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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

Study design: AN OPEN-LABEL 
single-arm phase 2 trial of relapsed 
or refractory (R/R) follicular 
lymphoma (FL) patients1,2

Study design: AN OPEN-LABEL 
single-arm phase 2 trial of 
relapsed or refractory (R/R) 
follicular lymphoma (FL) 
patients1,2

TAZVERIK® was studied with 6 cohorts of patients, including 2 cohorts with histologically confirmed R/R FL1,2

Enrolled 2 cohorts: EZH2 WT (n=54) and MT (n=45) patients1

  • Patients in the EZH2 MT cohort had the following mutations: Y646X [S,H,C] (36%), Y646F (29%), Y646N (27%), A682G (11%), and A692V (2%)

Selected inclusion criteria1:

  • R/R FL after ≥2 systemic therapies
  • ECOG PS 0-2

Selected exclusion criteria3:

  • Noncutaneous malignancies other than B-cell lymphomas
  • Leptomeningeal metastases or brain metastases
  • Thrombocytopenia, neutropenia, or anemia of Grade ≥3

 

TAZVERIK dosing was 
800 mg (4 tablets x 200 mg) 
twice daily until confirmed 
disease progression or 
unacceptable toxicity1

Assessments by IRC every 8 weeks through 24 weeks, then every 12 weeks1

Median duration of follow-up was 36 months (WT; range: 32 to 39) and 22 months (MT; range: 3 to 44)1

 

  • Primary endpoint1: 
    Overall response rate (ORR)
  • Selected secondary endpoint1: 
    Median duration of response (DOR)

 

EZH2 WT and MT cohorts were analyzed independently and were not intended to be compared directly.1

TAZVERIK was studied in a heavily pretreated FL patient population1

BASELINE DISEASE CHARACTERISTICS1,2

EZH2 WT (n=54)

EZH2 MT (n=45)

ECOG PS 0 or 1, %

91

100

ECOG PS 2, %*

7

0

POD24, %

59

42

Median time from initial diagnosis, years

6.3

4.7

Median number of lines of prior systemic therapy (range)

3 (1 to 8)

2 (1 to 11)

Refractory to rituximab, %

59

49

Double refractory to rituximab, %†

28

20

Refractory to last therapy, %

41

49

Prior stem cell transplant, %

39

9

Baseline characteristics were notably different across the EZH2 WT and MT cohorts with more clinically challenging patients in the WT cohort.1,2

Baseline characteristics were 
notably different across the 
EZH2 WT and MT cohorts 
with more clinically challenging 
patients in the WT cohort.1,2

*ECOG PS was missing for one WT patient.3

†And an alkylating agent or purine nucleoside antagonist.2

EZH2=enhancer of zeste homolog 2; WT=wild type; MT=mutant type; ECOG PS=Eastern Cooperative Oncology Group Performance Status; IRC=Independent Review Committee; POD24=early progression within 24 months following front-line therapy.

References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., August 2024. 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.

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See how TAZVERIK demonstrated efficacy, regardless of EZH2 mutation status.

CLINICAL TRIAL RESULTS

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 strong or moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate or 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.