Marginal Zone Lymphoma, MZL
Conditions
Keywords
BGB-3111, Zanubrutinib
Brief summary
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Interventions
DRUGZanubrutinib
Zanubrutinib at a dose of 160 mg orally twice a day (BID)
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age 18 years or older 2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes 3. Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment 4. Current need for systemic therapy for MZL 5. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) 6. Eastern Cooperative Oncology Group (ECOG) of 0-2 7. Life expectancy ≥ 6 months 8. Adequate bone marrow function 9. Adequate organ function 10. Male and female participants must use highly effective methods of contraception Key
Exclusion criteria
1. Known transformation to aggressive lymphoma, eg, large cell lymphoma 2. Clinically significant cardiovascular disease 3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer 4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 5. History of stroke or intracranial hemorrhage 6. Severe or debilitating pulmonary disease 7. Active fungal, bacterial and/or viral infection requiring systemic therapy 8. Known central nervous system involvement by lymphoma 9. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection 10. Major surgery within 4 weeks of the first dose of study drug 11. Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor 12. Pregnant or lactating women 13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer 14. Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment | Up to approximately 3 years and 2.5 months | ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the Lugano Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT) | Up to approximately 3 years and 2.5 months | ORR is defined as the percentage of participants with complete and partial response as the best overall response, as determined by an IRC using PET-CT assessment data for participants with fluorodeoxyglucose (FDG)-avid disease |
| Progression-free Survival (PFS) by Investigator Assessment | Up to approximately 3 years and 2.5 months | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using Lugano Classification |
| PFS Event-Free Rate by Investigator Assessment | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for PFS at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
| PFS by IRC Assessment | Up to approximately 3 years and 2.5 months | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an IRC using Lugano Classification |
| PFS Event-Free Rate by IRC Assessment | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for PFS at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
| Overall Survival (OS) | Up to approximately 3 years and 2.5 months | OS is defined as the time from first study drug administration to the date of death due to any cause |
| OS Event-Free Rate | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | OS is defined as the time from first study drug administration to the date of death due to any cause. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for OS at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
| Duration of Response (DOR) by Investigator Assessment | Up to approximately 3 years and 2.5 months | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification. |
| DOR Event-Free Rate by Investigator Assessment | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
| DOR by IRC Assessment | Up to approximately 3 years and 2.5 months | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification. |
| DOR Event-Free Rate by IRC Assessment | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
| Time to Treatment Failure (TTF) | Up to approximately 3 years and 2.5 months | TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason. |
| ORR by Investigator Assessment | Up to approximately 3 years and 2.5 months | ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by the investigator using the Lugano Classification. |
| Time to Next Line of Therapy | Up to approximately 3 years and 2.5 months | Time to next line of therapy is defined as the time from study treatment start to the start of the first subsequent therapy for MZL |
| Time to Next Line of Therapy Event-Free Rate | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | Time to next line of therapy is defined as the time from study treatment start to the start of the first subsequent therapy for MZL. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for time to next line of therapy at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
| Time to Response (TTR) by Investigator Assessment | Up to approximately 3 years and 2.5 months | TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as assessed by the investigator using Lugano Classification |
| TTR by IRC Assessment | Up to approximately 3 years and 2.5 months | TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by the IRC using Lugano Classification. |
| Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Baseline to Cycle 30 (28 days per cycle) | Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' Positive change from baseline indicates improved health. |
| Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Baseline to Cycle 30 (28 days per cycle) | Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a positive score from baseline indicating improved health. |
| Number of Participants With Adverse Events | From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs |
| Area Under the Curve From Time 0 to 6 Hours (AUC0-6) | Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle) | — |
| Apparent Oral Clearance (CL/F) of Zanubrutinib | Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle) | — |
| Maximum Observed Concentration (Cmax) | Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle) | — |
| Elimination Half Life (t1/2) | Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle) | — |
| TTF Event-Free Rate | Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported | TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for TTF at 24 months with 95% confidence intervals estimated using Greenwood's formula. |
Countries
Australia, China, Czechia, France, Italy, New Zealand, South Korea, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 31 study centers in 9 countries.
Pre-assignment details
The study was composed of an initial screening phase (up to 35 days), a single-arm treatment phase, and a follow-up phase. A total of 38 participants rolled over to BGB-3111-LTE1 (NCT04170283) after study completion.
Participants by arm
| Arm | Count |
|---|---|
| Zanubrutinib Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 13 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Zanubrutinib |
|---|---|
| Age, Continuous | 67.9 Years STANDARD_DEVIATION 11.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants |
| Race/Ethnicity, Customized Not Reported | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 40 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 68 |
| other Total, other adverse events | 61 / 68 |
| serious Total, serious adverse events | 30 / 68 |
Outcome results
Primary
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the Lugano Classification
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment | 68.2 Percentage of participants |
p-value: <0.0001Binomial exact method
Secondary
Apparent Oral Clearance (CL/F) of Zanubrutinib
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Population: Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zanubrutinib | Apparent Oral Clearance (CL/F) of Zanubrutinib | 215.3 Liters/hour | Standard Deviation 114.8 |
Secondary
Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Population: Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zanubrutinib | Area Under the Curve From Time 0 to 6 Hours (AUC0-6) | 868.0 Hour*ng/mL | Standard Deviation 304.3 |
Secondary
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a positive score from baseline indicating improved health.
Time frame: Baseline to Cycle 30 (28 days per cycle)
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 3 | 7.471 Score on a scale | Standard Deviation 19.5396 |
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 6 | 7.823 Score on a scale | Standard Deviation 15.8121 |
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 9 | 5.382 Score on a scale | Standard Deviation 20.0833 |
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 12 | 7.143 Score on a scale | Standard Deviation 17.3216 |
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 18 | 10.677 Score on a scale | Standard Deviation 18.4811 |
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 24 | 9.286 Score on a scale | Standard Deviation 19.2561 |
| Zanubrutinib | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Cycle 30 | 6.250 Score on a scale | Standard Deviation 20.491 |
Secondary
Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)
Mean change from baseline in EQ-5D-5L VAS. The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' Positive change from baseline indicates improved health.
Time frame: Baseline to Cycle 30 (28 days per cycle)
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 3 | 1.0 Score on a scale | Standard Deviation 18.18 |
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 6 | 2.2 Score on a scale | Standard Deviation 15.78 |
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 9 | 0.2 Score on a scale | Standard Deviation 16.28 |
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 12 | 2.8 Score on a scale | Standard Deviation 16.15 |
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 18 | 5.6 Score on a scale | Standard Deviation 17.68 |
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 24 | 5.8 Score on a scale | Standard Deviation 15.24 |
| Zanubrutinib | Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) | Cycle 30 | 1.6 Score on a scale | Standard Deviation 18.15 |
Secondary
DOR by IRC Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification.
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | DOR by IRC Assessment | NA Months |
Secondary
DOR Event-Free Rate by Investigator Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | DOR Event-Free Rate by Investigator Assessment | 60.8 Percentage of participants |
Secondary
DOR Event-Free Rate by IRC Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | DOR Event-Free Rate by IRC Assessment | 72.9 Percentage of participants |
Secondary
Duration of Response (DOR) by Investigator Assessment
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification.
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Duration of Response (DOR) by Investigator Assessment | NA Months |
Secondary
Elimination Half Life (t1/2)
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Population: Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Elimination Half Life (t1/2) | 1.2 Hours |
Secondary
Maximum Observed Concentration (Cmax)
Time frame: Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle)
Population: Pharmacokinetic analysis set included all participants who had at least 1 postdose zanubrutinib plasma concentration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zanubrutinib | Maximum Observed Concentration (Cmax) | 315.5 nanograms/milliliter | Standard Deviation 120.2 |
Secondary
Number of Participants With Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs
Time frame: From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Population: Safety analysis set is all participants who were enrolled and received at least 1 dose of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zanubrutinib | Number of Participants With Adverse Events | At least one TEAE | 68 Participants |
| Zanubrutinib | Number of Participants With Adverse Events | At least one SAE | 30 Participants |
Secondary
ORR by Investigator Assessment
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by the investigator using the Lugano Classification.
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | ORR by Investigator Assessment | 75.8 Percentage of participants |
Secondary
ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
ORR is defined as the percentage of participants with complete and partial response as the best overall response, as determined by an IRC using PET-CT assessment data for participants with fluorodeoxyglucose (FDG)-avid disease
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of evaluable participants with FDG-avid disease at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT) | 69.5 Percentage of participants |
Secondary
OS Event-Free Rate
OS is defined as the time from first study drug administration to the date of death due to any cause. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for OS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | OS Event-Free Rate | 85.9 Percentage of participants |
Secondary
Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Overall Survival (OS) | NA Months |
Secondary
PFS by IRC Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an IRC using Lugano Classification
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | PFS by IRC Assessment | NA Months |
Secondary
PFS Event-Free Rate by Investigator Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for PFS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | PFS Event-Free Rate by Investigator Assessment | 57.9 Percentage of participants |
Secondary
PFS Event-Free Rate by IRC Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using Lugano Classification. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for PFS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | PFS Event-Free Rate by IRC Assessment | 70.9 Percentage of participants |
Secondary
Progression-free Survival (PFS) by Investigator Assessment
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using Lugano Classification
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Progression-free Survival (PFS) by Investigator Assessment | NA Months |
Secondary
Time to Next Line of Therapy
Time to next line of therapy is defined as the time from study treatment start to the start of the first subsequent therapy for MZL
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Time to Next Line of Therapy | NA Months |
Secondary
Time to Next Line of Therapy Event-Free Rate
Time to next line of therapy is defined as the time from study treatment start to the start of the first subsequent therapy for MZL. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for time to next line of therapy at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | Time to Next Line of Therapy Event-Free Rate | 74.5 Percentage of participants |
Secondary
Time to Response (TTR) by Investigator Assessment
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as assessed by the investigator using Lugano Classification
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; TTR was summarized for responders only, defined as participants with a best overall response of partial response or above.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Time to Response (TTR) by Investigator Assessment | 2.79 Months |
Secondary
Time to Treatment Failure (TTF)
TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason.
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | Time to Treatment Failure (TTF) | 27.8 Months |
Secondary
TTF Event-Free Rate
TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for TTF at 24 months with 95% confidence intervals estimated using Greenwood's formula.
Time frame: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zanubrutinib | TTF Event-Free Rate | 53.0 Percentage of participants |
Secondary
TTR by IRC Assessment
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by the IRC using Lugano Classification.
Time frame: Up to approximately 3 years and 2.5 months
Population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; TTR was summarized for responders only, defined as participants with a best overall response of partial response or above.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zanubrutinib | TTR by IRC Assessment | 2.79 Months |