EC Approves Hansizhuang for Lung Cancer

Serplulimab is the world’s first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Intas’ subsidiary, Accord Healthcare Ltd (“Accord”)

The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase III study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including China, Poland, Turkey, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians. Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the Journal of the American Medical Association (JAMA), making it the first SCLC immunotherapy study to publish on JAMA. Based on ASTRUM-005, serplulimab has been approved in China, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world’s first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S. regulatory submission.

Citation; ; Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung CancerThe ASTRUM-005 Randomized Clinical Trial ;Ying Cheng, MD; Liang Han, MD; Lin Wu, PhD;.Jun Chen, PhD; Hongmei Sun, BS; Guilan Wen, MMed; Yinghua Ji, MD; Mikhail Dvorkin, MD; Jianhua Shi, MMed; Zhijie Pan, PhD; Jinsheng Shi, BMed; Xicheng Wang, MMed Yuansong Bai, MD, PhD; Tamar Melkadze, MD; Yueyin Pan, MD, PhD; Xuhong Min, BMed, Maksym Viguro, MDi et al., for the ASTRUM-005 Study Group. JAMA. 2022;328(12):1223-1232. doi:10.1001/jama.2022.16464.