Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Participants with follicular lymphoma (FL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.

Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.

Tazemetostat will be provided as a 200 mg oral tablet.

Tazemetostat

This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation.

Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

A Phase 2 Study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation

ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.

ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method.

PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.

PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.

DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.

TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.

TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.

TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).

Eisai Co., Ltd.

Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.

Participants With Follicular Lymphoma

Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.

Participants With Diffuse Large B-cell Lymphoma

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The safety analysis set included participants who received at least 1 administration of the study drug.

Eisai Inquiry Service

The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline.

Objective Response Rate (ORR) Based on Independent Reviewer Assessment

ORR Based on Investigator Assessment

Progression-free Survival (PFS) Based on Independent Reviewer Assessment

PFS Based on Investigator Assessment

The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Independent Reviewer Assessment.

Duration of Response (DOR) Based on Independent Reviewer Assessment

The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Investigator Assessment.

DOR Based on Investigator Assessment

Time to Response (TTR) Based on Independent Reviewer Assessment

TTR Based on Investigator Assessment

TEAEs

SAEs

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Participants with follicular lymphoma (FL) with the enhancer of zeste homolog 2 (EZH2) gene mutation received oral tazemetostat tablet at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until disease progression (PD), development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.

Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation	NCT03456726	Relapsed or Ref...	Tazemetostat	20 Years -	Eisai Inc.
Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation	NCT03456726	Relapsed or Ref...	Tazemetostat	20 Years -	Eisai Inc.

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