Efficacy and safety of serplulimab in solid tumors: a meta-analysis

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...

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Main Authors: Peimeng Shen, Tao Zhang, Lina Hao, Ming Jing, Yanxin Wu, Shuwen Yu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1604874/full
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author Peimeng Shen
Peimeng Shen
Tao Zhang
Lina Hao
Ming Jing
Yanxin Wu
Shuwen Yu
Shuwen Yu
Shuwen Yu
author_facet Peimeng Shen
Peimeng Shen
Tao Zhang
Lina Hao
Ming Jing
Yanxin Wu
Shuwen Yu
Shuwen Yu
Shuwen Yu
author_sort Peimeng Shen
collection DOAJ
description 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.
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spelling doaj-art-306c0938b57349ffa86f8cd0eac9d5eb2025-08-20T02:35:51ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-06-011610.3389/fphar.2025.16048741604874Efficacy and safety of serplulimab in solid tumors: a meta-analysisPeimeng Shen0Peimeng Shen1Tao Zhang2Lina Hao3Ming Jing4Yanxin Wu5Shuwen Yu6Shuwen Yu7Shuwen Yu8School of Pharmaceutical Sciences, Shandong University, Jinan, Shandong, ChinaDepartment of Pharmacy, Shandong Electric Power Central Hospital, Jinan, Shandong, ChinaDepartment of Pharmacy, Shandong Electric Power Central Hospital, Jinan, Shandong, ChinaDepartment of Pharmacy, Children’s Hospital Affiliated to Shandong University, Jinan, Shandong, ChinaDepartment of Pharmacy, Shandong Electric Power Central Hospital, Jinan, Shandong, ChinaDepartment of Pharmacy, Shandong Electric Power Central Hospital, Jinan, Shandong, ChinaSchool of Pharmaceutical Sciences, Shandong University, Jinan, Shandong, ChinaPhase I Clinical Trial Center, Qilu Hospital of Shandong University, Jinan, Shandong, ChinaNMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, Shandong University, Jinan, Shandong, ChinaObjectiveThe 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.https://www.frontiersin.org/articles/10.3389/fphar.2025.1604874/fullsafetymeta-analysissolid tumorsserplulimabefficacy
spellingShingle Peimeng Shen
Peimeng Shen
Tao Zhang
Lina Hao
Ming Jing
Yanxin Wu
Shuwen Yu
Shuwen Yu
Shuwen Yu
Efficacy and safety of serplulimab in solid tumors: a meta-analysis
Frontiers in Pharmacology
safety
meta-analysis
solid tumors
serplulimab
efficacy
title Efficacy and safety of serplulimab in solid tumors: a meta-analysis
title_full Efficacy and safety of serplulimab in solid tumors: a meta-analysis
title_fullStr Efficacy and safety of serplulimab in solid tumors: a meta-analysis
title_full_unstemmed Efficacy and safety of serplulimab in solid tumors: a meta-analysis
title_short Efficacy and safety of serplulimab in solid tumors: a meta-analysis
title_sort efficacy and safety of serplulimab in solid tumors a meta analysis
topic safety
meta-analysis
solid tumors
serplulimab
efficacy
url https://www.frontiersin.org/articles/10.3389/fphar.2025.1604874/full
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