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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Frontiers Media S.A.
2025-06-01
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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 |
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| 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. |
| format | Article |
| id | doaj-art-306c0938b57349ffa86f8cd0eac9d5eb |
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| issn | 1663-9812 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| 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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