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The Phase 3 Clinical Study Results of Novel Anti-PD-1 mAb Serplulimab for the First-Line Treatment of ESCC Released at ESMO Asia Congress 2022


On December 2, 2022, the study results of ASTRUM-007, Henlius’ phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) as first-line treatment for patients with esophageal squamous cell carcinoma (ESCC), were released in the European Society for Medical Oncology Asia (ESMO Asia) Congress. The results were presented by Professor Jing Huang from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The NDA of Serplulimab for the treatment of ESCC has been accepted by the National Medical Products Administration (NMPA).

Abstract of ASTRUM-007 is as follows:

Title: First-line serplulimab versus placebo in combination with chemotherapy in PD-L1-positive oesophageal squamous cell carcinoma (ASTRUM-007): a randomised, double-blind, multicentre phase 3 study

Leading PI: Jing Huang, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Abstract No.: 69O

Form: Oral presentation

Session: Proffered Paper session/Gastrointestinal tumours

Presentation Time: 2 December 2022, 16:55 - 17:05 (UTC+8)

Study design

ASTRUM-007 (NCT03958890) is a randomised, double-blind, multicentre, phase 3 study aimed to compare the efficacy and safety of serplulimab, a novel anti-PD-1 antibody, versus placebo in combination with chemotherapy in patients with previously untreated, PD-L1–positive (combined positive score ≥1), advanced oesophageal squamous cell carcinoma (ESCC). Eligible patients were randomised 2:1 to receive serplulimab 3 mg/kg or placebo combined with cisplatin 50 mg/m2 and 5-fluorouracil 1200 mg/m2 daily on days 1–2 intravenously every 2 weeks. Co-primary endpoints were progression-free survival (PFS) assessed by the independent radiology review committee per RECIST v1.1 and overall survival (OS).


• Efficacy

Median PFS was significantly longer in serplulimab plus chemotherapy group than that in placebo plus chemotherapy group (5.8 vs. 5.3 months; hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.48–0.75; p<0.0001). Median OS was also significantly improved with the addition of serplulimab (15.3 vs. 11.8 months; HR 0.68, 95% CI 0.53–0.87; p=0.0020).

• Satety

Grade ≥3 treatment-related adverse events (AEs) occurred in 201 (52.6%) patients receiving serplulimab plus chemotherapy and in 81 (48.2%) receiving placebo plus chemotherapy.


Serplulimab in combination with chemotherapy administered every 2 weeks significantly improved PFS and OS compared with chemotherapy alone in first-line treatment of PD-L1–positive advanced ESCC, which can be considered as a new standard option for this patient population.


HANSIZHUANG (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA, and 11 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC). Its synergy with in-house products of the company and innovative therapies are forging ahead. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies 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 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White 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 first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). 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 the related clinical trial has also become the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designation by the FDA for treatment of SCLC.