Abstract 201P
Background
Hepatocellular carcinoma (HCC) accounts for around 90% of liver cancer cases, and there are still significant therapeutic challenges. This study aimed to assess the safety and preliminary efficacy of serplulimab, a novel programmed cell death-1 inhibitor, with or without the bevacizumab biosimilar HLX04 in patients with advanced HCC.
Methods
Patients with advanced HCC who failed prior systemic therapy received serplulimab 3 mg/kg plus HLX04 5 mg/kg (group A), serplulimab 3 mg/kg plus HLX04 10 mg/kg (group B), or serplulimab 3 mg/kg monotherapy (group C). Patients with previously untreated advanced HCC were enrolled in group D and given serplulimab 3 mg/kg plus HLX04 10 mg/kg. All treatments were administered intravenously every 2 weeks. The primary endpoint was safety.
Results
This open-label, multicentre phase 2 study was conducted in China; 28 hospitals enrolled patients. Results of group A and B have been previously published; here we present results of group C and D. As of 7 February 2023, 21 and 61 patients were enrolled in group C and D. The median follow-up duration was 26.0 and 25.5 months, respectively. 10 (47.6%) patients in group C and 29 (47.5%) in group D reported grade ≥3 treatment-emergent adverse events. 1 (4.8%) patient in group C died from treatment-related hepatic failure; 1 (1.6%) in group D died from treatment-related hepatic failure and disease progression. As assessed by an independent radiological review committee (IRRC) per RECIST v1.1, the objective response rate was 4.8% (95% confidence interval [CI] 0.1–23.8) in group C and 27.9% (95% CI 17.1–40.8) in group D. IRRC-assessed median progression-free survival was 1.8 months (95% CI 1.4–2.8) and 7.3 months (95% CI 2.8–11.0) in group C and D, respectively. Median overall survival was 16.0 months (95% CI 3.6–not evaluable [NE]) in group C and 19.1 months (95% CI 14.3–NE) in group D.
Conclusions
In the first-line and subsequent-line settings, serplulimab plus HLX04 and serplulimab monotherapy, respectively, showed a manageable safety profile together with encouraging efficacy in patients with advanced HCC.
Clinical trial identification
NCT03973112 (released on 4 June 2019).
Editorial acknowledgement
Editorial assistance was provided by Shiqi Zhong, Zhi Hao Kwok, and Chen Hu of Shanghai Henlius Biotech, Inc.
Legal entity responsible for the study
Shanghai Henlius Biotech, Inc.
Funding
Shanghai Henlius Biotech, Inc.
Disclosure
X. Hou, Q. Wang, J. Zhu: Financial Interests, Personal, Full or part-time Employment: Shanghai Henlius Biotech, Inc. All other authors have declared no conflicts of interest.
Resources from the same session
183P - Final analysis of phase II clinical study evaluating the safety and effectiveness of neoadjuvant S-1 + oxaliplatin combination therapy for older patients with locally advanced gastric cancer
Presenter: Eiji Oki
Session: Poster Display
Resources:
Abstract
184P - Neutropenia as a predictive and prognostic factor in nanoliposomal-irinotecan/fluorouracil/leucovorin therapy for pancreatic cancer: Findings from the NAPOLEON-2 study (NN-2301)
Presenter: Yuki Sonoda
Session: Poster Display
Resources:
Abstract
185P - Disease etiology impact on outcomes of hepatocellular carcinoma patients treated with atezolizumab plus bevacizumab: A real-world, multicenter study
Presenter: Silvia Foti
Session: Poster Display
Resources:
Abstract
186P - Efficacy and safety of fruquintinib with nab-paclitaxel in advanced G/GEJ cancer after exposure to immune checkpoint inhibitors: A single-center prospective clinical trial
Presenter: Xiaoting Ma
Session: Poster Display
Resources:
Abstract
187P - Neoadjuvant cadonilimab (PD-1/CTLA-4 bispecific antibody) plus transhepatic arterial infusion chemotherapy (HAIC) for resectable multinodular CNLC Ib/IIa hepatocellular carcinoma (Car-Hero)
Presenter: Yongguang Wei
Session: Poster Display
Resources:
Abstract
188P - Impact of metformin, statin, aspirin and insulin on the prognosis of unresectable HCC patients receiving first-line lenvatinib or atezolizumab plus bevacizumab
Presenter: Margherita Rimini
Session: Poster Display
Resources:
Abstract
189P - Safety run-in results from LEAP-014: First-line lenvatinib (len) plus pembrolizumab (pembro) and chemotherapy (chemo) for metastatic esophageal squamous cell carcinoma (ESCC)
Presenter: Shun Yamamoto
Session: Poster Display
Resources:
Abstract
190P - Perioperative camrelizumab combined with chemotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma: A single-arm, single-center, phase II clinical trial
Presenter: Jiaxing He
Session: Poster Display
Resources:
Abstract
191P - Predictive value of CXCR6 expression in gastric cancer survival and immune modulation
Presenter: Song-Hee han
Session: Poster Display
Resources:
Abstract
192P - Antiangiogenesis-related adverse events (ARAE) to predict efficacy in patients with advanced gastric cancer (AGC) treated with apatinib + chemotherapy: Results from two prospective studies
Presenter: Rongbo Lin
Session: Poster Display
Resources:
Abstract