committee; IWG-NHL=International Working Group Non-Hodgkin Lymphoma; MT=mutant type.

    References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., December 2023. 2. Morschhauser F, Tilly H, Chaidos A, et al. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020;21(11):1433-1442. doi:10.1016/S1470-2045(20)30441-1 3. 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 758 adults who received TAZVERIK 800 mg twice daily as monotherapy, myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or B-cell acute lymphoblastic leukemia (B-ALL) occurred in 1.7% 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.