March 27, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the latest results of the real-world study (ASTRUM-005R) of the company’s self-developed innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab, trade name: Hetronifly^® in Europe) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) were released as poster presentation at the 2025 European Lung Cancer Congress (ELCC). The ASTRUM-005R study, led by Lin Wu from Hunan Cancer Hospital and Chengping Hu from Xiangya Hospital, Central South University, is the largest real-world study in the field of ES-SCLC in China to date. The study confirms the real-world efficacy and favorable safety of serplulimab in ES-SCLC, corroborating the results of the ASTRUM-005 study and providing strong supporting evidence for the use of serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC.

Lung cancer is one of the most common malignancies around the world. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases^[1]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. HANSIZHUANG is the world’s first approved anti-PD-1 monoclonal antibody for first-line treatment of SCLC and the EU’s first and only approved anti-PD-1 monoclonal antibody for first-line treatment of ES-SCLC. To date, HANSIZHUANG has been approved in 30 countries and regions including China, Europe and Southeast Asia, licensed out to over 100 countries and regions including the U.S., Europe, Southeast Asia, the Middle East, and North Africa, benefiting over 100,000 patients.

Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,900 subjects enrolled in China, the U.S., Japan, Turkey, Poland, Georgia and other countries and regions, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to squamous non-small cell lung cancer (sqNSCLC), ES-SCLC and non-squamous non-small cell lung cancer (nsNSCLC), the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC).

The latest data of the ASTRUM-005R study released at 2025 ELCC is as follows:

Title

Real-world outcomes in extensive-stage small cell lung cancer treated with first-line serplulimab: The nationwide observational ASTRUM-005R study

Study Design

This nationwide observational study was conducted in China and included patients with pathologically confirmed ES-SCLC who received serplulimab as first-line treatment. All patients were managed according to current clinical guidelines and followed until death or loss to follow up. Real-world progression-free survival

(rwPFS), overall survival (OS), tumor response, and adverse events (AEs) were assessed to evaluate the real-world outcomes.

Results

Clinical data from 635 patients were analyzed, with a median follow-up of 14.9 months. Among 630 patients with measurable disease and at least one post-treatment evaluation, 7 achieved complete response, and 428 achieved partial response, representing an overall response rate (ORR) of 69.0%. The median rwPFS was 8.2 months (95% CI, 7.4-9.2). The median OS was 17.2 months (95% CI, 15.4-19.8). Patients with baseline brain metastases had a numerically lower median rwPFS than those without brain metastases (7.4 vs. 8.3 months, log-rank p = 0.431). Patients with liver metastases had a worse median rwPFS compared to those without liver metastases (6.4 vs. 9.3 months, log-rank p< 0.001). AEs were reported in 233 patients (36.7%),with 81 patients(12.8%) experiencing grade 3AEs. Treatment interruptions due to AEs were documented in 78 patients (12.3%), and 3 patients (0.5%) reported AE-related deaths. Serplulimab-related AEs were observed in 20.5% of patients, predominantly grade 1-2 (16.7%), with no new safety signals.

Conclusion

This large-scale, nationwide observational study confirms the real-world efficacy and favorable safety of serplulimab in ES-SCLC. The results support serplulimab-based immunochemotherapy in broader patient populations for this setting.

【Reference】

[1] Eskandar A, Ahmed A, Daughtey M, et al. Racial and sex differences in presentation and outcomes of small cell lung cancer in the United States: 1973 to 2010[J].Chest, 2015,147(4): e164-e165.