The European Lung Cancer Congress 2026 (ELCC 2026) is being held from March 25 to 28 in Copenhagen, Denmark. At the congress, Henlius announced several research findings for its innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly®) via poster presentations. The data covers a broad clinical spectrum, including consolidation therapy for limited-stage small cell lung cancer (LS-SCLC), neoadjuvant therapy for non-small cell lung cancer (NSCLC), and real-world studies (RWS) in squamous NSCLC (sqNSCLC) and extensive-stage SCLC (ES-SCLC). These results further validate the therapeutic value and clinical potential of serplulimab in lung cancer management.
Serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of SCLC and the first and only anti-PD-1 mAb to achieve success in a Phase 3 registrational study for perioperative gastric cancer*, marking global breakthroughs in both lung and gastrointestinal cancers. To date, serplulimab has been approved for indications including sqNSCLC, ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC (nsqNSCLC). It is currently marketed in over 40 countries—including China, the UK, Germany, Singapore, and India—covering nearly half of the global population. Furthermore, It has also been included in public reimbursement systems in seven EU countries, including Germany, Italy, and Spain.
Leveraging its differentiated mechanism, serplulimab has demonstrated unique advantages across multiple solid tumors. The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively.
In the lung cancer field, beyond its currently approved indications, an international multicenter phase 3 clinical trial of serplulimab combined with chemoradiotherapy for first-line treatment of LS-SCLC has completed the subject enrollment. A New Drug Application (NDA) is planned for submission in 2026. In the EU, approvals for serplulimab in sqNSCLC and nsqNSCLC are expected in 2026. Additionally, bridging trials for ES-SCLC are underway in the U.S. and Japan; notably, the head-to-head bridging trial in the U.S. has completed enrollment, with a Biologics License Application (BLA) submission to the FDA targeted for 2026.
The data presented at ELCC 2026 provide new evidence-based support for serplulimab’s clinical application in lung cancer. Key highlights include positive results for serplulimab as consolidation therapy in LS-SCLC following concurrent chemoradiotherapy (cCRT). In NSCLC, data from a neoadjuvant study (serplulimab plus chemotherapy for Stage II-IIIB NSCLC) suggests the regimen may significantly improve pathological response rates. Furthermore, real-world data reaffirmed serplulimab’s robust efficacy and tolerability in first-line sqNSCLC and its potential when combined with thoracic radiotherapy for ES-SCLC.
The research results presented at ELCC are as follows:
SCLC
Title: Serplulimab Consolidation after Concurrent Hypofractionated Chemoradiotherapy for Limited-stage Small-cell Lung Cancer
Study design: This multicenter, single-arm, phase II trial evaluates the efficacy and safety of serplulimab consolidation in response LS-SCLC patients following four cycles of carboplatin/cisplatin plus etoposide with concurrent hypofractionated radiotherapy (45Gy/3Gy/15F). Progression-free survival (PFS), overall survival (OS), and safety were assessed. Survival outcomes of patients treated with Hypo-cCRT alone in a historical cohort derived from a prospective phase III trial (NCT02688036) served as control. Inverse probability of treatment weighting (IPTW) was performed to balance baseline characteristics.
Results: With median follow-up of 29.4 months (data cutoff: Nov 25, 2025), 55 patients in serplulimab cohort and 241 in Hypo-cCRT cohort were analyzed. The median PFS was 27.5 months (95% CI: 15.7-NR) since initiation of serplulimab, with 1- and 2-year PFS rates of 63.6% (95% CI: 52.1-77.7%) and 54.0% (95% CI: 42.2-69.1%), respectively. Median OS was not reached, with 1- and 2-year OS rates of 92.7% (95% CI: 86.1-99.9%) and 78.9% (95% CI: 68.4-90.9%). After IPTW analysis, serplulimab consolidation demonstrated a significant PFS benefit over Hypo-cCRT group (HR= 0.60, 95% CI 0.41-0.90, P=0.014). It also conferred a superior OS (HR=0.48, 95% CI 0.27-0.85, P=0.011). No grade 5 toxicity was observed. The incidence of grade 3-4 immune-related adverse events was 21.8% (n=12). Grade 3-4 radiation pneumonitis and esophagitis occurred in 7.3% (n=4) and 1.8% (n=1) of patients, respectively.
Conclusion: ASTRUM-LC01 trial demonstrated that serplulimab consolidation following Hypo-cCRT yields compelling survival benefits with a manageable safety. The significant OS improvement over control group support serplulimab after Hypo-cCRT as a potential therapeutic strategy, warranting validation in randomized controlled trials.
Title: Clinical Efficacy of Consolidative Thoracic Radiotherapy Following Chemoimmunotherapy in ES-SCLC: A Real-World Comparative Study
Study design: This retrospective study reviewed the records of ES-SCLC patients who achieved disease control after first-line PD-1/PD-L1 inhibitor combined with platinum–etoposide chemotherapy between 2018 and 2024. All patients were divided into two groups based on whether they received cTRT. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), depth of radiologic response (DpR), and safety. Inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances.
Results: A total of 91 patients were included, with the cTRT group exhibiting a more favorable ECOG performance status and lower tumor burden. Unadjusted analyses revealed that patients who received cTRT had significantly longer median PFS and median OS (P < 0.001). However, given the patient selection bias in this retrospective study, IPTW was applied to adjust for confounding. After weighting, survival differences were attenuated but remained numerically in favor of the cTRT group, with a weighted median PFS of 13.77 vs. 10.07 months, and a median OS of 31.87 vs. 17.27 months. Cox analysis showed receipt of cTRT was independently associated with prolonged both PFS (HR 0.54; P = 0.036) and OS (HR 0.45; P = 0.033). DpR analysis showed a higher rate of additional tumor shrinkage in the cTRT group (74.4% vs. 46.2%; P = 0.007). Toxicities were manageable; most radiation-related events were grade 1–2 (33.3%), and no grade 5 adverse events (AEs) occurred.
Conclusion: In this real-world cohort, cTRT following chemoimmunotherapy yielded more pronounced tumor shrinkage and exerted an independent association with improved survival outcomes. Prospective randomized trials are warranted to further define the optimal role of cTRT in the immunotherapy era.
NSCLC
Title: A Prospective Study of Neoadjuvant Serplulimab Plus Chemotherapy for Stage II-IIIB Non-Small Cell Lung Cancer (NSCLC)
Study design: This prospective, single-arm study enrolled adult patients with histologically confirmed resectable or potentially resectable stage II-IIIB NSCLC. Patients received 3 cycles of neoadjuvant serplulimab plus platinum-doublet chemotherapy. Following re-assessment, eligible patients underwent curative-intent surgery, while those deemed unresectable proceeded to chemoradiotherapy. Primary endpoint was major pathologic response (MPR); secondary endpoints were pathologic complete response (pCR), objective response rate (ORR), disease control rate(DCR), and adverse events (AEs).
Results: This study enrolled 82 patients (median age, 65.5 years) and treated with at least 1 cycle of neoadjuvant therapy. 68 patients (82.9%) were squamous cell carcinoma, and 45 (54.9%) had stage IIIA/IIIB disease. The ORR and DCR were 91.5% (75/82; 95% CI: 83.2-96.5%) and 93.9% (77/82; 95% CI: 86.3-98.0%), respectively. Postoperative stage T or N downstaging was achieved in 82.6% and 55.1% of patients. Among 69 patients (84.1%) who received curative-intent surgery, MPR, pCR and R0 resection rates were 73.9%, 53.6% and 98.6%, respectively. The pCR rates were 58.2% and 38.5% for patients with squamous cell carcinoma and adenocarcinoma, respectively, and 73.3% and 48.2% for those with N2 and N0-1 stage disease. Comparable pathological response rates were found between IIA/IIB and IIIA/IIIB disease (MPR: 77.4% vs 71.2%; pCR: 51.6% vs 55.3%). Seven patients received chemoradiotherapy, and 44 received adjuvant therapy. Survival data remain immature. Grade 3-4 AEs occurred in 23.2% of patients (n=19), with 2.4% (n=2) reporting grade 3-4 immune-related AEs. Four patients (4.9%) reported grade 3-4 surgery-related complications
Conclusion: Neoadjuvant serplulimab plus chemotherapy yielded substantial pathologic responses with a manageable safety in stage II-IIIB locally advanced NSCLC.
Title: First-line Serplulimab for Advanced Squamous Non-small Cell Lung Cancer: Updated Survival of the ASTRUM-004R Trial
Study design: ASTRUM-004R is a retrospective, real-world study conducted at 14 centers in China. Patients with advanced sqNSCLC received first-line serplulimab plus platinum-based therapy, followed by serplulimab maintenance for up to 2 years or until disease progression or intolerable toxicity. The updated analysis reports comprehensive survival outcomes, including progression-free survival (PFS), overall survival (OS), and PFS analyses across key patient subgroups.
Results: As of October 31, 2025, 132 patients had been enrolled, with a median age of 69 years. Among them, 94 (71.2%) were aged ≥ 65 years, 26 (19.7%) had an ECOG performance status of 2, and 62 (47.0%) had stage IV disease. Sixty-seven patients (50.8%) underwent first-line maintenance therapy. At a median follow-up of 18.0 months, the median PFS was 14.8 months (95% CI: 11.9 - 19.6), with a 6-month PFS rate of 78.5% (95% CI: 71.5 - 86.2%). The median PFS benefit was comparable between patients receiving nab-paclitaxel and those receiving paclitaxel (17.5 vs. 15.2 months, P = 0.677), suggesting no significant difference in efficacy between the two groups. Stage III patients had a superior median PFS compared with stage IV patients (20.4 vs. 11.9 months, P = 0.009). The median OS was 29.7 months (95% CI: 29.7 - NR), with a 12-month OS rate of 90.1% (95% CI: 84.7 - 95.9%). The updated analysis showed durable antitumor activity, with an objective response rate of 66.7% (95% CI: 57.9 - 74.6%) and a disease control rate of 95.5% (95% CI: 90.4 - 98.3%). The incidence of any grade adverse events (AEs) was 36.4%, with grade ≥3 immune-related AEs reported in 6.8% of patients.
Conclusion: The updated results confirm that first-line serplulimab plus platinum-based therapy provides a significant survival benefit with a manageable safety profile in sqNSCLC, consistent with findings from the ASTRUM-004 trial. The long-term survival benefit requires further validation with additional follow-up.