Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital.

Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for the treatment of sqNSCLC has been approved by the National Medical Products Administration (NMPA) based on the results of ASTRUM-004. Furthermore, HANSIZHUANG has been recommended as Grade I by the 2023 CSCO Guidelines for Non-Small Cell Lung Cancer for the first-line treatment of advanced sqNSCLC due to its outstanding clinical effectiveness and survival advantages for sqNSCLC patients.

Lung cancer is one of the most common cancers in the world, and it is the malignant tumour with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 828,000 new cases of lung cancer, with a total death toll of 657,000 [1], in which NSCLC accounts for about 80% - 85% of all lung cancers [2], and about 50% of NSCLC patients are in locally advanced stage that is not suitable for surgical resection or have metastasis at the time of diagnosis. Treatment of advanced sqNSCLC, making up about 30% of the advanced NSCLC, is given first place to a platinum-based doublet chemotherapy, which has limited efficacy, and the median survival time is quite short, many of which are less than 1 year. Therefore, there are huge unmet medical needs. In recent years, immune checkpoint inhibitors have made breakthroughs in NSCLC treatment, especially, the anti-PD-1 mAb combined with carboplatin and albumin-bound paclitaxel which has been recommended by domestic and international authoritative guidelines for the treatment of advanced or metastatic sqNSCLC, pushing forward the treatment of the advanced NSCLC into the era of immunotherapy.

ASTRUM-004 is a randomized, double-blind, international multicentre phase 3 study to compare the clinical efficacy and safety of serplulimab plus chemotherapy versus chemotherapy in patients with locally advanced or metastatic sqNSCLC who have not previously received systemic treatment. As of January 31, 2023, a total of 537 patients were randomized 2:1 to receive intravenous serplulimab 4.5 mg/kg or placebo (up to 35 cycles) in combination with chemotherapy (carboplatin and nab-paclitaxel, 4-6 cycles) in 3-week cycles. Updated analysis of progression-free survival (PFS) showed that with a median follow-up of 16.9 months, the PFS benefit of serplulimab-chemotherapy vs. placebo-chemotherapy was maintained (IRRC-assessed, median, 8.3 vs. 5.7 months; hazard ratio [HR] 0.53, 95% CI 0.42-0.67). The HR for PFS consistently favoured serplulimab-chemotherapy group across the prespecified subgroups. Final analysis of overall survival (OS) demonstrated that with a median follow-up of 31.1 months, OS was significantly prolonged with the addition of serplulimab (median, 22.7 vs. 18.2 months; HR 0.73, 95% CI 0.58-0.93; p=0.010, crossing the significance boundary of 0.046). By the time of the final analysis, 97 (54.2%) patients in the placebo-chemotherapy group had crossed over to serplulimab monotherapy. The median OS in the placebo-chemotherapy group adjusted by the two-stage model was 11.5 months (95% CI 9.6–13.5), resulting in an adjusted HR of 0.49 (95% CI 0.37–0.64). The safety profile of serplulimab plus chemotherapy was manageable. In conclusion, serplulimab plus chemotherapy could be a promising treatment option for this patient population.

HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, sqNSCLC, extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), benefiting more than 51,000 patients. In December 2023, HANSIZHUANG was approved in Indonesia for the treatment of ES-SCLC. The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. 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, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. To date, more than 3,600 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.

As for the first-line lung cancer treatment, in addition to ASTRUM-004, a pivotal phase 3 clinical study of HANSIZHUANG for the first-line treatment of ES-SCLC, ASTRUM-005, has been published in the Journal of the American Medical Association (JAMA), one of the top four medical journals, and became the world's first clinical study on SCLC immunotherapy in JAMA. In the field of gastrointestinal cancer, the results of 2 pivotal trials of HANSIZHUANG in MSI-H solid tumours and ESCC were published in the British Journal of Cancer and Nature Medicine, respectively. Furthermore, HANSIZHUANG was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

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.

https://mp.weixin.qq.com/s/Ql09namMuFrnHJFUt2N1_A