Phase 2
N=68
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Marginal Zone Lymphoma · MZL
Bottom Line
View on ClinicalTrials.gov: NCT03846427 ↗Enrolled (actual)
68
Serious AEs
44.1%
Results posted
Mar 2022
Primary outcome: Primary: Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment — 68.2 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zanubrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment |
68.2 | <0.0001 sig |
| SECONDARY ORR by Investigator Assessment |
75.8 | — |
| SECONDARY ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT) |
69.5 | — |
| SECONDARY Progression-free Survival (PFS) by Investigator Assessment |
NA | — |
| SECONDARY PFS Event-Free Rate by Investigator Assessment |
57.9 | — |
| SECONDARY PFS by IRC Assessment |
NA | — |
| SECONDARY PFS Event-Free Rate by IRC Assessment |
70.9 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY OS Event-Free Rate |
85.9 | — |
| SECONDARY Duration of Response (DOR) by Investigator Assessment |
NA | — |
| SECONDARY DOR Event-Free Rate by Investigator Assessment |
60.8 | — |
| SECONDARY DOR by IRC Assessment |
NA | — |
| SECONDARY DOR Event-Free Rate by IRC Assessment |
72.9 | — |
| SECONDARY Time to Treatment Failure (TTF) |
27.8 | — |
| SECONDARY TTF Event-Free Rate |
53.0 | — |
| SECONDARY Time to Next Line of Therapy |
NA | — |
| SECONDARY Time to Next Line of Therapy Event-Free Rate |
74.5 | — |
| SECONDARY Time to Response (TTR) by Investigator Assessment |
2.79 | — |
| SECONDARY TTR by IRC Assessment |
2.79 | — |
| SECONDARY Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS) |
1.0; 2.2; 0.2; 2.8; 5.6; 5.8 | — |
| SECONDARY Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status |
7.471; 7.823; 5.382; 7.143; 10.677; 9.286 | — |
| SECONDARY Number of Participants With Adverse Events |
68; 30 | — |
| SECONDARY Area Under the Curve From Time 0 to 6 Hours (AUC0-6) |
868.0 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Zanubrutinib |
215.3 | — |
| SECONDARY Maximum Observed Concentration (Cmax) |
315.5 | — |
| SECONDARY Elimination Half Life (t1/2) |
1.2 | — |
Summary
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Eligibility Criteria
Key Inclusion Criteria
- Age 18 years or older
- Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
- Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment
- Current need for systemic therapy for MZL
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) of 0-2
- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Adequate organ function
- Male and female participants must use highly effective methods of contraception
Key Exclusion Criteria
- Known transformation to aggressive lymphoma, eg, large cell lymphoma
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage
- Severe or debilitating pulmonary disease
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Known central nervous system involvement by lymphoma
- Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
- Major surgery within 4 weeks of the first dose of study drug
- Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
- Pregnant or lactating women
- Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
- Concurrent participation in another therapeutic clinical trial
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03846427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.