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The review critically evaluates recent clinical trial evidence, noting historically limited monotherapy efficacy, while highlighting improved outcomes with combinations such as immune checkpoint inhibitors and emerging methods to address persistent gaps.",{"@graph":14,"@context":72},[15,34,55],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/pipe-dream-to-pipeline-journey-of-cancer-vaccines-and-the-road-ahead/346513/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/pipe-dream-to-pipeline-journey-of-cancer-vaccines-and-the-road-ahead/346513.png","ImageObject",300,407,{"name":42,"@type":43},"Finn","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-09-23","2026-09-22",true,{"@type":52,"interactionType":53,"userInteractionCount":22},"InteractionCounter",{"@type":54},"ViewAction",{"@type":56,"mainEntity":57},"FAQPage",[58,64,68],{"name":59,"@type":60,"acceptedAnswer":61},"What 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\nSayali Onkar,1,2 Cansu Cimen Bozkus,1,2 Mansi Saxena,1,2,* and Nina Bhardwaj1,2,3,*  \n1Vaccine and Cell Therapy Laboratory, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA  \n2Division of Hematology Oncology, Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA  \n3Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA  \n*[Correspondence:](Correspondence: mansi.saxena@mssm.edu)[ mansi.saxena@mssm.edu](Correspondence: mansi.saxena@mssm.edu) (M.S.), [nina.bhardwaj@mssm.edu](nina.bhardwaj@mssm.edu) (N. B.) [https://doi.org/10.1016/j.xcrm.2025.102575](https://doi.org/10.1016/j.xcrm.2025.102575)  \nSUMMARY  \nOver the past decade, clinical trials of therapeutic cancer vaccines have evolved substantially in scope and design, renewing interest in this immunotherapy modality. Advances in sequencing technologies and an improved understanding of the tumor microenvironment have enabled precise targeting of tumor neoantigens, accelerating the development of personalized cancer vaccines. In this review, we critically evaluate the current landscape of cancer vaccines, particularly neoantigen-based approaches, in light of recent clinical trial data. Although cancer vaccines have historically demonstrated limited efficacy as monotherapies, growing evidence suggests enhanced clinical benefit when combined with other anti-cancer treatments, including immune checkpoint inhibitors. Drawing on these findings, we summarize key lessons from past efforts and highlight persistent knowledge gaps that limit broader clinical success. Finally, we discuss emerging strategies to overcome these challenges, with the aim of improving vaccine efficacy and facilitating the integration of cancer vaccines into standard-of-care treatment for cancer patients.  \nINTRODUCTION  \nThe discovery of vaccines that can promote robust and longlasting immune responses against a host of infectious diseases has proven to be a turning point in the story of human survival. The leap from vaccination against infectious diseases to treating cancer was first made by Dr. Coley over a century ago through the use of a cocktail of inactivated bacteria, widely known as Coley’s toxins, to elicit an anti-tumor response.1 Since then, for decades, cancer vaccines, designed to augment immune recognition and targeting of tumor antigens, have been the subject of active and intensive investigation. The primary goal of a cancer vaccine is to initiate a cascade of immune activation events leading to the priming of antigen-specific T cells, which can then mount effective tumor control and potentially generate longterm memory.2 ,3 In the past, numerous cancer-targeted vaccine approaches have been tested in early-phase clinical studies. Yet, only one vaccine called sipuleucel-T (Sip-T), an autologous cellular vaccine targeting prostatic acid phosphatase (PAP) inpatients with metastatic prostate cancer, has received Food and Drug Administration (FDA) approval. However, despite getting FDA approval, Sip-T failed to induce long-lasting clinical benefits.4 Other antigen-agnostic immune-modulating agents, namely, talimogene laherparepvec (T-VEC), an oncolytic virus delivered intratumorally in patients with unresectable melanoma, and Bacillus Calmette-Gu´erin (BCG), a live attenuated strain of Mycobacterium bovis injected directly into the bladder of patients with non-muscle invasive bladder cancer, are also  \ncurrently approved by the FDA. Despite indications of immunogenicity, with the exception of BCG, these therapies induce only a modest overall survival (OS) (4 months with Sip-T) and progression-free survival (PFS) benefit (29 .5% with T-VEC) .4 ,5  \nIn contrast, over the last 15 years, immunotherapy with immune checkpoint inhibitors (ICI) has led to impressive complete responses in various types of hematolog","cbCaigfpfkcErM4K","https://ap.wps.com/l/cbCaigfpfkcErM4K","pdf",4001801,18,"English","# Factors Impacting Cancer Vaccine Efficacy: TME Components and Immune Resistance\n## Cancer immunity cycle and vaccine design principles","[{\"question\":\"What major technological and biological advances are driving progress in cancer vaccines?\",\"answer\":\"Advances in sequencing technologies and a clearer understanding of the tumor microenvironment support more precise targeting of tumor neoantigens and improved vaccine design.\"},{\"question\":\"Why have cancer vaccines often shown limited efficacy when used alone?\",\"answer\":\"Historically, cancer vaccines as monotherapies have demonstrated limited overall efficacy, even though they can promote immune activation.\"},{\"question\":\"How can cancer vaccines potentially improve patient outcomes when combined with other therapies?\",\"answer\":\"Combining cancer vaccines with immune checkpoint inhibitors and other modalities may enhance clinical benefit, including by augmenting and prolonging responses that ICIs alone cannot universally achieve.\"}]","Pipe dream to pipeline - Journey of cancer vaccines and the road ahead | PDF",1790061755,45]