TAZVERIK® (tazemetostat) 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 MT (n=45) and WT (n=54) 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%)
R/R FL after ≥2 systemic therapies1
MT: Median age: 62 (38-80); 42% male1 WT: Median age: 61 (36-87); 63% male1
- 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 22 months (MT; range 3 to 44) and 36 months (WT; range 32 to 39)1
- Primary endpoint:Overall response rate (ORR)1
- Selected secondary endpoint:Median duration of response (DOR)1
TAZVERIK was studied in a heavily pretreated FL patient population1
(1 to 11)
(1 to 8)
*ECOG PS was missing for one WT patient.
†And an alkylating agent or purine nucleoside antagonist.
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. 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.