CLINICAL TRIAL OVERVIEW
TAZVERIK efficacy and safety were evaluated in 2 open-label, single-arm cohorts (Cohorts 4 and 5) of a multicenter study in patients with histologically confirmed follicular lymphoma after at least 2 prior systemic therapies (n=99). The primary efficacy endpoint was the overall response rate (ORR) and a secondary efficacy endpoint was duration of response (DOR).1,2
WT
TAZVERIK demonstrated efficacy in EZH2 wild-type patients1
Overall response rate
(ORR, primary endpoint)1,3*
Duration of response
(DOR, secondary endpoint)1,3
(range: 1.0-≥22.5 months)
(n=18/53; 95% CI: 5.6-NE)1,2
Of those patients who had a response,3†
- 56% (n=10/18) responded for >6 months
- 39% (n=7/18) responded for >12 months
Median time to overall response for patients with EZH2 WT FL was 3.9 months (range: 1.6 to 16.3)1
- *According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.1
- †Percentages are based on the intent-to-treat patients within each group who achieved a complete response or partial response.3
MT
TAZVERIK demonstrated efficacy
in EZH2 mutant-type patients1
Overall response rate
(ORR, primary endpoint)1,3*
Duration of response
(DOR, secondary endpoint)1,3
(range: 0.0-≥22.1)
(n=29/42; 95% CI: 7.2-NE)1,2
Of those patients who had a response,3†
- 59% (n=17/29) responded for >6 months
- 21% (n=6/29) responded for >12 months
Median time to overall response for patients with EZH2 MT FL was 3.7 months (range: 1.6 to 10.9)1
- *According to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria as assessed by Independent Review Committee.1
- †Percentages are based on the intent-to-treat patients within each group who achieved a complete response or partial response.3
EZH2=enhancer of zeste homolog 2; WT=wild type; CI=confidence interval; NE=not evaluable; MT=mutant type.
References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., December 2023. 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.
WT
Additional data: Secondary endpoint of a single-arm study2
Progression-Free Survival (PFS) in EZH2 WT Cohort2*
Median PFS 11.1 Months2
(95% CI: 3.7-14.6)
LIMITATIONS: PFS was a prespecified secondary endpoint in the phase 2, single-arm, open-label study. PFS data is not included in the Prescribing Information. PFS data is descriptive and should be interpreted with caution. No conclusions of statistical significance can be drawn.2
*PFS was defined as the time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. PFS was analyzed using Kaplan-Meier methods at 6, 12, 18, and 24 months. The shaded areas represent 95% simultaneous confidence bands.2,3
Exploratory subanalysis of the primary endpoint: Changes in tumor volume3
*The tumor volume was measured based on the maximum reduction in the sum of the products of the perpendicular diameters. Figure shown only includes patients (with 2+ prior systemic therapies) with baseline and post-baseline tumor measurements by the IRC; 1 patient did not have change from baseline.3
LIMITATIONS: These additional data from the single-arm phase 2 study represent a subanalysis of maximum percent tumor volume change by participant. Tumor volume reduction is not equivalent to overall response, which requires at least 50% volume reduction and no new lesions per IWG-NHL criteria. Conclusions regarding the primary endpoint of the study should not be drawn from this representation of the data.3
MT
Additional data: Secondary endpoint of a single-arm study2
Progression-Free Survival (PFS) in EZH2 MT Cohort2*
Median PFS 13.8 Months2
(95% CI: 10.7-22.0)
LIMITATIONS: PFS was a prespecified secondary endpoint in the phase 2, single-arm, open-label study. PFS data is not included in the Prescribing Information. PFS data is descriptive and should be interpreted with caution. No conclusions of statistical significance can be drawn.2
* PFS was defined as the time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. PFS was analyzed using Kaplan-Meier methods at 6, 12, 18, and 24 months. The shaded areas represent 95% simultaneous confidence bands.2,3
Exploratory subanalysis of the primary endpoint: Changes in tumor volume3
*The tumor volume was measured based on the maximum reduction in the sum of the products of the perpendicular diameters.3
LIMITATIONS: These additional data from the single-arm phase 2 study represent a subanalysis of maximum percent tumor volume change by participant. Tumor volume reduction is not equivalent to overall response, which requires at least 50% volume reduction and no new lesions per IWG-NHL criteria. Conclusions regarding the primary endpoint of the study should not be drawn from this representation of the data.3
EZH2=enhancer of zeste homolog 2; WT=wild type; CI=confidence interval; IRC=Independent Review Committee; IWG-NHL=International Working Group Non-Hodgkin Lymphoma; MT=mutant type.
References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., December 2023. 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.
