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TAZVERIK® (tazemetostat)
was studied in a heavily pretreated Follicular Lymphoma patient population1

Clinical trial results

TAZVERIK achieved overall response rates of 69% in patients with MT EZH2 and 34% in patients with WT EZH21

response rate response rate
Complete Response
Partial Response

*According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by independent review committee.

TAZVERIK demonstrated sustained efficacy in a heavily pretreated population, regardless of EZH2 mutation status1

response rates response rates

Of those who responded:

MT EZH2
59%(n=17/29) responded
for
≥6 months
21%(n=6/29) responded
for
≥12 months
WT EZH2
56%(n=10/18) responded
for
≥6 months
39%(n=7/18) responded
for
≥12 months

Median time to response for patients with MT EZH2 was 3.7 months (range: 1.6 to 10.9). Median time to response for patients with WT EZH2 was 3.9 months (range: 1.6 to 16.3).1

†95% CI for MT EZH2 : 7.2–NE. 95% CI for WT EZH2 : 5.6–NE.
‡Percentages are based on the Intent-to-Treat subjects within each group that achieved CR or PR.

Study design

TAZVERIK was studied in an open-label, single-arm, multicenter, phase 2 trial with 6 cohorts of patients, including 2 cohorts with histologically-confirmed relapsed or refractory (R/R) follicular lymphoma (FL)1,2

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

  • EZH2 mutations were identified prospectively by central testing using the cobas® EZH2 Mutation Test
  • Patients in the EZH2 MT cohort had the following mutations: Y646X [S,H,C] (36%), Y646F (29%), Y646N (27%), A682G (11%), and A692V (2%)

R/R FL after ≥2 systemic therapies1

MT: Median age: 62 (38-80); 42% male1 WT: Median age: 61 (36-87); 63% male1

Selected exclusion criteria2:

  • Noncutaneous malignancies other than B-cell lymphomas
  • Leptomeningeal metastases or brain metastases or history of previously treated brain metastases
  • Thrombocytopenia, neutropenia, or anemia of Grade ≥3 and any prior history of myeloid malignancies, including MDS

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 22 months (MT; range 3 to 44) and 36 months (WT; range 32 to 39)1

  • Primary endpoint1,2:Overall response rate (ORR)
  • Selected secondary endpoint1,2:Median duration of response (DOR)

Patient population

BASELINE
DISEASE
CHARACTERISTICS1‑3
MT EZH2 (n=45)
WT EZH2 (n=54)
ECOG PS 0 or 1, %
100
91
ECOG PS 2, %§
0
7
POD24, %
42
59
Median time from initial diagnosis, years
4.7
6.5
Median number of lines of prior systemic therapy (range)
2
(1 to 11)
3
(1 to 8)
Refractory to rituximab, %
49
59
Double refractory to rituximab and an alkylating agent, %
20
28
Refractory to last therapy, %
49
41
Prior stem cell transplant, %
9
39

§ECOG PS was missing for one WT patient.

MT=mutant-type; WT=wild-type; EZH2=enhancer of zeste homologue 2; ORR=overall response rate; CI=confidence interval; DOR=duration of response; NE=not estimable; MDS=myelodysplastic syndrome; IRC=independent review committee; ECOG PS=Eastern Cooperative Oncology Group Performance Status; POD24=early progression within 24 months following front-line therapy.

References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020. 2. Data on file. 3. Morschhauser F, Tilly H, Chaidos A, et al. Interim Update From a Phase 2 Multicenter Study of Tazemetostat, an EZH2 Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma. The International Conference on Malignant Lymphoma (ICML). 2019.

Learn more about how EZH2 inhibition
works in FL.

Mechanism of Action

Learn more about how safety was evaluated
in the phase 2 study.

Safety & Tolerability
INDICATIONS AND IMPORTANT SAFETY INFORMATION

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).

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 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.

Before prescribing TAZVERIK, please read the full Prescribing Information.