Efbemalenograstim alfa for chemotherapy induced neutropenia: A meta-analysis and systematic review of randomized controlled trials

Efbemalenograstim alfa for chemotherapy induced neutropenia: A meta-analysis and systematic review of randomized controlled trials | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Systematic Review Efbemalenograstim alfa for chemotherapy induced neutropenia: A meta-analysis and systematic review of randomized controlled trials Samiullah Shaikh, Sidra Samad, Kinza Bakht, Arun Kumar Maloth, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7115390/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose: Chemotherapy-induced neutropenia (CIN) is a common complication that increases the risk of infection, hospitalization, and treatment delays. While granulocyte colony-stimulating factors (G-CSFs) like filgrastim and pegfilgrastim are used to reduce these risks, limitations in dosing schedules and variability remain. Efbemalenograstim alfa (F-627), a novel long-acting recombinant G-CSF, has emerged as a potential alternative. This systematic review and meta-analysis aimed to evaluate its comparative safety and efficacy against standard G-CSFs in patients undergoing chemotherapy for non-myeloid malignancies. Methods: A comprehensive literature search was conducted across six databases for randomised controlled trials (RCTs) comparing F-627 to standard G-CSFs. Data from three active-controlled trials were pooled using Review Manager (RevMan) 5.4.1, with results expressed as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. Heterogeneity was assessed using the I² statistic. Narrative synthesis was performed for the data in the placebo-controlled trial and outcomes with insufficient data for meta-analysis. Risk of bias and evidence quality were evaluated using the Cochrane RoB 2.0 tool and GRADE guidelines, respectively. Results: Four RCTs comprising 973 patients were included, with 533 receiving F-627. F-627 showed comparable efficacy to standard G-CSFs in reducing duration of Grade 4 neutropenia in cycle 1 (MD = 0.04 days; 95% CI: − 0.04 to 0.13; I² = 0%). Incidence of severe neutropenia and febrile neutropenia were also similar (RR = 1.02; 95% CI: 0.97–1.07 and RR = 1.33; 95% CI: 0.41–4.30, respectively). However, a placebo-controlled trial showed a significant reduction in neutropenia and febrile neutropenia incidence with F-627. Secondary outcomes and adverse event profiles were broadly comparable across treatment arms. Conclusion Efbemalenograstim alfa offers a comparable safety and efficacy profile to standard G-CSFs for the prevention of CIN, supporting its role as a viable therapeutic option in non-myeloid cancers. CIN F-627 G-CSF agents Febrile neutropenia Pegfilgrastim Efbemalenograstim Full Text Additional Declarations No competing interests reported. Supplementary Files OnlineSupplementaryAppendix.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7115390","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Systematic Review","associatedPublications":[],"authors":[{"id":484750428,"identity":"3e255a81-109b-4537-8313-bb31b37e8155","order_by":0,"name":"Samiullah 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trials","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"CIN, F-627, G-CSF agents, Febrile neutropenia, Pegfilgrastim, Efbemalenograstim","lastPublishedDoi":"10.21203/rs.3.rs-7115390/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7115390/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose:\u003c/h2\u003e\u003cp\u003eChemotherapy-induced neutropenia (CIN) is a common complication that increases the risk of infection, hospitalization, and treatment delays. While granulocyte colony-stimulating factors (G-CSFs) like filgrastim and pegfilgrastim are used to reduce these risks, limitations in dosing schedules and variability remain. Efbemalenograstim alfa (F-627), a novel long-acting recombinant G-CSF, has emerged as a potential alternative. This systematic review and meta-analysis aimed to evaluate its comparative safety and efficacy against standard G-CSFs in patients undergoing chemotherapy for non-myeloid malignancies.\u003c/p\u003e\u003ch2\u003eMethods:\u003c/h2\u003e\u003cp\u003eA comprehensive literature search was conducted across six databases for randomised controlled trials (RCTs) comparing F-627 to standard G-CSFs. Data from three active-controlled trials were pooled using Review Manager (RevMan) 5.4.1, with results expressed as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. Heterogeneity was assessed using the I\u0026sup2; statistic. Narrative synthesis was performed for the data in the placebo-controlled trial and outcomes with insufficient data for meta-analysis. Risk of bias and evidence quality were evaluated using the Cochrane RoB 2.0 tool and GRADE guidelines, respectively.\u003c/p\u003e\u003ch2\u003eResults:\u003c/h2\u003e\u003cp\u003eFour RCTs comprising 973 patients were included, with 533 receiving F-627. F-627 showed comparable efficacy to standard G-CSFs in reducing duration of Grade 4 neutropenia in cycle 1 (MD\u0026thinsp;=\u0026thinsp;0.04 days; 95% CI: \u0026minus;\u0026thinsp;0.04 to 0.13; I\u0026sup2; = 0%). Incidence of severe neutropenia and febrile neutropenia were also similar (RR\u0026thinsp;=\u0026thinsp;1.02; 95% CI: 0.97\u0026ndash;1.07 and RR\u0026thinsp;=\u0026thinsp;1.33; 95% CI: 0.41\u0026ndash;4.30, respectively). However, a placebo-controlled trial showed a significant reduction in neutropenia and febrile neutropenia incidence with F-627. Secondary outcomes and adverse event profiles were broadly comparable across treatment arms.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eEfbemalenograstim alfa offers a comparable safety and efficacy profile to standard G-CSFs for the prevention of CIN, supporting its role as a viable therapeutic option in non-myeloid cancers.\u003c/p\u003e","manuscriptTitle":"Efbemalenograstim alfa for chemotherapy induced neutropenia: A meta-analysis and systematic review of randomized controlled trials","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-15 05:13:14","doi":"10.21203/rs.3.rs-7115390/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d00c08b2-248d-4abe-979e-5e74abad7284","owner":[],"postedDate":"July 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-11-15T23:53:14+00:00","versionOfRecord":[],"versionCreatedAt":"2025-07-15 05:13:14","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7115390","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7115390","identity":"rs-7115390","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}