Trial Outcomes & Findings for Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib (NCT NCT05068440)
NCT ID: NCT05068440
Last Updated: 2026-03-25
Results Overview
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Results posted on
2026-03-25
Participant Flow
Participants were enrolled at 20 study centers in China.
Participants were screened, treated until discontinuation, and completed end-of-treatment and safety follow-up visits. Those who stopped treatment without disease progression continued tumor assessments. Long-term follow-up monitored survival, secondary malignancies, and subsequent therapies.
Participant milestones
| Measure |
Zanubrutinib
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
Treated
|
65
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Zanubrutinib
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Overall Study
Death
|
32
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study Completed by Sponsor
|
14
|
Baseline Characteristics
Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
Baseline characteristics by cohort
| Measure |
Zanubrutinib
n=65 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 9.88 • n=138 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
Asian
|
65 Participants
n=138 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (fully Active)
|
12 Participants
n=138 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Limited strenuous activity; light work possible)
|
43 Participants
n=138 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
2 (Self-care intact; no work; up >50% of day)
|
10 Participants
n=138 Participants
|
PRIMARY outcome
Timeframe: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 monthsPopulation: Safety Analysis Set
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).
Outcome measures
| Measure |
Zanubrutinib
n=65 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Overall Response Rate (ORR)
|
46.2 percentage of participants
Interval 33.7 to 59.0
|
SECONDARY outcome
Timeframe: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 monthsPopulation: Safety Analysis Set
CRR was defined as the percentage of participants who achieved a complete response as their best overall response, as determined by investigator assessment according to the Lugano classification for NHL.
Outcome measures
| Measure |
Zanubrutinib
n=65 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Complete Response Rate (CRR)
|
29.2 Percentage of Participants
Interval 18.6 to 41.8
|
SECONDARY outcome
Timeframe: From the date of first documented response until to the data cutoff date (31MAR2025). Maximum time on study was 36.4 monthsPopulation: Participants with a confirmed CR or PR
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=30 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Duration of Response (DOR)
|
22.7 Months
Interval 2.8 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 monthsPopulation: Safety Analysis Set
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment according to the Lugano classification for NHL. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=65 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Progression-free Survival (PFS)
|
4.3 Months
Interval 2.7 to 5.5
|
SECONDARY outcome
Timeframe: From first dose until disease progression or death, assessed up to the data cutoff date (31MAR2025). Maximum time on study was 36.4 monthsPopulation: Participants with a confirmed CR or PR
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by investigator assessment per the Lugano classification for NHL. Only participants who achieved an overall response were included in the analysis.
Outcome measures
| Measure |
Zanubrutinib
n=30 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Time to Response (TTR)
|
2.76 Months
Interval 0.9 to 5.5
|
SECONDARY outcome
Timeframe: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 monthsPopulation: Safety Analysis Set
OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Zanubrutinib
n=65 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Overall Survival (OS)
|
18.1 Months
Interval 11.4 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From the first dose until 30 days after the last dose of zanubrutinib, death, or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 monthsPopulation: Safety Analysis Set
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it was linked to the study drug.
Outcome measures
| Measure |
Zanubrutinib
n=65 Participants
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
At Least One SAE
|
16 Participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
At Least One TEAE
|
59 Participants
|
Adverse Events
Zanubrutinib
Serious events: 16 serious events
Other events: 57 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Zanubrutinib
n=65 participants at risk
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Abdominal adhesions
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Ileal perforation
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
General disorders
Chest discomfort
|
1.5%
1/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
General disorders
Sudden cardiac death
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Bacterial sepsis
|
1.5%
1/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
COVID-19 pneumonia
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Peritonitis
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Pneumonia
|
6.2%
4/65 • Number of events 6 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Pneumonia viral
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Platelet count decreased
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Psychiatric disorders
Completed suicide
|
1.5%
1/65 • Number of events 1 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
Other adverse events
| Measure |
Zanubrutinib
n=65 participants at risk
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
|
|---|---|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
4/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Blood bilirubin increased
|
9.2%
6/65 • Number of events 7 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Blood creatinine increased
|
9.2%
6/65 • Number of events 10 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Blood glucose increased
|
4.6%
3/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
4.6%
3/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
13/65 • Number of events 19 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Bile acids increased
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Blood and lymphatic system disorders
Anaemia
|
33.8%
22/65 • Number of events 33 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.6%
3/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
2/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
2/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Cardiac disorders
Cardiac failure
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
6/65 • Number of events 7 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Anal fissure
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Ascites
|
4.6%
3/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Gingival swelling
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
General disorders
Fatigue
|
4.6%
3/65 • Number of events 8 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
General disorders
Pyrexia
|
16.9%
11/65 • Number of events 17 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Pneumonia
|
13.8%
9/65 • Number of events 14 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
5/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Infections and infestations
Urinary tract infection
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Alanine aminotransferase increased
|
16.9%
11/65 • Number of events 18 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
18.5%
12/65 • Number of events 15 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Blood urea increased
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Blood uric acid increased
|
4.6%
3/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
C-reactive protein increased
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
5/65 • Number of events 6 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Lymphocyte count decreased
|
13.8%
9/65 • Number of events 16 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Neutrophil count decreased
|
33.8%
22/65 • Number of events 41 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Neutrophil count increased
|
4.6%
3/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Platelet count decreased
|
30.8%
20/65 • Number of events 44 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
SARS-CoV-2 test positive
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
Weight decreased
|
6.2%
4/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Investigations
White blood cell count decreased
|
29.2%
19/65 • Number of events 30 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.8%
7/65 • Number of events 7 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.6%
3/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
13.8%
9/65 • Number of events 14 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.5%
12/65 • Number of events 14 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
4/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.2%
4/65 • Number of events 5 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.3%
8/65 • Number of events 12 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
4/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
5/65 • Number of events 12 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
3.1%
2/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
3/65 • Number of events 6 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Nervous system disorders
Headache
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Nervous system disorders
Hypoaesthesia
|
4.6%
3/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Psychiatric disorders
Insomnia
|
3.1%
2/65 • Number of events 2 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Renal and urinary disorders
Renal impairment
|
4.6%
3/65 • Number of events 4 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
6/65 • Number of events 7 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.6%
3/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
3/65 • Number of events 3 • From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeOne 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. BeOne 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