Recently, the updated results and biomarker analysis of ASTRUM-005, Henlius’ international multi-centre phase 3 study of its innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab, trade name: Hetronifly^® in Europe) as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) were published in Cancer Communications (IF 20.1), with Professor Ying Cheng from Jilin Province Cancer Hospital as the leading principal investigator of this study. The results of ASTRUM-005 were first presented at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and published in the Journal of the American Medical Association (JAMA), one of the top four medical journals in the world, in September 2022. At the recent 2025 ASCO Annual Meeting, the ASTRUM-005 study released 42.4 months of median follow-up data, disclosing a four-year overall survival (OS) rate of 21.9%. The updated results and exploratory biomarker analysis from ASTRUM-005 up to June 13, 2022, published in Cancer Communications this time, were first presented at the 2022 European Society for Medical Oncology Asia (ESMO Asia) Congress and the American Association for Cancer Research (AACR) Annual Meeting 2024, respectively.

Lung cancer is one of the most common malignancies worldwide. Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage. ASTRUM-005 is a randomised, double-blind, international, multi-centre, phase 3 study aimed to compare the efficacy and safety of serplulimab, versus placebo in combination with chemotherapy in previously untreated ES-SCLC patients. Based on the pivotal clinical trial ASTRUM-005, HANSIZHUANG has been approved for the treatment of ES-SCLC in over 30 countries and regions, including China, Europe and Southeast Asia. HANSIZHUANG is the world’s first anti-PD-1 mAb for the first-line treatment of SCLC.

In ASTRUM-005, 585 patients with previously untreated ES-SCLC were randomised in a 2:1 ratio (serplulimab group, n = 389; placebo group, n = 196) to receive 4.5 mg/kg serplulimab or placebo intravenously every 3 weeks. All patients also received carboplatin and etoposide for up to 4 cycles. The primary endpoint was overall survival (OS). In addition, the associations between efficacy outcomes, including objective response rate (ORR), OS, and progression-free survival (PFS), and gene mutation status or differentially expressed proteins (DEPs) were examined with regression analysis in the exploratory biomarker analysis. Furthermore, the prognostic value of hematological parameters was evaluated.

By the data cutoff of June 13, 2022, in the intent-to-treat population, the median OS was 15.8 months in the serplulimab group versus 11.1 months in the placebo group (hazard ratio, 0.62; 95% confidence interval, 0.50-0.76; descriptive P < 0.001). We identified 181 DEPs by comparing the serum proteomes of responders versus non-responders in the serplulimab group and constructed a 15-protein signature. In the serplulimab group, patients with a higher 15-protein signature score were associated with significantly longer OS and PFS. Also, patients harboring tumor-suppressor retinoblastoma-1 (RB1) mutations or mutations in Notch pathway members showed improved ORR, OS, or PFS compared with their wild-type counterparts. Baseline neutrophil-to-lymphocyte ratio (NLR) and lactate dehydrogenase (LDH) level were independent prognosticators of patients with ES-SCLC.

Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). In the future, Henlius will continue to focus on clinical needs, persist in innovative exploration, help patients improve survival benefits, and bring more high-quality, affordable treatment options to patients worldwide.