Phase 2
Completed N=249
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
Source: ClinicalTrials.gov NCT03419897 ↗Enrolled (actual)
249
Serious AEs
37.8%
Results posted
Jul 2023
Primary outcomePrimary: Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC) — 12.9 Percentage of participants — p=0.0001
Summary
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC) |
12.9 | 0.0001 sig |
| SECONDARY ORR Assessed by Investigator |
14.5 | — |
| SECONDARY Duration of Response (DOR) Assessed by IRC |
NA | — |
| SECONDARY DOR Event-Free Rate Assessed by IRC |
76.9; 65.9 | — |
| SECONDARY DOR Assessed by Investigator |
21.4 | — |
| SECONDARY DOR Event-Free Rate Assessed by Investigator |
68.1; 47.4 | — |
| SECONDARY Progression-free Survival (PFS) Assessed by IRC |
2.7 | — |
| SECONDARY PFS Assessed by Investigator |
2.8 | — |
| SECONDARY Overall Survival (OS) |
13.2 | — |
| SECONDARY Disease Control Rate (DCR) Assessed by IRC |
53.0 | — |
| SECONDARY DCR Assessed by Investigator |
59.0 | — |
| SECONDARY Clinical Benefit Rate (CBR) Assessed by IRC |
22.5 | — |
| SECONDARY CBR Assessed by Investigator |
30.9 | — |
| SECONDARY European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS) |
75.2; 2.4; 4.7 | — |
| SECONDARY European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status |
71.8; -0.1; 1.1 | — |
| SECONDARY EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores |
13.6; 1.4; 0.1 | — |
| SECONDARY Number of Participants With Adverse Events |
236; 94 | — |
Eligibility Criteria
Key Inclusion Criteria
- Histologically confirmed HCC
- Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
- Has received at least 1 line of systemic therapy for unresectable HCC
- Has at least 1 measurable lesion as defined per RECIST v1.1
- Child-Pugh score A
- Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Key Exclusion Criteria
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapies targeting PD-1 or PD-L1
- Has known brain or leptomeningeal metastasis
- Tumor thrombus involving main trunk of portal vein or inferior vena cava
- Loco-regional therapy to the liver within 4 weeks before enrollment
- Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
- Has received:
- Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
- Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03419897). 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. Informational only — not medical advice.