On August 13, 2025 (Pacific Time), the World Conference on Lung Cancer (WCLC) 2025 has officially unveiled the list of accepted abstracts. Ten studies on Henlius' innovative PD-L1 ADC HLX43, anti-EGFR mAb HLX07 and anti–PD-1 monoclonal antibody(mAb) HANSIZHUANG (serplulimab) have been selected for multiple sessions, including oral presentations, poster tours, and poster presentations. Among these, 4 will be featured as oral presentations and 2 as poster tours. The selected studies span first-line treatment for non-squamous non–small cell lung cancer (nsNSCLC), squamous non–small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC). In addition, innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases.
Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases [1]. Lung cancer is classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC making up approximately 85% of all cases. NSCLC can be further divided into sqNSCLC(about 30%), nsNSCLC(about 50%), and other subtypes.
HLX43, a broad-spectrum anti-tumor PD-L1 ADC, is the first PD-L1 ADC progressed to phase 2 clinical trial development globally, exhibiting dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. HLX43 continues to demonstrate a high response rate in patients with advanced solid tumors, particularly in pretreated NSCLC patients who failed checkpoint inhibitor therapy. HLX43 exhibits superior efficacy in specific subgroups, with an objective response rate (ORR) of 47.4% in EGFR wild-type non-squamous NSCLC, while maintaining a favorable safety profile. HLX07 is a novel anti-EGFR mAb developed by Henlius, which demonstrated significant anti-tumor activity and durable efficacy when combined with serplulimab and chemotherapy in patients with EGFR high-expression sqNSCLC. At a median follow-up of 18.6 months, the high dose group reached a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months. HANSIZHUANG is the world’s first anti–PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for marketing in nearly 40 countries and regions, covering almost half of the global population. HANSIZHUANG has been approved in combination with chemotherapy as a first-line treatment for sqNSCLC, nsNSCLC and ES-SCLC.
Spotlight Oral Presentation: Demonstrating Efficacy in NSCLC
In NSCLC, At this year’s WCLC, the Phase III ASTRUM-002 study, led by Professor Yuankai Shi of the Cancer Hospital, Chinese Academy of Medical Sciences, will debut its results in an oral presentation. The study evaluates serplulimab plus chemotherapy as a first-line treatment for advanced nsNSCLC, showing a median progression-free survival (mPFS) of 11.0 months, an improvement of 5.4 months compared to chemotherapy alone, as well as clear benefit in patients with brain metastases.
Additionally, multiple investigator-initiated trials (IITs) exploring serplulimab in combination immunotherapy have been selected for Mini Oral presentations, poster tours, and poster presentations. These studies further validate the efficacy and safety of serplulimab in nsNSCLC patients with brain metastases, in EGFR-TKI–resistant cases, and in the perioperative setting for non-small cell lung cancer, underscoring its potential in broader patient populations.
The ASTRUM-002 study is a randomized, double-blind, multicentre phase 3 clinical study. Patients with locally advanced or metastatic nsNSCLC without EGFR sensitizing mutations or ALK/ROS rearrangements and no prior systemic therapy were randomized 1:1:1 to receive serplulimab + HLX04 + chemo, serplulimab +chemo, or chemo. The results indicated that serplulimab + chemo versus chemo as first-line treatment of advanced nsNSCLC significantly prolonged mPFS(11.0 months vs. 5.6 months; stratified HR= 0.55, 95% CI: 0.43-0.69, P < 0.0001), meeting the prespecified superiority criteria, with good safety profile and no new safety signals were observed. In the subgroup of patients with brain metastases, the median PFS in the serplulimab + chemo group reached 8.1 months, an extension of 4.0 months compared with the chemo group, reducing the risk of disease progression or death by 49% (HR = 0.51, 95% CI: 0.30-0.87, P = 0.0115).
Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer
Form: Oral
Session: OA05-lmmunotherapy for Special Populations
Abstract Number: 1454
Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical Sciences
Time: Sunday Sep 7, 2025 4:47 PM-4:57 PM (CEST)
A Phase 2 trial evaluated serplulimab plus bevacizumab and chemotherapy in treatment-naïve non-squamous NSCLC with brain metastases. The study enrolled 40 nsNSCLC patients with untreated brain metastases to receive first line treatment of serplulimab combined with bevacizumab, pemetrexed, and carboplatin. The median sPFS was 13.3 months. The intracranial ORR was 84.6%, with a 64.1% extracranial ORR, demonstrating potent antitumor activity. Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting.
Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN)
Form: Mini Oral
Session: MA10-Longer Follow Up and New IO Combinations
Abstract Number: 2266
Leading PI: Likun Chen, Sun Yat-Sen University Cancer Center
Time: Sep 9,2025 1:02 PM-1:07 PM (CEST)
Potential Advantageous Therapy Option for EGFR High-Expression Lung Cancer
In patients with NSCLC worldwide, the prevalence of EGFR overexpression is estimated at approximately 40%–89% (depending on histological subtype, ethnicity, and other factors), representing millions of newly diagnosed patients each year [2–4]. Notably, up to 89% of patients with sqNSCLC present with EGFR overexpression [2–3]. Henlius is actively advancing a phase 2 clinical study of HLX07, a novel anti-EGFR mAb developed by Henlius, in combination with serplulimab for the first-line treatment of EGFR high expression sqNSCLC, aiming to address the significant unmet clinical need in this population. Updated data from this study have been accepted for poster presentation at this year’s World Conference on Lung Cancer (WCLC).
This randomized, multicenter phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemotherapy. Part 3 explored the preliminary efficacy of the tri-combination regimen in systemic treatment-naïve patients with EGFR overexpression (H-score ≥150), who were enrolled and randomly assigned to group A (n=13) and group B (n=14). Two groups of patients received intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300mg) and chemotherapy.
With a median follow-up of 18.6 months, both dose groups achieved an IRRC-assessed confirmed objective response rate (ORR) of around 70%, while the median overall survival (mOS) and median duration of response (mDOR) were not reached, indicating durable responses with the potential for further improvement, alongside a manageable safety profile. Notably, the group B achieved a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months (95% CI 8.1-NE). These results demonstrate encouraging preliminary efficacy with a manageable safety profile of HLX07 plus serplulimab and chemotherapy as first-line treatment in patients with advanced sqNSCLC, supporting further investigation of this regimen.
Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 study
Form: Poster
Session: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy
Abstract Number: 1467
Leading PI: Yilong Wu, Guangdong Provincial People's Hospital
Time: Sep 9, 2025 10:00 AM-11:30 AM (CEST)
Full coverage of first-line lung cancer treatment, broad benefits in ES-SCLC
Henlius continues to expand the layout of serplulimab in the field of lung cancer, achieving full coverage of first-line lung cancer treatment. In small cell lung cancer (SCLC), based on the international multicenter Phase III ASTRUM-005 study, serplulimab has been approved in nearly 40 countries and regions worldwide, including China, the UK, Germany, Singapore, and India, for the first-line treatment of ES-SCLC. The final analysis of this study was released at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showing a 4-year OS rate of 21.9%.
For ES-SCLC, the latest results from the largest real-world study in China in this field (ASTRUM-005R) were released at the 2025 European Lung Cancer Congress (ELCC). The study showed a median rwPFS of 8.2 months and a median OS of 17.2 months, providing robust evidence to support serplulimab plus chemotherapy as a first-line treatment for ES-SCLC. At this year’s WCLC, subgroup analysis data from this study in ES-SCLC patients with a PS score ≥2, as well as results from a meta-analysis in ES-SCLC patients with ECOG PS ≥2, will be presented, demonstrating the broad benefits of immunotherapy combinations for ES-SCLC patients.
Henlius continues to accelerate the global development of serplulimab for ES-SCLC, with the first patient dosed in the Janpanese bridging study. In additon, 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).
For more research on data integrity and highlights, please stay tuned for WCLC 2025!