Immunotherapy最新文献

{"title":"Prognostic factors in avelumab maintenance therapy for metastatic urothelial carcinoma.","authors":"Caner Kapar, Oğuzcan Özkan, Eda Eylemer Mocan, Sendag Yaslikaya, Ali Murat Tatlı, Goncagül Akdağ, Hacer Demir, Irem Bilgetekin, Kaan Helvacı, Fatih Selcukbiricik, Fatih Köse, Murat Sari, Gökmen Umut Erdem, Zehra Sucuoğlu İşleyen, Cagatay Arslan, Sinemis Celik, Türkkan Evrensel, Bekir Mert Durukan, Seher Nazli Kazaz, Banu Ozturk, Halil Çelik, Miraç Özen, Pınar Erel, Pervin Can Şancı, Yakup Ergün, Hakan Taban, Ömer Faruk Kuzu, Burcu Ulaş Kahya, Ahmet Melih Arslan, Abdullah Sakin, Murat Araz, Kerem Okutur, Fahri Akgül, Cem Mirili, Alper Sevinç, Fatih Atalah, Yakup Düzköprü, Burcu Gülbağcı, Nurten Kandemir, Hakan Kosku, Esra Aydın, Dilek Erdem, Murad Guliyev, Mesut Yılmaz, Yaşar Çulha, Berksoy Şahin, Pınar Gürsoy, Mustafa Erman, Yüksel Ürün, Deniz Tural","doi":"10.1080/1750743X.2026.2722548","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2722548","url":null,"abstract":"<p><strong>Background: </strong>In the present study, we evaluated pretreatment prognostic factors for overall survival in patients with metastatic urothelial carcinoma who received maintenance avelumab within the Expanded-Access Program.</p><p><strong>Patients and methods: </strong>We retrospectively analyzed 132 patients with metastatic urothelial carcinoma who received at least one cycle of avelumab. Overall survival (OS) was estimated using the Kaplan-Meier method. Univariate analysis was performed to identify pretreatment prognostic factors associated with OS (<i>p</i> < 0.05), and significant variables were included in a multivariate Cox model.</p><p><strong>Results: </strong>Median age was 67 years (range, 43-84) and the bladder was the primary tumor site in 78% of patients. Visceral metastases were present in 62.5% of patients, and 32% had lymph node-only disease. ECOG ≥ 1 was observed in 59.1%, and 57% received cisplatin-based chemotherapy. The median follow-up was 24 months, the median OS was 23.8 months, and the 24-month OS rate was 47% (95% CI, 35%-55%).In univariate analysis, liver metastases, bone metastases, and hemoglobin < 10 g/dL were significantly associated with OS. In multivariate analysis, bone metastases (HR = 2.3; 95% CI 1.3-5; <i>p</i> = 0.008) and hemoglobin < 10 g/dL (HR = 2.6; 95% CI 1.2-4.1; <i>p</i> = 0.004) remained independent predictors of worse OS.</p><p><strong>Conclusions: </strong>Bone metastases and low hemoglobin are independent predictors of poor survival in patients receiving maintenance avelumab, supporting their role in risk stratification.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-7"},"PeriodicalIF":2.3,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148874206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Low-dose interleukin-2 combined with thalidomide for a severe cutaneous immune-related adverse event associated with PD-1/CTLA-4 bispecific antibody therapy: a case report.","authors":"Zhiqiang Li, Yufei Li, Yuhan Zhang, Qiuxia Ye, Jing He, Mingwei Li","doi":"10.1080/1750743X.2026.2722556","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2722556","url":null,"abstract":"<p><p>Immune checkpoint inhibitors (ICIs), including novel bispecific antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), have expanded therapeutic options but have also increased the incidence and complexity of immune-related adverse events (irAEs). Low-dose interleukin-2 (Ld-IL2) has been explored as a potential immunomodulatory strategy. However, its role in real-world combination regimens for managing severe cutaneous irAEs remains to be fully elucidated. We report the case of a patient with gastric cancer who developed rapidly progressive erythema and pruritus after treatment with iparomlimab and tuvonralimab. Symptoms worsened despite corticosteroids, intravenous immunoglobulin (IVIG) and antihistamines. After Ld-IL2 and thalidomide were added while corticosteroid treatment was continued, clinical improvement was observed within 48 hours, with complete resolution of the skin lesions at 2 weeks. Because Ld-IL2, thalidomide, and corticosteroids were administered concurrently, the independent contribution of each treatment and the underlying immunological mechanism could not be determined. However, further studies are warranted to clarify the potential value of this combined regimen in the management of such adverse events.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-7"},"PeriodicalIF":2.3,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148812872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of PARP inhibitor and immune checkpoint inhibitor combination therapy in PD-L1-negative cancers: a systematic review and meta-analysis.","authors":"Susu Zhou, Vishw Patel, Noriko Kishi, Komal Akhtar, Che-Kai Tsao","doi":"10.1080/1750743X.2026.2722581","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2722581","url":null,"abstract":"<p><strong>Introduction: </strong>Poly (ADP-ribose) polymerase inhibitors (PARPis) can enhance antitumor immunity and improve the efficacy of immune checkpoint inhibitors (ICIs) through PD-L1 upregulation and STING pathway activation. However, the benefit of this combination in PD-L1-negative patients remains unclear.</p><p><strong>Methods: </strong>We conducted a systematic review and meta-analysis of 22 clinical trials including 1,849 patients, of whom 718 were PD-L1-negative. Pooled objective response rate (ORR), disease control rate (DCR) and 12-month progression-free survival (12-m PFS) were estimated using a random-effects model. Subgroup analyses were conducted by BRCA mutation, homologous recombination deficiency (HRD), and cancer type.</p><p><strong>Results: </strong>PD-L1-negative patients had a lower ORR than PD-L1-positive patients (21% vs. 36%; <i>p</i> = 0.046). However, BRCA-mutated tumors demonstrated high ORRs irrespective of PD-L1 status (67% vs. 73%; <i>p</i> = 0.643), with a similar trend in HRD-positive tumors. The impact of PD-L1 varied by tumor type: reduced activity was observed in breast cancer, whereas ovarian cancer maintained meaningful responses regardless of PD-L1 expression. Responses were limited in other tumor types. DCR and 12-m PFS were numerically lower in PD-L1-negative patients without statistical significance.</p><p><strong>Conclusions: </strong>HRD/BRCA-driven genomic instability appears to play a dominant role in treatment response, suggesting that PD-L1 negativity alone should not preclude use of this combination.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD420251163119.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-11"},"PeriodicalIF":2.3,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148812900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Injection-based safety of aqueous venom immunotherapy during venom extract shortage: impact of forced depot-to-aqueous switching.","authors":"Gökten Bulut, Rukiye Demiralp, Şefika Karabaş, Fidan Coşkun","doi":"10.1080/1750743X.2026.2722552","DOIUrl":"https://doi.org/10.1080/1750743X.2026.2722552","url":null,"abstract":"<p><strong>Background: </strong>Venom immunotherapy (VIT) is the only disease-modifying treatment for Hymenoptera venom allergy. Nationwide shortages of depot venom extracts necessitated transition to aqueous preparations, but real-world safety data on this switch remain limited.</p><p><strong>Objective: </strong>To evaluate the injection-based safety of aqueous VIT and the impact of forced depot-to-aqueous switching on systemic reactions (SRs).</p><p><strong>Methods: </strong>This retrospective single-center cohort included 31 aqueous VIT courses in 30 adults treated between January 2023 and January 2026. Patients initiated aqueous VIT or were compulsorily switched from depot preparations. SRs were assessed at treatment-course and injection levels. Predictors were evaluated using Firth penalized logistic regression.</p><p><strong>Results: </strong>SRs occurred in 10/31 courses (32.3%) and in 28/504 injections (5.6%): 6.3% during buildup and 4.6% during maintenance. Most were mild to moderate, with no Grade 4-5 reactions. Comorbid disease independently predicted SRs (adjusted OR 5.87, 95% CI 1.07-38.42; <i>p</i> = 0.042). Forced switching showed higher odds of SRs but was not independently significant (adjusted OR 6.84, 95% CI 0.84-88.76; <i>p</i> = 0.072).</p><p><strong>Conclusions: </strong>Aqueous VIT remained feasible during the depot extract shortage despite a higher-than-previously-reported SR rate. Comorbid disease predicted SRs, while forced switching may identify patients requiring closer monitoring.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-9"},"PeriodicalIF":2.3,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness analysis of Nivolumab plus Ipilimumab versus Nivolumab monotherapy in previously treated metastatic colorectal cancer patients with DNA mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) in China.","authors":"Xiaohong Zhu, Xu Yang, Tong Liu","doi":"10.1080/1750743X.2026.2715931","DOIUrl":"10.1080/1750743X.2026.2715931","url":null,"abstract":"<p><strong>Aims: </strong>This study evaluated the cost-effectiveness of Nivolumab plus Ipilimumab versus Nivolumab monotherapy in previously treated metastatic colorectal cancer (CRC) patients with DNA mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) in China.</p><p><strong>Materials and methods: </strong>An economic evaluation using a three-state partitioned survival model assessed the cost-effectiveness of Nivolumab plus Ipilimumab versus Nivolumab monotherapy. The Kaplan-Meier curves for overall survival and progression-free survival from a clinical trial were digitally extracted, and the Weibull model was applied to extrapolate long-term survival.</p><p><strong>Results: </strong>The anticipated cost and utility of the Nivolumab plus Ipilimumab arm exceeded those of the Nivolumab monotherapy arm, respectively (322,575.67 USD vs. 188,409.23 USD; 3.88 QALYs vs. 2.57 QALYs). The ICER was 102,646.86 USD/QALY, suggesting that Nivolumab plus Ipilimumab was not cost-effective compared to Nivolumab monotherapy as the late-line treatment for metastatic CRC patients with dMMR/MSI-H.</p><p><strong>Conclusions: </strong>Nivolumab plus Ipilimumab was not cost-effective compared to Nivolumab monotherapy in previously treated metastatic CRC patients with dMMR/MSI-H in China.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"835-845"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148706366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and tolerability of a new intravenous immunoglobulin 10% in patients with primary immunodeficiency.","authors":"Roberto Crea, Elena Perez, Chaim M Roifman","doi":"10.1080/1750743X.2026.2706964","DOIUrl":"10.1080/1750743X.2026.2706964","url":null,"abstract":"<p><strong>Aims: </strong>Kedrion IVIg 10% (KIg10; QIVIGY) is a new, ready-to-use, 10% liquid IVIg (100 mg/mL) approved for adults with primary immunodeficiency (PI). This report presents safety and tolerability data from a phase III study.</p><p><strong>Methods: </strong>This was an open-label, prospective, single-arm, historically controlled, multicenter study in adults with confirmed PI receiving commercially available IVIg products. Participants received KIg10 200-800 mg/kg once every 21 or 28 days for 17 and 13 infusions, respectively.</p><p><strong>Results: </strong>Forty-seven participants received KIg10 every 21 days (<i>n</i> = 8) or every 28 days (<i>n</i> = 39). Overall, 97.9% (<i>n</i> = 46) of participants had treatment-emergent adverse events (TEAEs) and 46.8% (<i>n</i> = 22) experienced drug-related TEAEs; most were mild or moderate. Across 80 infusions, 122 infusional AEs occurred in 30 participants (63.8%); infusional AEs decreased with later versus initial infusions. No life-threatening TEAEs, deaths, serious or severe drug-related TEAEs, thrombotic events, or occurrences of aseptic meningitis, transfusion-related acute lung injury, acute renal failure, or neutropenia were observed. A drug-related hypersensitivity event (skin reaction) occurred in 1 participant. Forty-four (93.6%) participants reached the maximum dose rate (8 mg/kg/min).</p><p><strong>Conclusion: </strong>KIg10 was well tolerated in adults with PI, supporting its use as a replacement therapy option in this population.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"825-833"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148684377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lupus nephritis treatment: a comprehensive overview of recent meta-analyses and future directions.","authors":"Feigao Li, Xizhe Liu, Bokun Chen, Menghao Li, Xiuju Liu","doi":"10.1080/1750743X.2026.2705727","DOIUrl":"10.1080/1750743X.2026.2705727","url":null,"abstract":"<p><strong>Introduction: </strong>This review summarizes recent findings from meta-analyses on lupus nephritis (LN) therapies to promote precision medicine and address the challenge of fragmented evidence.</p><p><strong>Methods: </strong>A literature search identified 34 relevant meta-analyses published between January 2021 and March 2025.</p><p><strong>Results: </strong>Key findings include: Biological agents, particularly Belimumab and Obinutuzumab, significantly improve complete renal remission (CR) and reduce the risk of end-stage renal disease, breaking through traditional therapeutic bottlenecks. However, rituximab, while effective, carries a higher infection risk (SUCRA = 74.98%). The combination of tacrolimus and mycophenolate mofetil doubled the CR rate compared to monotherapy (OR = 2.85), but requires monitoring for creatinine elevation. Voclosporin use is limited by a high infection risk. The combination of Tripterygium glycosides and Western medicine increased the CR rate by 61% (RR = 1.61), while Astragalus-containing Chinese herbal medicine significantly reduced proteinuria (SMD = 0.51), highlighting the value of traditional Chinese medicine in enhancing efficacy and reducing toxicity. Glucocorticoid therapy presents a critical trade-off: an initial dose >60 mg/day improves CR to 34.6% but elevates severe infection and mortality rates to 12.1% and 2.7%, respectively, underscoring the urgent need for dose precision. In diagnostics, urinary TWEAK demonstrates high specificity. Mesenchymal stem cell therapy achieved a 33.7% remission rate.</p><p><strong>Conclusion: </strong>In conclusion, this review provides a comprehensive overview of recent research on LN treatment, offering evidence-based support for clinical decision-making and points out directions for future research.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"847-862"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148497469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of immunotherapy in the treatment of early-stage non-small lung cancer, melanoma, and colorectal cancer.","authors":"Alfredo Tartarone, Raffaele Conca, Alessandra Perrone, Rosa Lerose","doi":"10.1080/1750743X.2026.2721165","DOIUrl":"10.1080/1750743X.2026.2721165","url":null,"abstract":"<p><p>In recent years, immunotherapy (I-O), following the introduction into clinical practice of several immune checkpoint inhibitors (ICIs), has revolutionized the treatment landscape of many types of cancer. To date, different ICIs, administered either as monotherapy or in combination with other agents, have been approved or are currently being tested for the treatment of more than 20 different cancer types, mainly in the metastatic setting. More recently, driven by the results achieved in advanced disease, I-O has expanded into the treatment of various tumors at earlier stages, showing promising results also in this context. I-O‑based combination regimens could be particularly effective in early-stage cancer due to different reasons such as the presence of a less immunosuppressive microenvironment, a more intact lymphatic-vascular architecture, a better T-cell fitness, a less tumor heterogeneity and resistance. We reviewed the role of I-O in early-stage non-small cell lung cancer, colorectal cancer, and melanoma with the aim of highlighting the potential advantages of I-O administration in this clinical setting. A comprehensive literature search was conducted using PubMed, Embase, and Web of Science for English language peer-reviewed articles published until June 2026.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"871-881"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoantigen in cancer immunotherapy: mechanism, therapeutic strategies and future perspectives.","authors":"Aditya Raj, Zuber Khan, Mumtaz, Sidharth Mehan, Tapan Lamba, Niyati Pandoh, Keerti Dayal","doi":"10.1080/1750743X.2026.2721185","DOIUrl":"10.1080/1750743X.2026.2721185","url":null,"abstract":"<p><p>Neoantigens are tumor-specific antigens resulting from genetic, transcriptomic, and proteomic changes, making them a promising avenue for personalized cancer immunotherapy due to their unique specificity and strong immunogenicity. They arise through various mechanisms like SNVs, INDELs, SVs, alternative splicing, post-translational modifications, and viral oncoproteins. Neoantigen-based therapies, including personalized vaccines, adoptive T-cell therapies, and immune checkpoint inhibitors, have demonstrated considerable potential in both preclinical and clinical settings. Tumors with high mutational burdens, like melanoma and lung cancers, show significant neoantigen-driven immune responses. Progress in cancer treatment is highlighted by the need for combinatorial approaches in tumors with low neoantigen loads, such as pancreatic and prostate cancers, to boost immunogenicity. Advances in computational tools and next-generation sequencing support accurate neoantigen identification for personalized therapies. However, challenges remain, including tumor heterogeneity and immune evasion. Innovative solutions such as machine learning for neoantigen prediction and the use of lipid nanoparticles, alongside radiotherapy and chemotherapy, are being developed to overcome these limitations. Future strategies may involve integrating multi-omics data, next-generation vaccines, and CRISPR-Cas9 gene editing technologies to enhance therapeutic precision. Overall, despite existing challenges, neoantigen-targeted immunotherapies hold promise for advancing precision oncology and improving patient outcomes.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"883-908"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of artificial intelligence in predicting immunotherapy treatment outcomes based on gut microbiota composition in cancer patients: a meta-analysis.","authors":"Leen Alhassan, Bassel Alrabadi, Suhel F Batarseh, Yousef Alghzawi, Natalie Bandak, Aseel Badwan, Hadeel Al Kayed","doi":"10.1080/1750743X.2026.2717074","DOIUrl":"10.1080/1750743X.2026.2717074","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) have transformed cancer treatment, but response varies across patients. Gut microbiota may influence immunotherapy outcomes, while artificial intelligence (AI) can help characterize complex microbiome-host interactions. This systematic review and meta-analysis evaluated AI models for predicting immunotherapy outcomes using gut microbiota data.</p><p><strong>Methods: </strong>PubMed, Scopus, and Cochrane Library were searched through January 2025. The primary outcome was pooled area under the curve (AUC).</p><p><strong>Results: </strong>Nine studies were included in the systematic review, with eight eligible for meta-analysis. The pooled AUC was 0.85 (95% CI: 0.78-0.91), indicating strong predictive performance. Several studies identified microbial taxa, including <i>Bacteroides</i> and <i>Porphyromonadaceae</i>, associated with treatment outcomes.</p><p><strong>Conclusion: </strong>AI-based models show promising potential for predicting immunotherapy response using gut microbiota data. However, limited evidence, substantial methodological heterogeneity, and restricted patient populations limit the reliability and generalizability of current estimates. Larger multicenter studies with standardized AI pipelines and external validation are needed before clinical implementation.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"863-870"},"PeriodicalIF":2.3,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}