Serplulimab 100mg/10ml solution for infusion vials

BackgroundCombination regimens of immunotherapy plus chemotherapy have been approved as the first-line and standard of care for extensive-stage small cell lung cancer (ES-SCLC). Novel regimens are continuously being explored, with the ETER701 study being the representative randomized controlled trial (RCT). ETER701 study has assessed the efficacy and safety of chemotherapy with or without anlotinib (multi-target angiogenesis inhibitor) + benmelstobart (programmed cell death ligand 1 inhibitor) (Anl/Ben/CT). There is no evidence-based medicine available proving that Anl/Ben/CT is the optimal regimen due to the lack of direct or indirect comparisons among varying immunotherapy-based regimens. In this study, we aimed to identify the optimal regimen to assist in clinical decision-making.MethodsThe eligible RCTs were identified by searching PubMed, Embase, Cochrane Library databases, and major international conferences. Then, the network meta-analysis was analyzed to compare the efficacy and safety among 15 first-line regimens in ES-SCLC. The Cochrane Risk of Bias Tool was used to assess the risk of bias in included studies.ResultsA total of 12 immunotherapy-related RCTs covering 15 interventions and 6,178 patients with ES-SCLC were included. Overall, most RCTs exhibited a low risk of bias across multiple domains. The results indicated that most immunotherapy-based regimens could significantly prolong progression-free survival (PFS) compared with chemotherapy alone, especially Anl/Ben/CT [hazard ratio (HR) 0.32, 95% confidence interval (CI): 0.25-0.40]. Similar results were observed regarding overall survival (OS), that is, most immunotherapy-related regimens dramatically reduced the risk of death in ES-SCLC, with Anl/Ben/CT being the most prominent (HR 0.61, 95% CI: 0.47-0.80). The Bayesian ranking probabilities showed that Anl/Ben/CT ranked first and serplulimab plus chemotherapy ranked second in both PFS and OS among 15 regimens. Regarding safety, Anl/Ben/CT ranked 3rd, and serplulimab plus chemotherapy ranked 7th.ConclusionsAdding anlotinib and benmelstobart to chemotherapy significantly improved PFS and OS compared with chemotherapy alone or chemotherapy plus immunotherapy, with an acceptable safety profile in patients with ES-SCLC. In conclusion, Anl/Ben/CT could be a new, preferable first-line treatment option but further clinical studies are needed to validate its efficacy and safety.

Abstract licence: CC BY-NC-ND

Yi Zhu, Xiao Qi, Senmiao Ni, Wenting Qiu, Mengkai Chen Department of Biostatistics, Shanghai Henlius Biotech, Inc., Shanghai, People’s Republic of ChinaCorrespondence: Mengkai Chen, Department of Biostatistics, Shanghai Henlius Biotech, Inc., 188 Yizhou Road, Shanghai, 200233, People’s Republic of China, Tel +86-156-5172-5532, Email mengkai_chen@henlius.comPurpose: Blockade of the PD-L1/PD-1 pathway combined with chemotherapy has demonstrated significant survival benefits as first‑line therapy for esophageal squamous cell carcinoma (ESCC). However, comprehensive benefit-risk comparisons among approved agents remain limited. This study conducted an indirect comparison of serplulimab versus other anti-PD-1/PD-L1 antibodies plus chemotherapy in treatment-naïve ESCC patients.Patients and Methods: A systematic review with matching-adjusted indirect comparisons (MAICs) was conducted using individual patient data (IPD) from ASTRUM-007 and aggregate data (AgD) from seven comparator trials, including CheckMate 648, ESCORT-1st, GEMSTONE-304, JUPITER-06, KEYNOTE-590, ORIENT-15, and RATIONALE-306. IPD were reweighted to match key baseline characteristics. Hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) were estimated using the Bucher method. Subgroup analyses were further explored using Bayesian network meta-analysis.Results: Eight Phase 3 randomized controlled trials comprising 4,702 patients were included. After adjusting for baseline imbalances, serplulimab demonstrated comparable efficacy to other PD-1/PD-L1 inhibitors. The pooled adjusted OS HR was 0.98 (95% CI, 0.87– 1.11), with numerically favorable OS versus nivolumab (HR, 0.76; 95% CI 0.47– 1.24) and comparable OS versus pembrolizumab (HR, 0.93; 95% CI, 0.71– 1.22) and camrelizumab (HR, 0.93; 95% CI, 0.70– 1.24). The pooled adjusted PFS HR was 0.91 (95% CI, 0.81– 1.02), significantly favoring serplulimab over nivolumab (HR, 0.56; 95% CI, 0.33– 0.96), with favorable trends versus pembrolizumab (HR, 0.83; 95% CI, 0.63– 1.10) and sugemalimab (HR, 0.86; 95% CI, 0.63– 1.16). Subgroup analyses suggested greater relative benefit in women and patients with locally advanced disease. Grade 3– 5 treatment-related adverse events occurred in 52.9% of serplulimab-treated patients, comparable to other PD-1/PD-L1 inhibitors (range, 47.4%-71.9%).Conclusion: This indirect comparison provides comparative benefit-risk evidence to inform first‑line treatment selection for locally advanced or metastatic ESCC. Serplulimab plus chemotherapy demonstrated a clinically meaningful PFS benefit, comparable OS after matching, and a manageable safety profile consistent with the PD-1/PD-L1 inhibitor class.Keywords: matching-adjusted indirect comparison, immune checkpoint inhibitor, esophageal neoplasms, benefit-risk assessment, first-line therapy

Abstract licence: CC BY-NC 3.0

Cancer immunotherapy with immune checkpoint inhibitors (ICIs) has transformed oncologic treatment, yet hematological adverse events (HAEs) remain incompletely characterized across different agents. We conducted a systematic review and network meta-analysis to compare the incidence and risk of hematological toxicities (all grades) among various ICIs. A comprehensive literature search was performed across PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science through January 2026. Phase II and III randomized controlled trials (RCTs) evaluating ICIs and reporting HAEs were included. Frequentist network meta-analysis was performed to estimate odds ratios and rankings using surface under the cumulative ranking curve values for anemia, neutropenia, and thrombocytopenia. Thirty-seven RCTs encompassing diverse malignancies were included in the network meta-analysis. For anemia, ipilimumab demonstrated the most favorable safety profile, followed by toripalimab and pembrolizumab, while serplulimab and nivolumab ranked lowest. Regarding neutropenia, ipilimumab again showed the best safety ranking, followed by avelumab and pembrolizumab, whereas toripalimab and serplulimab exhibited less favorable profiles. For thrombocytopenia, ipilimumab ranked highest, followed by sintilimab and nivolumab, while toripalimab showed the least favorable ranking. No significant global inconsistency was detected across networks. Publication bias was identified for neutropenia but not for anemia or thrombocytopenia. This network meta-analysis reveals substantial heterogeneity in hematological safety profiles across ICIs, with ipilimumab consistently demonstrating favorable rankings across all HAEs. These findings suggest potential differences in hematologic safety profiles across treatments. However, given the star-shaped network structure, reliance on indirect comparisons, and observed heterogeneity, the results should be interpreted cautiously. While not definitive, the analysis may still offer preliminary insights to inform treatment selection, particularly for patients with baseline hematological vulnerabilities or those receiving concurrent myelosuppressive therapies, and may help guide the development of risk-stratified monitoring strategies in clinical practice.

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BackgroundFor advanced non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) expression MethodsPubMed, Ovid Medline, the Cochrane Library, and Embase were searched from database inception to August 15, 2025, to identify phase III randomized controlled trials (RCTs) that explored first-line treatments in treatment-naïve advanced NSCLC, PD-L1 ResultsTwenty-five phase III RCTs involving 5,815 participants were eligible. Overall, 21 first-line treatments were identified. 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. Nivolumab + ipilimumab (Nivo-ipi) (SUCRA =0.78) closely followed. Both top regimens showed non-significant superiority over Pembro-chemo. Regarding PFS, nivolumab + chemotherapy + bevacizumab (SUCRA =0.88), and serplulimab + chemotherapy (SUCRA =0.87) were the optimal regimens. Specifically for non-squamous patients, Pembro-chemo was optimal for OS (SUCRA =0.90), followed by Nivolumab + chemotherapy + bevacizumab (SUCRA =0.82). Nivolumab + chemotherapy + bevacizumab optimized PFS, with an hazard ratio (HR) of 0.52 [95% confidence interval (CI): 0.30-0.92 vs. Pembro-chemo]. For squamous patients, nivolumab + ipilimumab ± chemotherapy (Nivo-ipi-chemo) led in OS, while serplulimab + chemotherapy in PFS.ConclusionsFirst-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.

Abstract licence: CC BY-NC-ND

Objective The ASTRUM-005 trial showed that serplulimab plus chemotherapy (SEP) significantly extended survival time compared with chemotherapy in the treatment of small cell lung cancer. But the survival benefits of SEP came at high costs, and its economy is not clear. Therefore, this study aimed to evaluate the cost-effectiveness of SEP from the perspective of the Chinese healthcare system. Design A partition survival model was built to simulate the outcomes. The clinical data came from the ASTRUM-005 trial, and only direct medical costs were included in the model. The utility values referred to the published literature. Scenario analyses 1 and 2 explored outcomes in the presence of a patient assistance plan (PAP) and different simulation periods, respectively. Scenario analysis 3 compared the cost-effectiveness of atezolizumab plus chemotherapy (AEP) with SEP by network meta-analysis. Sensitivity analyses were conducted to assess the robustness of the results. Outcome measures Total costs, incremental costs, life years, quality-adjusted life years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER). Results Compared with chemotherapy, SEP achieved an additional 0.34 QALYs at incremental costs of US$41 682.63, with an ICER of US$122 378.86/QALY. When PAP was available, ICER was US$58 316.46/QALY. In the simulation time of 5 years and 20 years, the ICER was US$132 637.97/QALY and US$118 054.59/QALY, respectively. When compared with AEP, SEP not only reduced the costs by US$47 244.87 but also gained 0.07 QALYs more. Sensitivity analyses showed that the price of serplulimab and the utility value of the progression-free survival stage were the main influencing parameters, and the results were stable. Conclusions Compared with chemotherapy, SEP was not cost-effective from the perspective of the Chinese healthcare system. However, SEP was absolutely dominant in comparison with AEP.

Abstract licence: CC BY-NC 4.0

ObjectiveThe goal of this study was to investigate the effectiveness and safety of serplulimab in advanced solid tumors through a meta-analysis approach.MethodsAn electronic search was conducted across the Embase, Web of Science, PubMed, and Cochrane Library databases, covering the period from each database’s inception through 6 May 2025. Meta-analysis and related analyses, including subgroup, sensitivity, and publication bias assessments, were performed using Stata 16.0. The Cochrane Risk of Bias Assessment Tool (version 5.1.0) was utilized to measure the quality of randomized controlled trials (RCTs). For single-arm studies, quality was evaluated using the Methodological Index for Non-Randomized Studies (MINORS).ResultsTen studies, including three RCTs and seven single-arm studies, were analyzed, involving 2,020 patients. In the analysis of RCTs, serplulimab significantly elevated overall survival (OS) [HR = 0.68, 95% CI: 0.59–0.79, P < 0.01], disease control rate (DCR) [RR = 1.04, 95% CI: 1.01–1.08, P < 0.05], progression-free survival (PFS) [HR = 0.53, 95% CI: 0.47–0.61, P < 0.01], and objective response rate (ORR) [RR = 1.30, 95% CI: 1.09–1.56, P < 0.01]. The analysis of single-arm studies revealed that the ORR for serplulimab in solid tumors was [ES = 45%, 95% CI: 31%–59%, P < 0.01], and the DCR was [ES = 71%, 95% CI: 63%–80%, P < 0.01]. Among the ten studies, the most common adverse events included reductions in platelet count (0.32, 95% CI: 0.20–0.43), white blood cell count (0.30, 95% CI: 0.17–0.44), anemia (0.29, 95% CI: 0.09–0.48), and proteinuria (0.28, 95% CI: 0.17–0.38).ConclusionBased on current research, serplulimab appears to be effective for solid tumors. However, given the limitations of the studies, for example, possible selection bias in single-arm studies, further multicenter, high-quality, large-sample RCTs are necessary to validate this conclusion.

Abstract licence: CC BY 4.0