Abstract
ObjectiveThis study aims to assess the efficacy and safety of penpulimab (a humanized anti-PD-1 IgG1 antibody) with anlotinib in the first-line treatment of Chinese patients with uHCC.MethodsIn this open-label multicenter phase Ib/II trial, patients with histologically or cytologically confirmed uHCC, without previous systemic treatment, aged 18–75 years old, classified as BCLC stage B (not amenable for locoregional therapy) or C, with Child–Pugh score ≤7 and ECOG performance status ≤1 were enrolled. Patients received penpulimab [200 mg intravenous (i.v.) Q3W] and oral anlotinib (8 mg/day, 2 weeks on/1 week off). The primary endpoint was objective response rate (ORR). Secondary endpoints included safety, disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DoR), and overall survival (OS). This trial is registered with ClinicalTrials.gov (NCT04172571).ResultsAt the data cutoff (December 30, 2020), 31 eligible patients had been enrolled and treated with a median follow-up of 14.7 months (range, 1.4–22.1). The ORR was 31.0% (95% CI, 15.3–50.8%), and the DCR was 82.8% (95% CI, 64.2–94.2%). The median PFS and TTP for 31 patients were 8.8 months (95% CI, 4.0–12.3) and 8.8 months (95% CI, 4.0–12.9) respectively. The median OS was not reached; the 12-month OS rate was 69.0% (95% CI, 48.9–82.5%). Only 19.4% (6/31) of patients had grade 3/4 treatment-related adverse events (TRAEs).ConclusionPenpulimab plus anlotinib showed promising anti-tumor activity and a favorable safety profile as first-line treatment of patients with uHCC.
Highlights
Primary liver cancer is the fourth leading cause of death from cancer worldwide with a 5-year survival rate of only 12–20% [1,2,3]
This study aims to assess the efficacy and safety of penpulimab with anlotinib in the first-line treatment of Chinese patients with uHCC
The median progression-free survival (PFS) and time to progression (TTP) for 31 patients were 8.8 months and 8.8 months respectively
Summary
Primary liver cancer is the fourth leading cause of death from cancer worldwide with a 5-year survival rate of only 12–20% [1,2,3]. Hepatocellular carcinoma (HCC) is the major histological subtype, accounting for approximately 80% of liver cancer. HBV infection is one of the main risk factor of HCC, and in China the HBV carrier rate was 7.18% varying from the low rate of 0.1–2.0% in the United States and Western Europe. In excess of 50% of newly diagnosed cases and deaths from HCC have occurred in China [2, 3], approximately 70–80% of whom were related to HBV infection, quite distinct from Western patients [4, 5]. Patients with HCC are often diagnosed at advanced stages, not amenable to surgery or locoregional treatment. Previously demonstrated to prolong survival by a few months in patients with HCC [6,7,8], were the only two drugs approved by the Food and Drug Administration (FDA) until 2018 for first-line treatment of HCC
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