Shanghai, China, May 18th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the phase 3 clinical study ASTRUM-007 of HANSIZHUANG (serplulimab) independently developed by the company in combination with chemotherapy as a first-line treatment for patients with locally advanced/metastatic esophageal squamous cell carcinoma (ESCC), met the co-primary endpoints of progression-free survival (PFS) and overall survival (OS) in a planned interim analysis, evaluated by the Independent Data Monitoring Committee (IDMC).
ASTRUM-007 is a randomized, double-blind, multi-center phase 3 clinical study among patients with locally advanced/metastatic ESCC, aiming to compare the efficacy and safety of HANSIZHUANG or placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced/metastatic ESCC. The principal investigator of ASTRUM-007 is Professor Jing Huang from Cancer Hospital Chinese Academy of Medical Sciences. Based on the results of pre-defined interim analysis conducted by IDMC, HANSIZHUANG in combination with chemotherapy showed a significant improvement in PFS and OS against placebo in combination with chemotherapy, which met the pre-defined efficacy criteria, with good safety and no detection of new safety signal.
High incidence of esophageal cancer in China, immuno-oncology has become one of the first-line standard of care in ESCC
Esophageal cancer is one of the most common malignancies worldwide, mainly classified as squamous cell carcinoma and adenocarcinoma, and ESCC accounts for more than 90% of esophageal cancer[1]. China is a high incidence region of esophageal cancer. According to estimates of the prevalence of malignant tumours in China in 2015, there were 246,000 new cases and 188,000 deaths of esophageal cancer, ranking sixth and fourth in malignant tumors in China, respectively[2]. Since the symptoms of early esophageal cancer are often subtle, most patients are diagnosed in the middle or late stages, missing out on surgical treatment. The mainly treatment for advanced patients is systematic treatment (chemotherapy or targeted therapy), but the treatment effect is limited with the highly recurrence and metastasis rate. Therefore, new drugs and treatment schemes are urgently needed.
In recent years, immuno-oncology therapy has become one of the research priorities at home and abroad. Many studies have shown that anti-PD-1 mAb combined with chemotherapy can bring survival benefits to patients with esophageal cancer. Immune checkpoint inhibitor combined with chemotherapy has become the first-line standard treatment for esophageal cancer in China[2]. The promising results in ESCC of serplulimab will provide a new option for ESCC treatment.
Underpinned by the patient-centric strategy, serplulimab clinical layout covered high incidence tumours
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. 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, hepatocellular carcinoma, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. Up to date, more than 2,800 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.
In the field of gastrointestinal cancer, HANSIZHUANG has been approved for the treatment of MSI-H solid tumours, which could benefit for patients with MSI-H colorectal cancer and MSI-H gastric cancer. In addition, PD-1 inhibitors are less explored in neoadjuvant/adjuvant therapies for gastric cancer, and Henlius has led the way with a Phase 3 clinical study, striving to benefit gastric cancer patients from the early line of immunotherapy. As for the first-line lung cancer treatment, the NDAs of the squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC) have been accepted by the NMPA. Up to date, no PD-1 has been approved globally for first-line treatment of small cell lung cancer (SCLC), and HANSIZHUANG would potentially be the world's first PD-1 inhibitor for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of SCLC for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC, and Henlius also plans to file MAA on ES-SCLC in the EU in 2022.
Going forward, Henlius will continue conducting clinical studies for more innovative products, proactively exploring immuno-oncology combination therapy, bispecific antibodies and the antibody-drug conjugates (ADC), committing to bringing affordable and high-quality innovative biologics to patients around the world.
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 1 indication is approved for marketing in China, 2 NDAs have been accepted by the NMPA, and 9 clinical trials are ongoing across the world.
HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumors in March 2022 and actively promotes its synergy with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 9 clinical trials on immuno-oncology combination therapies worldwide in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 2,800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the treatment for squamous non-small cell lung cancer (sqNSCLC) and the first-line treatment of extensive small-cell lung cancer (ES-SCLC) have been accepted by the NMPA. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC. The MAA of ES-SCLC is expected to be filed in the EU in 2022, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC.
References
[1] Leng, Xue-Feng et al. Optimal preoperative neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma[J]. Ann N Y Acad Sci. 2020 Dec;1482(1):213-224.
[2] 食管癌诊疗指南（2022年版）. 中国国家卫生健康委员会.