Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC

Inclusion Criteria:

- 1. Histologically confirmed diagnosis of HCC

2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or
progressing after loco-regional therapy and not amenable to a curative treatment
approach

3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in
the safety run-in substudy [Japan only])

4. Measurable disease

5. Child-Pugh score A

6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1

7. Adequate organ function

Exclusion Criteria:

- 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
histology

2. Tumor thrombus involving main trunk of portal vein or inferior vena cava

3. Loco-regional therapy to the liver within 28 days before randomization

4. Clinical evidence of portal hypertension with bleeding esophageal or gastric
varices at Screening, or within 6 months before randomization

5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring
therapeutic international normalized ratio monitoring (eg, warfarin or similar agents)
at Screening, or within 6 months before randomization/enrollment

6. Presence at Screening of active immune deficiency or autoimmune disease and/or
prior history of any immune deficiency or autoimmune disease that may relapse

7. Patient with any condition requiring systemic treatment with either corticosteroids
(> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication
within 14 days before randomization

8. History of interstitial lung disease or non-infectious pneumonitis, unless induced
by radiation therapy

9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450
msec at Screening