Shanghai, September 22, 2023 – Henlius announced that the New Drug Application (NDA) for its innovative anti-PD-1 monoclonal antibody 汉斯状 (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA). The new indication is for the first-line treatment of PD-L1-positive unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluoropyrimidine-based and platinum-based agents, offering a new therapeutic option for patients with esophageal squamous cell carcinoma.
Previously, 汉斯状 has been approved for three indications: microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC). Henlius continues to advance the differentiated and multi-dimensional development of 汉斯状 in lung cancer, gastrointestinal tumors and other fields, aiming to deliver greater benefits to patients.
Disease Background
Esophageal cancer is the sixth leading cause of cancer death worldwide and a highly prevalent malignant tumor in China. Statistics show that the incidence and mortality of esophageal cancer in China rank sixth and fourth among all malignant tumors, respectively. Esophageal squamous cell carcinoma is the most common pathological subtype, accounting for approximately 85.79% of all esophageal cancer cases in China[1].
Due to the lack of obvious early symptoms, about 70% of patients in China are diagnosed with locally advanced or metastatic esophageal squamous cell carcinoma and lose the opportunity for surgical treatment[2]. In recent years, multiple studies have confirmed that anti-PD-1 monoclonal antibody combined with chemotherapy can bring survival benefits to esophageal cancer patients, and immune checkpoint inhibitor plus chemotherapy has become the standard first-line treatment for esophageal cancer in China[3].
Basis for This Approval
This approval is mainly based on a randomized, double-blind, multicenter Phase III clinical trial (ASTRUM-007), which evaluated the efficacy and safety of serplulimab versus placebo in combination with chemotherapy (cisplatin + 5-FU) in previously untreated patients with PD-L1-positive (PD-L1 CPS ≥ 1) advanced esophageal squamous cell carcinoma.
The results of the ASTRUM-007 study, published in the internationally renowned academic journal Nature Medicine, demonstrated that serplulimab combined with chemotherapy achieved comprehensive survival benefits in overall survival (OS) and progression-free survival (PFS), with a favorable safety profile.
To date, the findings of the ASTRUM-007 study have been presented at international academic conferences including the 2022 ESMO Asia Congress and the 2023 ASCO Annual Meeting, and have been highly recognized by the international academic community.
