Recently, the latest data from Henlius' Phase II clinical study (NCT03973112) of serplulimab (HANSIZHUANG) in combination with HLX04 (bevacizumab) for the treatment of advanced hepatocellular carcinoma (HCC) were published in Cancer Immunology, Immunotherapy. The study demonstrated that the combination therapy of serplulimab with HLX04 showed a manageable safety profile and promising anti-tumor efficacy in previously untreated patients with advanced HCC.

The NCT03973112 study is an open-label, multicenter, single-arm, phase 2 clinical trial aimed to evaluate the safety and efficacy of serplulimab as monotherapy or in combination with HLX04 in patients with advanced hepatocellular carcinoma (HCC). Data from this study were first published in the renowned hepatology journal Liver Cancer in 2022, presenting the results of the combination therapy in patients who had received prior systemic therapy. Patients received intravenous infusions of serplulimab at 3 mg/kg every two weeks in combination with different doses of HLX04 (5 mg/kg or 10 mg/kg). The study results demonstrated that the combination of serplulimab and HANBEITAI showed a manageable safety profile and favorable anti-tumor activity in patients with previously treated advanced HCC.

The latest data published in Cancer Immunology, Immunotherapy focus on the subgroup of patients (n=61) who had not previously received systemic treatment. These patients received intravenous infusions of serplulimab (3 mg/kg) combined with HLX04 (10 mg/kg) every two weeks. The primary endpoint was safety, while secondary endpoints included objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and duration of response (DoR), among others. As of February 7, 2023, the combination therapy of serplulimab and HLX04 was well tolerated in patients with aHCC in the first-line setting. In the efficacy evaluable set (EES) of patients (n=58), the ORR was 29.3% (95% CI: 18.1–42.7) as assessed by an independent radiological review committee (IRRC) per RECIST v1.1. The median PFS was 7.3 months (95% CI: 2.8–11.0), and the median DoR was 12.7 months (95% CI: 4.5–not evaluable [NE]). Notably, among the 17 patients who achieved a response, 12 (70.6%) had a DoR of at least 6 months.

The study results showed that the safety profile of serplulimab, HLX04, and their combination therapy in patients with previously untreated advanced HCC was consistent with those reported for monotherapy with anti-PD-1 inhibitors, bevacizumab, and the combination of atezolizumab plus bevacizumab. Moreover, compared to other PD-(L)1 inhibitors, the combination therapy of serplulimab and HLX04 conferred similar or greater survival benefit in the Chinese population. These findings may provide a basis for the clinical application of serplulimab in combination with anti-angiogenic agents as a first-line treatment for HCC.

HANSIZHUANG, the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC developed by Henlius, has been approved in China and several Southeast Asian countries, benefiting over 90,000 patients to date. Focusing on gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. This includes extensive clinical development in high-incidence cancers such as colorectal cancer, gastric cancer, liver cancer, and esophageal cancer. In September 2023, the combination of HANSIZHUANG and chemotherapy for the first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) was approved by the National Medical Products Administration (NMPA), offering a new immunotherapy option for patients with ESCC. Additionally, HANSIZHUANG has led the way with a phase 3 clinical study on neoadjuvant/adjuvant therapies for gastric cancer, striving to benefit gastric cancer patients from the early line of immunotherapy. Furthermore, the international multicenter clinical study (ASTRUM-015) of HANSIZHUANG in combination with bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC) has launched its phase 3 stage and completed the first patient dosing in China, Japan, and Indonesia. With the accelerated progress, HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for previously untreated mCRC and fill the clinical gap in first-line immunotherapy in these patients.

Looking forward, Henlius will actively improve efficiency through innovations, focusing on unmet medical needs to bring more high-quality and affordable therapies to patients worldwide.