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On August 19, 2026, Mountain Time (MT)，the official website of the 2026 World Conference on Lung Cancer (WCLC) released the abstracts selected for this year’s congress. Seven lung cancer studies of Henlius’ innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly^®), have been selected for oral presentation, poster tour, and poster sessions. These studies span multiple disease settings, including extensive-stage small-cell lung cancer (ES-SCLC), limited-stage small-cell lung cancer (LS-SCLC), and large-cell neuroendocrine carcinoma of the lung (LCNEC). The multidimensional data to be presented not only further solidifies the benchmark position of serplulimab in first-line treatment of ES-SCLC but also explores innovative approaches in challenging tumors lacking standard therapies and in earlier treatment scenarios. This fully demonstrates the diverse application potential and solid clinical value of serplulimab in the field of lung cancer.

In terms of clinical indication expansion, serplulimab has established a solid therapeutic advantage in first-line treatment for high-incidence cancers such as lung cancer and gastrointestinal cancers. The drug is not only the world's first* approved anti-PD-1 mAb for first-line treatment of ES-SCLC but also the world's first and only** anti-PD-1 mAb approved for perioperative indication in gastric cancer. Currently, serplulimab has been approved globally*** for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC), and gastric cancer (GC) indications, achieving comprehensive coverage for first-line treatment of advanced lung cancer.

Preclinical studies have demonstrated that serplulimab has high affinity for the PD-1 receptor and achieves steric blockade through a differentiated binding conformation. Unlike other PD-1 inhibitors, serplulimab can induce stronger PD-1 internalization, reducing PD-1 receptor presence on T cells and thereby more thoroughly alleviating immunosuppressive signaling.¹ In terms of its blocking mechanism, serplulimab not only disrupts trans PD-1/PD-L1 binding, but also interferes with the cis interaction between PD-1 and CD28. These dual mechanisms reduce PD-1 recruitment to the costimulatory molecule CD28, thereby preserving CD28 signaling, enhancing downstream AKT activity,² and promoting sustained T-cell activation.

Supported by this differentiated mechanism and robust clinical evidence, serplulimab has been approved in more than 50 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the world’s population. It has also been included in reimbursement or public healthcare coverage systems in more than 10 countries, including the United Kingdom, Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, demonstrating broad potential for global clinical use.

Reinforcing First-Line ES-SCLC Advantage and Validating Long-Term Benefits of Maintenance Therapy

In ES-SCLC, serplulimab was approved in 2023 for first-line treatment, becoming the world’s first anti-PD-1 mAb approved for the first-line treatment of SCLC. Results from the international, multicenter Phase 3 ASTRUM-005 study of serplulimab plus chemotherapy as first-line treatment for ES-SCLC have been published in three leading international journals, including JAMA, Cancer Communications, and JAMA Oncology, with key data also presented at the ASCO Annual Meeting. Final results from ASTRUM-005 previously showed a 4-year overall survival (OS) rate of 21.9%, demonstrating durable and clinically meaningful survival benefit for patients with ES-SCLC.

At WCLC 2026, a post hoc analysis and meta-analysis led by Professor Haifeng Liu of Jilin Cancer Hospital will evaluate the efficacy and safety of serplulimab monotherapy as first-line maintenance treatment for ES-SCLC. Based on a post hoc analysis of ASTRUM-005, the study compares serplulimab with several maintenance strategies, including atezolizumab and atezolizumab plus lurbinectedin. As of May 7, 2024, from the maintenance baseline, serplulimab achieved a median OS of 15.6 months (95% CI: 14.0–17.9), a median progression-free survival (PFS) of 4.1 months (95% CI: 2.8–5.2), and a rate of grade ≥3 treatment-related adverse events (TRAEs) of 15.8%. In this inter-study comparison, serplulimab was associated with more favorable OS and PFS than atezolizumab and with more favorable OS and safety than atezolizumab plus lurbinectedin.

In addition, several investigator-initiated trials (IITs) will report findings at the congress, further expanding combination treatment strategies for first- and second-line ES-SCLC.

Title: First-line Maintenance with Serplulimab for Extensive-Stage Small Cell Lung Cancer: A Post-hoc Analysis and Meta-analysis

Form: Poster

Number: P3.317

Study design: Patients in ASTRUM-005 who had no progressive disease after completion of induction therapy and subsequently received at least one dose of serplulimab during the maintenance phase were included in the survival and safety analyses. OS, blinded independent central review (BICR)-assessed progression-free survival (PFS), and the incidence of grade ≥3 treatment-related adverse events (TRAEs) during the maintenance phase were compared between ASTRUM-005 and IMforte. A matching-adjusted indirect comparison was used for OS and PFS comparisons, with adjustment for age, liver metastatic status, and performance status.

Results: The post-hoc analysis of ASTRUM-005 included 323 patients, of whom 278 had achieved an objective response or stable disease during induction therapy based on BICR assessment and had at least one response evaluation during the maintenance phase. As of May 7, 2024, the median follow-up was 40.2 months (interquartile range, 36.8-42.3). From the maintenance baseline, the median OS with serplulimab was 15.6 months (95% confidence interval [CI], 14.0- 17.9), and the median PFS was 4.1 months (95% CI, 2.8-5.2). Grade ≥3 TRAEs during the maintenance phase were reported in 51 patients (15.8%). As shown in Table 1, compared with atezolizumab, serplulimab was associated with more favorable OS (hazard ratio [HR], 0.63; 95% CI, 0.48-0.81) and PFS (HR, 0.62; 95% CI, 0.49-0.80); compared with atezolizumab plus lurbinectedin, serplulimab was associated with improved OS (HR, 0.74; 95% CI, 0.57-0.97), similar PFS (HR, 1.01; 95% CI, 0.77-1.31), and an approximately 50% lower risk of grade ≥3 TRAEs (risk ratio, 0.52; 95% CI, 0.38-0.72).

Conclusion: In this inter-study comparison, serplulimab was associated with more favorable OS and PFS than atezolizumab and with more favorable OS and safety than atezolizumab plus lurbinectedin.

Title: Surufatinib Combined With First-Line Serplulimab and Chemotherapy for ES-SCLC: A Prospective Single-arm Trial

Form: Poster

Number: P3.331

Study design: This single-arm, prospective trial enrolled newly diagnosed patients with ES-SCLC. Patients received surufatinib 200 mg orally once daily, serplulimab 300 mg intravenously on day 1, etoposide 100 mg/m² intravenously on days 1-3, with either carboplatin AUC 5 or cisplatin 75 mg/m² on day 1 of each 21-day cycle, followed by maintenance therapy with surufatinib and serplulimab. Tumor assessments were performed every 2 cycles (±7 days) according to RECIST version 1.1. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.

Results: As of January 21, 2026, 21 eligible patients were enrolled. The median age was 70 years (range: 55-79), 19 (90.5%) were male, and 17 (81.0%) had a history of smoking. Nineteen patients (90.5%) had an ECOG performance status (PS) of 0-1, while 2 (9.5%) had a PS of 2. Liver, brain, and bone metastases were each present in 14.3% of patients (n=3 per site). Among 20 evaluable patients, 18 (90.0%) achieved a partial response (PR), and 2 patients (10.0%) achieved stable disease (SD), resulting in an ORR of 90.0% and a DCR of 100%. With a median follow-up of 22.3 months, the median PFS was 9.9 months (95% CI: 8.6-not reached), numerically exceeding the 5.7- and 6.9-month median PFS reported in historical benchmark trials. OS data remains immature. The most common treatment emergent adverse events (TEAEs) were myelosuppression (71.4%), predominantly grade 1-2 (52.4%), with 4 patients (19.0%) experiencing grade 3-4 events. Four patients (19.0%) reported immune-related AEs (irAEs). No treatment-related death occurred. The overall safety profile was manageable and numerically superior to historical first-line quadruplet regimens.

Conclusion: Surufatinib combined with first-line serplulimab and chemotherapy demonstrated durable antitumor activity and promising survival benefits that compare favorably against historical first-line quadruplet regimens, alongside a manageable safety profile. These preliminary results warrant further validation in larger cohorts with long-term follow-up. This study is still ongoing.

Title: Second-line Serplulimab Plus Anlotinib and Nab-paclitaxel for ES-SCLC After First-line Immunochemo therapy: A Phase II Study

Form: Poster

Number: P3.283

Study design: This single-arm, phase II study enrolled adult (≥18 years) ES-SCLC patients with confirmed disease progression after first-line immunochemotherapy and an ECOG performance status of 0-1. Patients received serplulimab (300 mg) combined with anlotinib (8 mg on days 1-14) and nab-paclitaxel (100 mg/m2) every three weeks for 4-6 cycles, followed by maintenance therapy with serplulimab plus anlotinib until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was objective response rate (ORR) per RECIST v1.1; secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Results: As of November 17, 2025, 20 patients were enrolled (median age 66.5 years; 75.0% male). Baseline liver, bone, and brain metastases were present in 40.0% (n=8), 45.0% (n=9), and 35.0% (n=7) of patients, respectively. The predominant pattern of progression after first-line therapy was distant metastasis (60.0%, n=12). The regimen achieved a confirmed ORR of 70.0% (14/20; 95% CI: 45.7-88.1%), with all responders achieving a partial response. At a median follow-up of 11.0 months, the median PFS was 4.6 months (95% CI: 3.7- NR). Exploratory subgroup analysis revealed survival benefit was predominantly observed in the subgroup of patients who transitioned to maintenance therapy, suggesting a potential signal of durable efficacy with sustained treatment exposure (P=0.005). Comparable PFS was observed regardless of first-line PD-1 orPD-L1 inhibitor exposure (P=0.759). The incidence of grade 3-4 immune-related adverse events (irAEs) was 20.0% (n=4), and grade 3-4anlotinib-related AEs occurred in 15.0% of patients (n=3). The safety profile was manageable, and no new safety signals were identified.

Conclusion: The triplet combination of serplulimab, anlotinib and nab-paclitaxel demonstrated promising antitumor activity with an ORR of 70%in ES-SCLC patients progressing on prior immunochemotherapy. With a manageable safety profile, this regimen represents a potentially effectivesalvage regimen that warrants further validation in larger cohorts.

Title: Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive-Stage Small Cell Lung Cancer

Form: Poster

Number: P2.186

Study design: This prospective study (NCT05873790) enrolled treatment-naïve ES-SCLC patients. All participants received serplulimab combined with etoposide/platinum for up to 6 cycles, followed by serplulimab maintenance. Plasma samples were collected at baseline (T0), after 2 cycles (T1), after 6 cycles (T2), at 6 months post-chemotherapy cessation, and upon tumor progression. ctDNA was interrogated using an ultra-deep NGS panel targeting 2,365 cancer-relevant genes (mean coverage depth ~30,000×). Kaplan-Meier curves and log-rank tests were performed in survival analyses.

Results: Among 25 evaluable patients, the median progression-free survival (PFS) was 7.14 months. Pre-treatment analysis revealed high concordance (76%) between tissue and plasma mutations. Notably, baseline mutations in TMEM132D, MTAP, FTMT, and NA3V were significantly associated with shorter PFS (all P<0.015), suggesting that the initial genomic landscape influences intrinsic resistance. Longitudinal monitoring showed that ctDNA-MRD dynamics robustly stratified outcomes. Patients achieving MRD clearance during treatment had a significantly longer median PFS of 11.51 months compared to 6.63 months for those with persistent positivity (P=0.009). Specifically, MRD status at the T1 landmark (after 2 cycles of chemo-immunotherapy) strongly predicted survival (median PFS: not reach vs. 6.43 months, P=0.005). Furthermore, ctDNA clearance correlated with radiographic tumor shrinkage (R=0.457, P=0.028). Most patients exhibited MRD conversion to positivity or increased ctDNA levels at tumor progression. Crucially, molecular progression (MRD re-appearance or ctDNA elevation) preceded radiographic evidence of disease progression in 4 patients, providing a median lead time of 1.5 to 2.2 months.

Conclusion: This prospective study validates ctDNA-MRD as a robust prognostic biomarker in ES-SCLC treated with first-line serplulimab-based chemo-immunotherapy. Early ctDNA clearance identifies patients with superior clinical outcomes, while longitudinal monitoring provides a critical window for early intervention by detecting relapse months before traditional imaging.

Moving Treatment Earlier in LS-SCLC to Address Unmet Clinical Needs

In LS-SCLC, the global enrollment of the international, multicenter, registrational Phase 3 ASTRUM-020 study evaluating serplulimab plus concurrent chemoradiotherapy as first-line treatment has been completed. Meanwhile, multiple IITs are extending serplulimab into earlier treatment settings for LS-SCLC, addressing important evidence gaps in the field.

At WCLC 2026, a neoadjuvant study led by Professor Wenzhao Zhong of Guangdong Provincial People’s Hospital has been selected for a Mini Oral presentation. The study evaluates the efficacy and safety of neoadjuvant serplulimab plus chemotherapy in patients with stage IIB–IIIB (N2) LS-SCLC. As of January 2026, among 40 patients who underwent radical resection, the pathologic complete response (pCR) rate was 40.0%, the major pathologic response (MPR) rate was 62.5%, and the R0 resection rate was 92.5%. The study also found that MRD clearance after neoadjuvant therapy was associated with pCR, while surgery further facilitated MRD clearance, providing important clinical evidence for immunotherapy-based neoadjuvant treatment in LS-SCLC.

In addition, data from a single-arm Phase 2 study led by Professor Mengzhao Wang and Professor Yan Xu of Peking Union Medical College Hospital evaluating serplulimab plus concurrent chemoradiotherapy in LS-SCLC will also be presented. As of March 24, 2026, the 6-month and 12-month PFS rates were 90.5% and 71.2%, respectively; the 12-month OS rate was 97.9%; ORR and DCR were both 98.3%; and the 12-month duration of response (DoR) rate was 69.1%. The results suggest that serplulimab plus concurrent chemoradiotherapy followed by serplulimab maintenance therapy demonstrates promising antitumor activity, favorable early survival trends, with acceptable tolerability and manageable safety. Together with ASTRUM-020, this study advances immunotherapy into the concurrent chemoradiotherapy setting and further strengthens the clinical evidence base for serplulimab in LS-SCLC.

Title: Pathological Response and MRD Dynamics After Neoadjuvant Serplulimab Plus Chemotherapy in Stage IIB-IIIB(N2) LS-SCLC

Form: Mini Oral

Session: Expanding Therapeutic Frontiers in SCLC: ADCs, T-Cell Engagers, and First-Line Strategies

Number: MO15.03

Leading PI: Wenzhao Zhong, Guangdong Provincial People's Hospital

Time: 12:42-12:47 PM, September 15

Study design: This multicenter, single-arm phase II trial (NCT06911606) enrolled adult patients with histologically or cytologically confirmed, treatment-naïve stage IIB-IIIB (N2) LS-SCLC. Patients received neoadjuvant therapy consisting of 4 cycles of serplulimab at 300 mg combined with etoposide and either cisplatin or carboplatin. Following neoadjuvant treatment, resectability was assessed by a multidisciplinary team. Eligible patients underwent radical resection within 4-6 weeks after the last neoadjuvant dose, while inoperable patients proceeded to radiotherapy. The primary endpoint was pathological complete response (pCR). Key secondary endpoints included R0 resection rate, major pathological response (MPR), objective response rate (ORR), disease control rate (DCR), event-free survival (EFS), and safety. Longitudinal plasma samples were collected at key clinical landmarks throughout the treatment course, with exploratory analyses focusing on minimal residual disease (MRD) dynamics as assessed by circulating tumor DNA (ctDNA).

Results: As of January 2026, enrollment of 45 patients has been completed (median age 62 years; 24.4% stage IIB, 48.9% stage IIIA, 26.7% stage IIIB). Neoadjuvant immunochemotherapy achieved an ORR of 88.9% (40/45; 95% CI, 76.0–96.3%) and a DCR of 100% (45/45; 95% CI, 92.1–100.0%). Among them, 40 (88.9%) underwent radical resection, with pCR, MPR, and R0 resection rates of 40.0% (16/40), 62.5% (25/40), and 92.5% (37/40), respectively. Pathological T and N downstaging were achieved in 87.5% (35/40) and 72.5% (29/40) of surgical patients, respectively. After a median follow-up of 11.0 months, the median EFS was not reached, and the 12 month EFS rate was 86.1% (95% CI, 74.3–99.8%). Recurrence rates in surgical patients were 9.1% (1/11) in stage IIB, 5.3% (1/19) in stage IIIA, and 40.0% (4/10) in stage IIIB. Among the 28 patients with evaluable MRD data, 96.4% (27/28) were baseline positive. The MRD clearance rate was 47.8% (11/23) after neoadjuvant therapy and 77.8% (21/27) after surgery. Preoperative MRD negative patients achieved a significantly higher pCR rate than those with MRD positive (66.7% vs. 15.4%; P=0.015). Grade 3–4 adverse events occurred in 60.0% of patients, the most common being decreased neutrophil count (51.1%); no new safety signals were identified.

Conclusion: Neoadjuvant serplulimab plus chemotherapy followed by surgery demonstrated encouraging efficacy and an acceptable safety profile in patients with stage IIB-IIIB (N2) LS-SCLC, yielding high rates of pCR, MPR, and R0 resection. MRD clearance after neoadjuvant therapy was associated with pCR, and surgery further facilitated MRD clearance. The early EFS data are promising; nevertheless, long-term follow-up is ongoing to further confirm the survival benefits of this strategy.

Title: Serplulimab Combined with Concurrent Chemoradiotherapy Followed by Serplulimab Therapy for LS-SCLC: A Phase 2 Trial

Form: Poster

Number: P3.288

Study design: This multicenter, prospective, single-arm, phase 2 trial (NCT06295926) enrolled treatment-naive patients with histologically or cytologically confirmed LS-SCLC and an ECOG performance status of 0-1. Eligible patients received 4 cycles of serplulimab administered concurrently with etoposide plus cisplatin/carboplatin and thoracic radiotherapy, followed by serplulimab maintenance therapy until disease progression or for a maximum of 1 year. Serplulimab 300 mg was administered intravenously on day 1 of each 3-week cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and safety profile.

Results: Overall, 59 patients were enrolled in the study, with a median age of 62 years and a male predominance of 79.7% (47/59). Disease stage distribution included 91.5% (54/59) patients with stage III, 50.9% (30/59) with N2 nodal disease and 32.2% (19/59) with N3 nodal disease. The combination regimen achieved an ORR and a DCR of 98.3% (58/59; 95% CI: 90.91-99.96%) for both endpoints, with a 12-month DoR rate of 69.1% (95% CI: 56.13-84.96%). At the data cutoff date (March 24, 2026), the median follow-up duration was 16.4 months. Although survival data are not yet mature, the 6-month and 12-month PFS rates were 90.5% (95% CI: 82.83-98.80%) and 71.2% (95% CI: 58.89-86.05%), respectively; the 12-month OS rate was 97.9% (95% CI: 93.83-100.00%). All enrolled patients completed the 4-cycle combination therapy, and 79.7% (47/59) received serplulimab maintenance therapy. The incidence of Grade 3-4 adverse events (AEs) was 52.5% (31/59), and Grade 3-4 immune-related AEs occurred in 11.9% (7/59) of patients. Grade 3-4 radiation pneumonitis and immune-mediated pneumonitis were observed in only 5.1% (3/59) and 8.5% (5/59) of patients. No Grade 5 AEs were observed.

Conclusion: In this ongoing phase 2 trial, serplulimab combined with cCRT followed by serplulimab maintenance therapy has demonstrated promising antitumor activity and a favorable early survival trend, with acceptable tolerability and manageable safety profile. Longer follow-up is warranted to validate the survival benefits of this regimen.

Exploring First-Line Treatment for LCNEC, a Rare and Highly Aggressive Tumor Type

During the poster tour session at WCLC 2026, a multicenter, single-arm Phase 2 study presented by Professor Ying Liu of Jilin Cancer Hospital will evaluate the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for locally advanced or metastatic LCNEC. The findings show that serplulimab plus chemotherapy delivers encouraging clinical activity with acceptable safety in the first-line treatment of LCNEC, supporting further investigation in this rare and highly aggressive malignancy.

Title: Serplulimab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic LCNEC: A Phase II Trial

Form: Poster Tour

Session: Mesothelioma, Thymoma, and Other Thoracic Tumors

Number: PT2.05.02

Presenter: Ying Liu, Jilin Cancer Hospital

Time: 1:53 PM - 2:01 PM, September 14

Study design: This prospective, open-label, multicenter, single-arm phase II trial enrolled patients with pathologically confirmed locally advanced or metastatic LCNEC without prior immunotherapy or active CNS metastases. Patients received serplulimab 4.5 mg/kg, etoposide 100 mg/m², and carboplatin AUC 5 or cisplatin 75 mg/m² every 3 weeks for 4 cycles, followed by serplulimab maintenance until progression, unacceptable toxicity, or 2 years, whichever occurred

first.

Results: As of March 2026, 39 patients were enrolled, and 37 were included in the analysis. The median age of patients was 65 years (range, 40-79); most patients were male (27/37; 73.0%). A total of 86.5% of patients had metastatic disease (32/37), with bone metastases being the most common site (11/37, 29.3%), followed by liver and brain metastases with equal frequency (7/37, 18.9%). After immunochemotherapy, the ORR was 56.8% (21/37; 95% CI, 39.5-72.9), with all responses being partial responses, and the DCR was 86.5% (32/37; 95% CI, 71.2-95.5). At the time of data cutoff, the median follow-up time was 9.5 months, with 25 progression events observed (67.6%), yielding a median PFS of 5.5 months (95% CI, 4.1-8.9). The 6-month and 12-month PFS rates were 45.8% and 15.9%, respectively. The OS data are immature, and the 12-month OS rate was 72.0%. Treatment-related adverse events occurred in 56.8% of patients, with grade 3-4 reported in 18.9%. Serious adverse events (SAEs) occurred in 16.2% of patients, and no treatment-related SAEs were observed.

Conclusion: Serplulimab combined with chemotherapy demonstrated encouraging clinical activity and acceptable safety as a first-line treatment for LCNEC in this ongoing trial, supporting further exploration in this rare and aggressive malignancy.