Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Conditions
Keywords
EZH2 gene mutation, Tazemetostat, Diffuse large B-cell lymphoma, Follicular lymphoma
Brief summary
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.
Interventions
DRUGTazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows: * Cohort 1: Follicular lymphoma (FL) * Cohort 2: Diffuse large B-cell lymphoma (including primary mediastinal B-cell lymphoma and transformed FL) * Participants who have confirmed EZH2 gene mutation of tumor in central laboratory * Participants who have measurable disease * Participants who had previous therapy with systemic chemotherapy and/or antibody therapy and for which no standard therapy exists * Participants who had progressive disease or did not have response (complete response or partial response) in previous systemic therapy, or relapsed or progressed after previous systemic therapy * Participants with Eastern Cooperative Oncology Group performance status of 0 to 1 * Participants with life expectancy of ≥3 months from starting study drug administration * Participants with adequate renal, liver, and bone marrow function * Male and female participants ≥20 years of age at the time of informed consent * Participants who has provided written consent to participate in the study
Exclusion criteria
* Participants with prior exposure to EZH2 inhibitor * Participants with a history or a presence of central nerves invasion * Participants with malignant pleural effusion, cardiac effusion, or ascites retention * Participants with allogeneic stem cell transplantation * Participants with medical need for the continued use of potent inhibitors of Cytochrome P450 3A (CYP3A)or potent inducer of CYP3A (including St. John's wort) * Participants with significant cardiovascular impairment · Participants with prolongation of corrected QT interval using Fridericia's formula to \> 480 milliseconds (msec) * Participants with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug * Participants with complications of hepatic cirrhosis, interstitial pneumonia or pulmonary fibrosis * Participants with active infection requiring systemic therapy * Women of childbearing potential or man of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later (for males 90 days later) from last administration of study drug * Woman who are pregnant or breastfeeding * Participants who were deemed as inappropriate to participate in the study by the investigator or sub-investigator * Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myeloid malignancies, including myelodysplastic syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Based on Independent Reviewer Assessment | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) | 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 Based on Investigator Assessment | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) Based on Independent Reviewer Assessment | From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months) | 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. |
| DOR Based on Investigator Assessment | From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months) | 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. |
| Progression-free Survival (PFS) Based on Independent Reviewer Assessment | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) | 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. |
| TTR Based on Investigator Assessment | From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months) | 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. |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months) | 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). |
| Time to Response (TTR) Based on Independent Reviewer Assessment | From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months) | 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. |
| PFS Based on Investigator Assessment | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 28 investigative sites in Japan from 09 April 2018 to 17 December 2021.
Pre-assignment details
A total of 100 participants were screened, of which 80 were screen failures and only 20 participants were eligible to enter the study and received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Follicular Lymphoma 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. | 17 |
| Participants With Diffuse Large B-cell 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. | 3 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Discontinued from study due to switch to commercial tazemetostat | 6 | 0 |
| Overall Study | Disease Progression | 6 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Participants With Diffuse Large B-cell Lymphoma | Total | Participants With Follicular Lymphoma |
|---|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 7.23 | 67.1 years STANDARD_DEVIATION 9.41 | 65.8 years STANDARD_DEVIATION 9.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 20 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 20 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 11 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 3 |
| other Total, other adverse events | 17 / 17 | 3 / 3 |
| serious Total, serious adverse events | 8 / 17 | 1 / 3 |
Outcome results
Primary
Objective Response Rate (ORR) Based on Independent Reviewer Assessment
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.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Follicular Lymphoma | Objective Response Rate (ORR) Based on Independent Reviewer Assessment | 76.5 percentage of participants |
| Participants With Diffuse Large B-cell Lymphoma | Objective Response Rate (ORR) Based on Independent Reviewer Assessment | 100.0 percentage of participants |
Primary
ORR Based on Investigator Assessment
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.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Follicular Lymphoma | ORR Based on Investigator Assessment | 70.6 percentage of participants |
| Participants With Diffuse Large B-cell Lymphoma | ORR Based on Investigator Assessment | 66.7 percentage of participants |
Secondary
DOR Based on Investigator Assessment
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.
Time frame: From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Follicular Lymphoma | DOR Based on Investigator Assessment | 35.8 months |
| Participants With Diffuse Large B-cell Lymphoma | DOR Based on Investigator Assessment | NA months |
Secondary
Duration of Response (DOR) Based on Independent Reviewer Assessment
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.
Time frame: From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Follicular Lymphoma | Duration of Response (DOR) Based on Independent Reviewer Assessment | NA months |
| Participants With Diffuse Large B-cell Lymphoma | Duration of Response (DOR) Based on Independent Reviewer Assessment | 13.8 months |
Secondary
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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).
Time frame: From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
Population: The safety analysis set included participants who received at least 1 administration of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Follicular Lymphoma | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 17 Participants |
| Participants With Follicular Lymphoma | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 8 Participants |
| Participants With Diffuse Large B-cell Lymphoma | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 3 Participants |
| Participants With Diffuse Large B-cell Lymphoma | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
Secondary
PFS Based on Investigator Assessment
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.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Follicular Lymphoma | PFS Based on Investigator Assessment | NA months |
| Participants With Diffuse Large B-cell Lymphoma | PFS Based on Investigator Assessment | 26.7 months |
Secondary
Progression-free Survival (PFS) Based on Independent Reviewer Assessment
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.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Follicular Lymphoma | Progression-free Survival (PFS) Based on Independent Reviewer Assessment | NA months |
| Participants With Diffuse Large B-cell Lymphoma | Progression-free Survival (PFS) Based on Independent Reviewer Assessment | 15.7 months |
Secondary
Time to Response (TTR) Based on Independent Reviewer Assessment
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.
Time frame: From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Follicular Lymphoma | Time to Response (TTR) Based on Independent Reviewer Assessment | 3.64 months |
| Participants With Diffuse Large B-cell Lymphoma | Time to Response (TTR) Based on Independent Reviewer Assessment | 3.70 months |
Secondary
TTR Based on Investigator Assessment
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.
Time frame: From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants With Follicular Lymphoma | TTR Based on Investigator Assessment | 4.59 months |
| Participants With Diffuse Large B-cell Lymphoma | TTR Based on Investigator Assessment | 5.56 months |