Recently, Liver Cancer (IF 12.43), a prestigious journal in hepatology, published the phase 2 study of HANSIZHUANG (serplulimab) plus HANBEITAI (bevacizumab, HLX04) in patients with advanced hepatocellular carcinoma (HCC) https://www.karger.com/Article/Abstract/526638 . Serplulimab plus HLX04 demonstrated a manageable safety profile and favorable antitumor activity in patients with previously treated advanced HCC.
This open-label, multi-centre phase 2 study aimed to assess the safety, tolerability, and efficacy of serplulimab in combination with HLX04 for patients with advanced HCC. Given the data maturity, this publication only discloses results from patients treated with serplulimab plus HLX04 who had received prior systemic therapy (i.e., groups A and B). Patients received intravenous infusions of serplulimab 3 mg/kg and intravenous infusions of HLX04 at either 5 mg/kg (group A) or 10 mg/kg (group B) every 2 weeks. The primary endpoints were safety and tolerability. Secondary endpoints included objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and duration of response (DoR), among others.
As of April 8, 2021, results from both groups (group A, n=20; group B, n=21) demonstrated that serplulimab plus HLX04 was safe and well-tolerated. As assessed by an independent radiological review committee (IRRC), the ORR was 30.0% (95% CI, 11.9–54.3) in group A and 14.3% (95% CI, 3.0–36.3) in group B. Median PFS was 2.2 months (95% CI, 1.4–5.5) in group A and 4.1 months (95% CI, 1.5–NE) in group B. The safety profile for serplulimab plus HLX04 in this study were consistent with the safety profiles of the two drug classes and with that of atezolizumab plus bevacizumab in previously untreated patients with advanced HCC. The efficacy outcomes for serplulimab plus HLX04 were similar or better compared with other anti-PD-(L)1 therapies. These results provide evidence for the use of anti-PD-1 monoclonal antibody (mAb) in combination with anti-angiogenic agents in the second- or later-line treatment of HCC in clinical practice. An investigational new drug application for a phase 2 trial of serplulimab in combination with HLX04 and HLX07 (innovative anti-EGFR mAb) for the first-line treatment of unresectable or metastatic HCC has been approved by the National Medical Products Administration (NMPA).
HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. It has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company such as tumour-specific target, angiogenesis target, immunotherapeutic target, etc. and chemotherapy drugs to conduct immune combination therapies. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications, such as lung cancer, HCC, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. Up to date, more than 3,100 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.
As Henlius moves forward, it will continue to conduct clinical studies on more innovative products, proactively exploring immuno-oncology combination therapy, bispecific antibodies and antibody-drug conjugates (ADC), with the aim of bringing affordable and high-quality innovative biologics to patients around the world.
About Liver Cancer
Liver cancer has a very high prevalence among cancers in general and is one of the most common causes of death worldwide. Based on these facts, the journal Liver Cancer serves the growing need to better understand the causes, mechanisms, and therapy of the malignancy. It provides the international community of researchers and clinicians with a platform for their research results, focusing on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy, of the disease. Liver Cancer publishes clinical and translational research related to the field of liver cancer in both humans and experimental models in the form of original and review articles.
Ren Z, et al. Phase 2 Study of the PD-1 Inhibitor Serplulimab Plus the Bevacizumab Biosimilar HLX04 in Patients with Previously Treated Advanced Hepatocellular Carcinoma. Liver Cancer 2022. Advance online publication. doi: 10.1159/000526638