Hetronifly (serplulimab) / Fosun Pharma, PT Kalbe Farma, Intas, Lotus Pharmaceutical - LARVOL DELTA

Matching adjusted indirect comparison of safety between atezolizumab and serplulimab for patients with ES-SCLC (ESMO Asia 2025) - "We conducted an indirect comparison to evaluate the safety of atezo and serplu in patients with ES-SCLC. Patients who received atezo or serplu combined with carboplatin and etoposide as first-line treatment for ES-SCLC in phase 3 trials were included in this analysis. In this MAIC analysis of ES-SCLC, compared with atezo, serplu shows a higher incidence of fatal and grade ≥3 TEAEs, and a broader spectrum of common TEAEs. Given the nature of indirect comparison, further studies are warranted to verify the findings."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Clinical outcomes and safety of continuous immunotherapy and anti-angiogenic combination therapy beyond progression in patients with extensive-stage small cell lung cancer: A retrospective real-world study (ESMO Asia 2025) - "This multi-center retrospective study aimed to investigate the efficacy of continuous immunotherapy (I) and addition of anti-angiogenic agent (A) in relapsed ES-SCLC. We retrospectively reviewed the medical records of ES-SCLC patients treated with first-line I+C therapy in three medical centers in Shandong Province. From Jan 2020 to Dec 2024, 354 patients were enrolled and 241 (68.1%) received PD-L1 antibody including atezolizumab, durvalumab, adebrelimab, while 113 (31.9%) received PD-1 antibody such as serplulimab. Continuous immunotherapy beyond progression in ES-SCLC demonstrates a trend toward prolonged second-line PFS, but does not improve the overall survival. In the second-line treatment, chemotherapy remains an indispensable cornerstone."

Clinical data • Combination therapy • Real-world • Real-world evidence • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Real-world study of serplulimab as first-line treatment for advanced squamous non-small-cell lung cancer (ESMO Asia 2025) - "In this real-world study, serplulimab exhibited remarkable efficacy and a well-tolerated safety profile, supporting its use as a highly effective first-line immunotherapy option for advanced sqNSCLC."

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of neoadjuvant serplulimab in locally advanced driver gene-negative NSCLC: A multicenter real-world study (ESMO Asia 2025) - "Neoadjuvant serplulimab-chemotherapy demonstrated promising efficacy and manageable toxicity in real-world locally advanced NSCLC. Survival outcomes require longer follow-up to assess clinical benefit."

Clinical • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Induction serplulimab and cetuximab combined with chemotherapy followed by radiotherapy for unresectable locally advanced HNSCC: A single-arm, prospective, phase II study (ESMO Asia 2025) - "Patients received serplulimab (4.5 mg/kg, Q3W) + cetuximab (400 mg/m2 loading, followed by 250 mg/m2, QW) + liposomal paclitaxel (135 mg/m2, D1) + cisplatin (75 mg/m2, Q3W), for 3 weeks per cycle, with 2 total treatment cycles. In patients with unresectable LA-HNSCC, this induction regimen showed preliminary efficacy and manageable toxicity. Further follow-up is required to confirm the survival benefit."

Clinical • Metastases • P2 data • Head and Neck Cancer • Hypopharyngeal Cancer • Nasopharyngeal Carcinoma • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Serplulimab in advanced, recurrent, or metastatic cervical cancer: A prospective multicenter real-world study (ESMO Asia 2025) - "Serplulimab demonstrated significant efficacy and a manageable safety profile in patients with advanced, recurrent, or metastatic cervical cancer. The absence of significant differences in efficacy observed in the subgroup analysis further indicates that serplulimab is a promising treatment option for patients with advanced, recurrent, or metastatic cervical cancer in the post-initial settings."

Clinical • Metastases • Real-world • Real-world evidence • Cervical Cancer • Oncology • Solid Tumor

Identification of potential immune biomarkers associating to clinical benefit from intensive chemotherapy combined with serplulimab and trastuzumab in advanced HER2+ gastric cancer: A post-hoc analysis of the ASTRUM study (ESMO Asia 2025) - P2 | "Expolatoring immune biomarkers is essential for patients' straitification and optimizing therapeutic strategy. 40 pts enrolled from July 2022 to September 2024 received S (4.5 mg/kg, D1, Q3W), T (initial 8 mg/kg, D1, then 6 mg/kg, D1, Q3W), and DOS chemotherapy (oxaliplatin 100 mg/m2, docetaxel 40 mg/m2 IV, S-1 40–60 mg BID D1–14 Q3W)... Integrated tumour and circulating immune signatures forecast durable efficacy of treatment. baseline immune biomarkers serve as putatively predictive biomarkers for clinical benefit."

Biomarker • Clinical • IO biomarker • Metastases • Retrospective data • Gastric Cancer • Oncology • Solid Tumor • CCL19 • CD22 • CD8 • CD86 • CRTAM • HER-2 • IL6 • KDR • MMP1 • PGF • TNFRSF18 • XCL2 • ZAP70

Updated outcome and ctDNA profiling in advanced HER2+ gastric cancer patients treated with DOS plus serplulimab and trastuzumab: A phase II multicenter trial (ESMO Asia 2025) - P2 | "DOS with plus S and T displayed sustained anti-tumor activity. ctDNA dynamics, especially blood ERBB2 CN hold substantial clinical utility for evaluating clinical outcomes in advanced HER2+ gastric cancer."

Circulating tumor DNA • Clinical • IO biomarker • Metastases • P2 data • Tumor mutational burden • Gastric Cancer • Oncology • Solid Tumor • HER-2 • TMB

A multicenter randomized trial of serplulimab after mFOLFOX6 and HLX04 induction in first-line treatment of MSS metastatic colorectal cancer (ESMO Asia 2025) - P2 | "This preliminary analysis suggests that first-line induction with mFOLFOX6 and HLX04, followed by the addition of serplulimab, may provide clinical benefit in MSS mCRC. mIHC data offers unique insights of tumor microenvironment. These findings warrant further validation and long-term follow-up."

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • CD4 • FOXP3

China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer (Henlius Press Release) - "HANSIZHUANG is poised to become the world's first anti-PD-1 monoclonal antibody approved for perioperative treatment of gastric cancer."

China filing • Priority review • Gastric Cancer

PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer (clinicaltrials.gov) - P3 | N=382 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P3 trial • pMMR • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): A phase II trial. (ASCO-GI 2026) - P=N/A | "Funded by National Natural Science Foundation of China, Hospital Funded Clinical Research, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Clinical Trial Registration Number: NCT06688786 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • pMMR • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

First line PD-L1/1 inhibition based therapies in elderly patients with ES-SCLC: a Systematic Literature Review and Network Meta-Analysis (ESMO-IO 2025) - "Currently, PD-1/PD-L1 inhibitors with platinum and etoposide (EP) have been adopted as standard first-line therapy and idemonstrated survival benefits in the overall population, while the magnitude of benefit and optimal agent in elderly patients remain unclear.Methods Following PRISMA-NMA guidelines, PubMed and ClinicalTrials.gov were searched up to 29 August 2025. Eligible RCTs compared first-line PD-L1 or PD-1 inhibitors—atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab, pembrolizumab, socazolimab, benmelstobart(+anlotinib), nivolumab, or toripalimab with or without EP in ES-SCLC...Atezolizumab-EP ranked highest for OS (SUCRA=0.88), followed by Benmelstobart + anlotinib -EP (SUCRA = 0.86) and serplulimab-EP (SUCRA = 0.77), whereas durvalumab-EP (SUCRA = 0.36) and socazolimab-EP (SUCRA = 0.29) showed relatively modest effects.Conclusions First-line PD-L1/PD-1 inhibition plus EP confers a clinically meaningful survival advantage in elderly patients with..."

Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Front Immunol) - "Compared with chemotherapy, except for ipilimumab+chemo [HR = 0.92,95%CI: (0.59-1.40)], atezolizumab+chemo [HR = 0.88, 95%CI: (0.56-1.40)], and durvalumab+chemo [HR = 0.84, 95% CI: (0.52-1.40)], durvalumab+ tremelimumab+chemo [HR = 0...Cemiplimab [HR = 0.48, 95% CI: (0.34-0.67)] showed the best OS benefit...Sugemalimab+chemo provided the best survival benefit [HR = 0.34, 95% CI: (0.24-0.48)]. For PD-L1≥50% tumors, penpulimab showed excellent OS and PFS; for PD-L1 1-49% tumors, pembrolizumab+chemo and camrelizumab+chemo achieved the best OS and PFS, respectively; for PD-L1≥1% tumors, the tislelizumab+chemo and camrelizumab+chemo showed the best OS and PFS results, while for tumors with PD-L1 <1%, both nivolumab and serplulimab+chemo provided significant survival benefit...Ipilimumab+chemo had the highest incidence of adverse events (AEs) [OR = 2.0, 95% CI:(1.5-2.7)]. https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447."

Checkpoint inhibition • Clinical • IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Comparative effectiveness and safety of systemic therapies for treatment-naïve, PD-L1 expression <1% advanced NSCLC: a systematic review and network meta-analysis. (PubMed, Transl Lung Cancer Res) - "In terms of OS, pembrolizumab + chemotherapy + canakinumab (Pembro-chemo-canakinumab) (SUCRA =0.90) showed great potential in improving outcomes, although its long-term efficacy still needed to be validated...For squamous patients, nivolumab + ipilimumab ± chemotherapy (Nivo-ipi-chemo) led in OS, while serplulimab + chemotherapy in PFS. First-line personalized treatment for PD-L1 <1%, advanced NSCLC should be histology-based, balancing efficacy and toxicity. Pembro-chemo and nivolumab + chemotherapy + bevacizumab combinations are recommended as the optimal first-line options for non-squamous patients, and Nivo-ipi-chemo for squamous patients."

HEOR • IO biomarker • Journal • Retrospective data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

ASTRUM-005: A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov) - P3 | N=585 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed

IO biomarker • Trial completion • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "The addition of serplulimab to chemotherapy led to significantly longer progression-free survival in patients with locally advanced or metastatic non-squamous NSCLC compared with chemotherapy alone and represents an alternative first-line treatment option for this patient population. HLX04 plus serplulimab and chemotherapy did not confer further statistical benefit compared with serplulimab plus chemotherapy."

IO biomarker • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial (Lancet Respir Med) - "Median progression-free survival was 12·6 months (95% CI 8·7–14·0; 123 events) in group A, 11·0 months (95% CI 8·4–12·7; 130 events) in group B, and 5·6 months (95% CI 4·8–6·8; 156 events) in group C. A significant reduction was seen in risk of progressive disease or death for patients in group B compared with group C (hazard ratio [HR] 0·55, 95% CI 0·43–0·69; p<0·0001). No significant improvement in progression-free survival was seen for group A compared with group B (HR 0·86, 0·67–1·11; p=0·25)."

P3 data • Lung Non-Squamous Non-Small Cell Cancer

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=174 ➔ 340

Enrollment change • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • DDX5

The risk of symptomatic radiation pneumonitis in small cell lung cancer patients following sequential immunochemotherapy and radiotherapy: a multicenter retrospective cohort study. (PubMed, Radiat Oncol) - "The incidence of RP2 + following sequential immunochemotherapy and RT was positively associated with male and CCRT, but negatively correlated with VO2 max in SCLC patients."

Journal • Retrospective data • Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Safety and Efficacy of Serplulimab Combined with Neoadjuvant Chemoradiotherapy in High-Risk Locally Advanced Rectal Cancer: A Retrospective Study. (PubMed, Cancer Manag Res) - "All enrolled patients received conventional radiotherapy combined with CapeOX or capecitabine monotherapy, along with serplulimab, followed by TME 8-12 weeks post-nCRT. The combination of serplulimab with nCRT demonstrated safety and efficacy in patients with high-risk pMMR LARC. However, further verification through longer follow-up periods and large-scale prospective studies is warranted."

Journal • Retrospective data • Colorectal Cancer • Fatigue • Hematological Disorders • Microsatellite Instability • Neutropenia • Oncology • Pain • Rectal Cancer • Solid Tumor • MSI

Surufatinib in Combination with Serplulimab, Etoposide, and Carboplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Preliminary Results from a Single-Arm, Phase Ia/Ib Study (ESMO-IO 2025) - P1/2 | "Subgroup analysis revealed a longer median PFS in pts without liver metastases (vs. pts with liver metastasis, 7.6 vs. 4.6 months, p=0.0821), and in pts with ≤ 2 metastatic organs (vs. pts with >2, 6.5 vs. 4.9 months, p=0.4787). Grade ≥ 3 treatment-emergent adverse events included neutropenia (47.62%), leukopenia (23.81%), and thrombocytopenia (14.29%).Conclusions The combination of surufatinib, serplulimab, and EC demonstrated promising antitumor activity and survival benefits, with manageable toxicity, as a first-line treatment for ES-SCLC, particularly in patient without liver metastases.Clinical trial identification NCT05882630.Legal entity responsible for the study Fujian Cancer Hospital and Beijing Chest Hospital."

Clinical • Combination therapy • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CSF1R • FGFR1 • FLT1

Serplulimab combined with chemotherapy as first-line therapy in small cell lung cancer patients with brain metastases: A multicenter, prospective real-world study (ESMO-IO 2025) - "Eight patients (19.1%) had grade ≥ 3 immune-related AEs.Conclusions Preliminary findings suggest that serplulimab-based therapy shows potential therapeutic benefits for SCLC with BM. Patient follow-up is continuing, and further evaluation is warranted.Legal entity responsible for the study The authors."

Clinical • Real-world • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting ➔ Active, not recruiting | Trial completion date: May 2030 ➔ Dec 2030 | Trial primary completion date: May 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor