Study of Zanubrutinib (BGB-3111) in Patients With Marginal Zone Lymphoma

This is a Phase 2, open-label study of zanubrutinib in approximately 65 patients with R/R
MZL. The study will evaluate efficacy, as measured by overall response rate, safety and
tolerability.

Inclusion Criteria:

1. Age 18 years or older

2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal
subtypes

3. Previously received one or more lines of therapy including at least one CD20-directed
regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to
achieve at least PR or documented PD after, the most recent systemic treatment

4. Current need for systemic therapy for MZL

5. Measurable disease by CT or MRI

6. ECOG of 0-2

7. Life expectancy ≥ 6 months

8. Adequate bone marrow function

9. Adequate organ function

10. Male and female patients must use highly effective methods of contraception

Exclusion Criteria:

1. Known transformation to aggressive lymphoma, eg, large cell lymphoma.

2. Clinically significant cardiovascular disease

3. Prior malignancy within the past 2 years, except for curatively treated basal or
squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix
or breast, or localized Gleason score 6 prostate cancer

4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand
disease, or history of spontaneous bleeding requiring blood transfusion or other
medical intervention

5. History of stroke or intracranial hemorrhage

6. Severe or debilitating pulmonary disease

7. Active fungal, bacterial and/or viral infection requiring systemic therapy

8. Known central nervous system involvement by lymphoma

9. Known infection with HIV, or serologic status reflecting active viral hepatitis B
(HBV) or viral hepatitis C (HCV) infection

10. Major surgery within 4 weeks of the first dose of study drug

11. Prior treatment with a BTK inhibitor

12. Pregnant or lactating women

13. Requires ongoing treatment with a strong CYP3A inhibitor or inducer

14. Concurrent participation in another therapeutic clinical trial