Shanghai, January 17, 2023 – Henlius announced that the supplemental New Drug Application (sNDA) for HLX10 (汉斯状, generic name: serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, has been approved by the National Medical Products Administration (NMPA) of China. The approval is for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.
As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer, HLX10 ushers in a new era of immunotherapy for small cell lung cancer. Previously, HLX10 had already been approved for two indications: the treatment of microsatellite instability-high (MSI-H) solid tumors and squamous non-small cell lung cancer (sqNSCLC).
Disease Background
Lung cancer is one of the most common malignant tumors worldwide. According to GLOBOCAN data, there were 2.2 million new lung cancer cases and 1.8 million new lung cancer deaths globally in 2020, ranking first among all cancer-related deaths.
Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancer cases[2] and represents the most aggressive subtype of lung cancer. It is classified into limited-stage small cell lung cancer (LS-SCLC) and extensive-stage small cell lung cancer (ES-SCLC). Most patients are diagnosed at the extensive stage, characterized by rapid clinical progression and poor overall prognosis.
Basis for Approval
The approval of HLX10 is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multicenter Phase 3 clinical trial.
The study was conducted across 128 trial sites in multiple countries including China, Turkey, Poland (EU), and Georgia, enrolling a total of 585 participants, approximately 31.5% of whom were Caucasian.
The primary results of the study were first presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, with updated follow-up data published at the 2022 European Society for Medical Oncology (ESMO) Asia Congress in December 2022.
Notably, in September 2022, the results of the ASTRUM-005 study were published online in Journal of the American Medical Association (JAMA, Impact Factor: 157.3), one of the world’s top four general medical journals. This marks the first immunotherapy clinical trial for small cell lung cancer ever published in the main edition of JAMA, further validating the high recognition of this study by the international academic community.
