TAZVERIK® was studied in an open-label, single-arm, multicenter, phase 2 trial 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 criteria
R/R FL after ≥2 systemic therapies1 ECOG PS 0-21
Selected exclusion criteria2:
- 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 endpoint1,2:
Overall response rate (ORR) - Selected secondary endpoint1,2:
Median duration of response (DOR)
WT and MT EZH2 cohorts were analyzed independently and were not intended to be compared directly.
TAZVERIK was studied in a heavily pretreated FL patient population1
BASELINE DISEASE CHARACTERISTICS1,2 |
WT EZH2 (n=54) |
MT EZH2 (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 WT and MT EZH2 cohorts with more clinically challenging patients in the WT cohort.1,2
*ECOG PS was missing for one WT patient.
†And an alkylating agent or purine nucleoside antagonist.
EZH2=enhancer of zeste homologue 2; WT=wild-type; MT=mutant-type; IRC=independent review committee; ORR=overall response rate; DOR=duration of response; CI=confidence interval; NE=not estimable; 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. 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.
