Shanghai, China, July 2, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world.

Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and 1.6 million deaths per year [2]. According to the latest report by National Cancer Center (NCC) of China, the incidence and mortality of CRC in China ranked 2nd and 4th among all cancers with 517,000 new cases and 240,000 deaths in 2022 [1].

CRC often spreads before the initial tumour is detected. Based on molecular phenotype, mCRC is generally divided into two groups, dMMR/MSI-H and pMMR/MSS, with the latter accounting for around 95% of mCRC [3,4]. The standard of care for mCRC involves the combination of vascular endothelial growth factor (VEGF) inhibitor, such as bevacizumab, and systemic chemotherapy [5-7]. However, sustained efficacy and prognosis remain to be improved. Several PD-1 inhibitors were shown to confer significant survival benefits for advanced CRC patients with dMMR/MSI-H [8,9]. However, pMMR/MSS mCRC, which accounts for a much higher proportion of mCRC, are considered “immune-cold tumours” characterised by low response rate to immunotherapy. To date, there has been no globally approved immunotherapy for the first-line treatment of pMMR/MSS mCRC, indicating a significant unmet medical need for this patient population.

The company is continuing to explore immuno-oncology therapy for mCRC, with the goal of delivering highly effective treatment for a broad population of patients. ASTRUM-015 trial is a phase 2/3 study of HANSIZHUANG (serplulimab) plus bevacizumab and chemotherapy as first-line treatment for patients with mCRC. The results of the phase 2 stage of ASTRUM-015 were presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) and 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Recently, the results were also published online in MED, demonstrating the global recognition of serplulimab by the community. In conclusion, the addition of serplulimab to bevacizumab and chemotherapy conferred a numerically longer median progression-free survival, along with a manageable safety profile for mCRC patients as a whole, and those with MSS mCRC. These results support serplulimab plus bevacizumab and chemotherapy as a promising first-line treatment option for mCRC that warrants further investigation.

Moving forward, Henlius will actively promote the clinical progress of the Phase 3 stage of ASTRUM-015. With the accelerated progress, HANSIZHUANG (serplulimab) 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.

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