Trial Outcomes & Findings for Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma (NCT NCT03846427)
NCT ID: NCT03846427
Last Updated: 2024-10-26
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Up to approximately 3 years and 2.5 months
Results posted on
2024-10-26
Participant Flow
This study was conducted at 31 study centers in 9 countries.
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.
Participant milestones
| Measure |
Zanubrutinib
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Zanubrutinib
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Overall Study
Death
|
13
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Baseline characteristics by cohort
| Measure |
Zanubrutinib
n=68 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Age, Continuous
|
67.9 Years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
|
68.2 Percentage of participants
Interval 55.56 to 79.11
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
ORR by Investigator Assessment
|
75.8 Percentage of participants
Interval 63.64 to 85.46
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of evaluable participants with FDG-avid disease at baseline
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
Outcome measures
| Measure |
Zanubrutinib
n=59 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
|
69.5 Percentage of participants
Interval 56.13 to 80.81
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Progression-free Survival (PFS) by Investigator Assessment
|
NA Months
Interval 16.5 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
PFS Event-Free Rate by Investigator Assessment
|
57.9 Percentage of participants
Interval 44.83 to 68.86
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
PFS by IRC Assessment
|
NA Months
Interval 27.6 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
PFS Event-Free Rate by IRC Assessment
|
70.9 Percentage of participants
Interval 57.2 to 80.95
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
OS is defined as the time from first study drug administration to the date of death due to any cause
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Overall Survival (OS)
|
NA Months
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
OS Event-Free Rate
|
85.9 Percentage of participants
Interval 74.7 to 92.4
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=50 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Duration of Response (DOR) by Investigator Assessment
|
NA Months
Interval 22.1 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=50 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
DOR Event-Free Rate by Investigator Assessment
|
60.8 Percentage of participants
Interval 44.8 to 73.6
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=45 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
DOR by IRC Assessment
|
NA Months
Interval 25.0 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=45 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
DOR Event-Free Rate by IRC Assessment
|
72.9 Percentage of participants
Interval 54.4 to 84.9
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
TTF is defined as the time from study treatment start to the date of discontinuation of study drug due to any reason.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Time to Treatment Failure (TTF)
|
27.8 Months
Interval 14.7 to
Not estimable due to insufficient number of participants with events and high censoring rate for time-to-event variable
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
TTF Event-Free Rate
|
53.0 Percentage of participants
Interval 40.4 to 64.2
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Time to Next Line of Therapy
|
NA Months
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 years and 2.5 months after first participant enrolled; Month 24 reportedPopulation: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Time to Next Line of Therapy Event-Free Rate
|
74.5 Percentage of participants
Interval 61.7 to 83.6
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: 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.
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
Outcome measures
| Measure |
Zanubrutinib
n=50 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Time to Response (TTR) by Investigator Assessment
|
2.79 Months
Interval 1.7 to 16.6
|
SECONDARY outcome
Timeframe: Up to approximately 3 years and 2.5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=45 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
TTR by IRC Assessment
|
2.79 Months
Interval 1.7 to 11.1
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Zanubrutinib
n=66 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 20.4910
|
SECONDARY outcome
Timeframe: 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
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs
Outcome measures
| Measure |
Zanubrutinib
n=68 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Number of Participants With Adverse Events
At least one TEAE
|
68 Participants
|
|
Number of Participants With Adverse Events
At least one SAE
|
30 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Zanubrutinib
n=9 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Area Under the Curve From Time 0 to 6 Hours (AUC0-6)
|
868.0 Hour*ng/mL
Standard Deviation 304.3
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Apparent Oral Clearance (CL/F) of Zanubrutinib
|
215.3 Liters/hour
Standard Deviation 114.8
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Zanubrutinib
n=11 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Maximum Observed Concentration (Cmax)
|
315.5 nanograms/milliliter
Standard Deviation 120.2
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Zanubrutinib
n=9 Participants
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Elimination Half Life (t1/2)
|
1.2 Hours
Interval 0.8 to 2.7
|
Adverse Events
Zanubrutinib
Serious events: 30 serious events
Other events: 61 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Zanubrutinib
n=68 participants at risk
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Atrial flutter
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Faecaloma
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Asthenia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Chest pain
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Bile duct stone
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19 pneumonia
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Cellulitis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Influenza
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pyelonephritis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Septic encephalopathy
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Tuberculosis
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
2/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Cerebellar infarction
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Ischaemic stroke
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Sciatica
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Syncope
|
2.9%
2/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
Other adverse events
| Measure |
Zanubrutinib
n=68 participants at risk
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.8%
6/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.3%
7/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
8/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
12/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.1%
15/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dysphagia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
7/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Toothache
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Fatigue
|
8.8%
6/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Oedema peripheral
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
11.8%
8/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19
|
8.8%
6/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Oral herpes
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Tonsillitis
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.2%
9/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Contusion
|
23.5%
16/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Alanine aminotransferase increased
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil count decreased
|
7.4%
5/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
Weight decreased
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
5/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.7%
10/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
8/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Dizziness
|
7.4%
5/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Lethargy
|
5.9%
4/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Paraesthesia
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Sciatica
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Psychiatric disorders
Anxiety
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
7/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypertension
|
4.4%
3/68 • From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy, whichever occurred first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER