18 and older, any sex, with Relapsed/Refractory Follicular Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) by Independent Central Review (ICR) AssessmentPrimary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
Group
Value
95% CI
Obinutuzumab
45.8
34.0 – 58.0
Zanubrutinib + Obinutuzumab
68.3
60.0 – 75.7
Overall Response Rate (ORR) as Assessed by the InvestigatorSecondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
Group
Value
95% CI
Obinutuzumab
41.7
30.2 – 53.9
Zanubrutinib + Obinutuzumab
66.2
57.9 – 73.8
Duration of Response (DOR) as Determined by Investigator AssessmentSecondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
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. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Obinutuzumab
9.2
3.8 – NA
Zanubrutinib + Obinutuzumab
30.6
24.7 – NA
DOR as Determined by ICRSecondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
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. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Obinutuzumab
NA
9.0 – NA
Zanubrutinib + Obinutuzumab
NA
24.7 – NA
Progression-free Survival (PFS)Secondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.
ICR
Group
Value
95% CI
Obinutuzumab
11.2
6.5 – 15.7
Zanubrutinib + Obinutuzumab
27.4
16.1 – NA
Investigator
Group
Value
95% CI
Obinutuzumab
5.8
3.7 – 8.2
Zanubrutinib + Obinutuzumab
22.2
11.3 – NA
Overall Survival (OS)Secondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
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.
Group
Value
95% CI
Obinutuzumab
NA
26.8 – NA
Zanubrutinib + Obinutuzumab
NA
31.4 – NA
Complete Response RateSecondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy.
ICR
Group
Value
95% CI
Obinutuzumab
19.4
11.1 – 30.5
Zanubrutinib + Obinutuzumab
37.2
29.4 – 45.7
Investigator
Group
Value
95% CI
Obinutuzumab
19.4
11.1 – 30.5
Zanubrutinib + Obinutuzumab
29.0
21.7 – 37.1
Time to Response (TTR)Secondary· From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation.
ICR
Group
Value
95% CI
Obinutuzumab
2.83
2.5 – 6.5
Zanubrutinib + Obinutuzumab
2.83
2.0 – 14.0
Investigator
Group
Value
95% CI
Obinutuzumab
2.79
2.5 – 16.6
Zanubrutinib + Obinutuzumab
2.79
2.0 – 16.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom ScoresSecondary· Baseline, Week 12, and Week 24
The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom sco
Global Health Status/QOL: Week 12
Group
Value
95% CI
Obinutuzumab
-2.222
± 16.9856
Zanubrutinib + Obinutuzumab
4.023
± 16.2440
Global Health Status/QOL: Week 24
Group
Value
95% CI
Obinutuzumab
4.955
± 15.1458
Zanubrutinib + Obinutuzumab
2.577
± 17.3623
Physical Function: Week 12
Group
Value
95% CI
Obinutuzumab
-1.449
± 13.2526
Zanubrutinib + Obinutuzumab
0.361
± 13.8192
Physical Function: Week 24
Group
Value
95% CI
Obinutuzumab
0.270
± 10.2553
Zanubrutinib + Obinutuzumab
0.412
± 11.4186
Role Function: Week 12
Group
Value
95% CI
Obinutuzumab
1.812
± 25.6347
Zanubrutinib + Obinutuzumab
2.730
± 22.9412
Role Function: Week 24
Group
Value
95% CI
Obinutuzumab
-0.901
± 21.1352
Zanubrutinib + Obinutuzumab
3.093
± 17.4022
Fatigue: Week 12
Group
Value
95% CI
Obinutuzumab
2.657
± 19.3424
Zanubrutinib + Obinutuzumab
-1.947
± 19.5647
Fatigue: Week 24
Group
Value
95% CI
Obinutuzumab
-0.150
± 15.0722
Zanubrutinib + Obinutuzumab
-2.291
± 18.4911
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)Secondary· Baseline, Week 12, and Week 24
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.' A higher score indicates better health outcomes.
Week 12
Group
Value
95% CI
Obinutuzumab
-0.3
± 14.96
Zanubrutinib + Obinutuzumab
2.4
± 16.71
Week 24
Group
Value
95% CI
Obinutuzumab
2.0
± 14.17
Zanubrutinib + Obinutuzumab
3.1
± 15.95
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Secondary· From first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
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 is linked to the study drug.
At Least One TEAE
Group
Value
95% CI
Obinutuzumab
65
Zanubrutinib + Obinutuzumab
137
At Least One SAE
Group
Value
95% CI
Obinutuzumab
22
Zanubrutinib + Obinutuzumab
75
Area Under the Curve (AUCss) of Zanubrutinib at Steady StateSecondary· Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
Group
Value
95% CI
Zanubrutinib + Obinutuzumab
2203.619021
± 1045.430371
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Obinutuzumab Monotherapy
Serious: 22/71 (31%)
Deaths: 33/72
Zanubrutinib Plus Obinutuzumab
Serious: 75/143 (52%)
Deaths: 51/145
Crossover Treatment
Serious: 20/36 (56%)
Deaths: 16/36
Serious adverse events (119 terms)
Reaction
System
Obinutuzumab Monotherapy
Zanubrutinib Plus Obinutuz…
Crossover Treatment
Pneumonia
Infections and infestations
—
—
—
COVID-19
Infections and infestations
—
—
—
COVID-19 pneumonia
Infections and infestations
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
Lower respiratory tract infection
Infections and infestations
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
Death
General disorders
—
—
—
Multiple organ dysfunction syndrome
General disorders
—
—
—
Pyrexia
General disorders
—
—
—
Anal abscess
Infections and infestations
—
—
—
Septic shock
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR
· Phase 2
· not yet recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel
· Phase 1
· recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C
· Phase 3
· not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
· not yet recruiting
Other BeiGene trials
Trials by the same sponsor.
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· recruiting
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· active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-
· Phase 1
· active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
· Phase 1
· completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 18 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03332017.