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Study design: A single-arm, phase 2 trial of relapsed or refractory (R/R) follicular lymphoma (FL) patients

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

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 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

BASELINE
DISEASE
CHARACTERISTICS1,2
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
6.3
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, %
20
28
Refractory to last therapy, %
49
41
Prior stem cell transplant, %
9
39

*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.