From October 17 to 21, 2025, the European Society for Medical Oncology (ESMO) Annual Meeting will be held in Berlin, Germany. At this conference, the latest results from multiple studies in lung cancer and gastrointestinal tumours of Henlius' self-developed innovative anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, Hetronifly® in Europe) have been selected. Notably, the final analysis of the Phase III ASTRUM-002 trial—evaluating serplulimab plus chemotherapy as first-line treatment for advanced non-squamous non-small cell lung cancer (nsqNSCLC)—has been chosen as a Late-Breaking Abstract (LBA) and the final analysis results will be orally presented for the first time at the conference. In addition, several studies of serplulimab were selected for mini oral and poster presentations, underscoring its innovative strength and academic impact in the fields.
HANSIZHUANG is the world’s first approved anti-PD-1 monoclonal antibody (mAb) for first-line treatment of small cell lung cancer (SCLC). It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, covering nearly half of the global population. Focusing on lung and gastrointestinal cancers, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. To date, serplulimab has been approved for the treatment of squamous NSCLC (sqNSCLC), extensive-stage SCLC (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC (nsqNSCLC). Bridging studies for ES-SCLC are currently underway in the United States and Japan.
In lung cancer, serplulimab has covered the full range of first-line treatment. Beyond its three approved indications (sqNSCLC, ES-SCLC, nsqNSCLC), Henlius is conducting a global, multicenter Phase 3 trial of serplulimab plus chemotherapy and radiotherapy for first-line treatment of limited-stage SCLC (LS-SCLC). The pivotal Phase 3 ASTRUM-002 trial has garnered recognition at leading international congresses: following its initial oral presentation at WCLC 2025, its final analysis has now been selected as an LBA for ESMO 2025 and will be orally presented by its leading PI Professor Shi Yuankai (Cancer Hospital, Chinese Academy of Medical Sciences), featuring data up to August 7, 2025. Additionally, an IIT study evaluating serplulimab plus chemotherapy for induction therapy in unresectable stage IIIB-IIIC NSCLC has been selected for a Mini Oral session.
In the field of gastrointestinal cancers, the company continues to deepen its clinical exploration of serplulimab. In addition to the approved indication for ESCC, the company is actively advancing a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, expected to provide more therapeutic options for perioperative gastric cancer patients. An international, multicenter Phase 3 trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy as first-line therapy for metastatic colorectal cancer (mCRC) is also actively enrolling patients globally. At ESMO 2025, multiple IITs investigating serplulimab for neoadjuvant therapy in locally advanced gastric & rectal cancer, as well as first-line therapy for advanced pancreatic cancer have been selected for poster presentations.
The studies selected for ESMO 2025 are as follows:
Title: Final Analysis of First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer: the ASTRUM-002 Phase 3 Study
Form: LBA
Session: Mini oral session 2 : NSCLC metastatic
Number: LBA71
Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy Of Medical Sciences
Time: Oct 20 2025, 10:15 - 10:20 (Berlin local time)
Title: Surgery versus radiotherapy after induction therapy with serplulimab combined with chemotherapy for unresectable stage IIIB-IIIC non-small cell lung cancer: a randomized controlled, open-label, phase 2 trial
Form: Mini Oral
Session: Mini oral session 2: Non-metastatic NSCLC
Number: 1818MO
Leading PI: Peng Zhang, Shanghai Pulmonary Hospital
Time: Oct 20 2025, 15:25-15:30(Berlin local time)
Title: Total neoadjuvant chemotherapy plus PD-1 antibody in locally advanced gastric or gastro-esophageal junction adenocarcinoma: A proof-of-concept, phase 2 trial
Form: Poster
Abstract Number: 2862
Leading PI: Yuanfang Li, Sun Yat-sen University Cancer Center
Time: Oct 19 2025 (Berlin local time)
Title: Serplulimab Combined with CapeOX and Celecoxib as Neoadjuvant Therapy for Proficient Mismatch Repair Locally Advanced Mid-to-Low Rectal Cancer (SCAR)
Form: poster
Abstract Number: 6754
Leading PI: Kefeng Ding, The Second Affiliated Hospital of Zhejiang University School of Medicine
Time: Oct 19 (Berlin local time)
Title: First-line Serplulimab and Bevacizumab Combined with Nab-Paclitaxel/Gemcitabine Followed by mFOLFOX in Advanced Pancreatic Cancer: A Phase II Trial
Form: poster
Abstract Number: 2230
Leading PI: Jieer Ying, Zhejiang Cancer Hospital,
Time: Oct 19 (Berlin local time)
