{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T06:25:32Z","timestamp":1787034332726,"version":"build-2736575974"},"reference-count":28,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cadonilimab, a bispecific PD-1\/CTLA-4 antibody, has activity in recurrent\/metastatic cervical cancer (R\/M CC), but high costs limit accessibility, especially in low- and middle-income countries. Hence, we aimed to assess whether lower dose of cadonilimab may achieve comparable clinical outcomes with improved tolerability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This retrospective real-world study evaluated 137 R\/M CC patients treated with cadonilimab 6mg\/kg every three weeks as first-line therapy at Sichuan Cancer center from January 1, 2023, to September 30, 2025. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 133 efficacy-evaluable patients, the ORR was 55.6%, consisting of complete and partial responses in 10.5% and 45.1% of patients, respectively. The DCR was 83.5%. In patients aged \u226565 years, the ORR and DCR were 47.8% and 87.0%, respectively. The 12-month OS rate was 92.1% (95% CI, 86.5%-98.0%), and the 12-month PFS rate was 67.3% (95% CI, 58.4%-77.4%). Grade \u22653 treatment-related adverse events occurred in 78.8% and the most common were neutropenia, anemia, and lymphopenia. While immune-related adverse events were observed in 35.0% of patients, severe events were rare, occurring in only 3.6%. Furthermore, clinical outcomes and safety profiles were comparable across different chemotherapy regimens.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Low-dose cadonilimab demonstrates robust efficacy and manageable safety in R\/M CC, with encouraging outcomes in elderly patients. Prospective randomized trials are needed to validate the efficacy of dose-reduced strategies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1871890","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:38:12Z","timestamp":1787031492000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world efficacy and safety profile of low-dose cadonilimab in recurrent or metastatic cervical cancer as first-line therapy"],"prefix":"10.3389","volume":"17","author":[{"given":"Xiaoshi","family":"Liu","sequence":"first","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]},{"name":"Department of Oncology, The Affiliated Hospital, Southwest Medical University","place":["Luzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Can","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xunwei","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liping","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dengfeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guonan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Gynecologic Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China","place":["Chengdu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,18]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660","article-title":"Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"71","author":"Sung","year":"2021","journal-title":"CA Cancer J Clin"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(21)00046-3","article-title":"Global estimates of expected and preventable cervical cancers among girls born between 2005 and 2014: a birth cohort analysis","volume":"6","author":"Bonjour","year":"2021","journal-title":"Lancet Public Health"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1200\/GO.24.00066","article-title":"Toward a framework to assess the financial and economic burden of cervical cancer in low- and middle-income countries: a systematic review","volume":"10","author":"Fuady","year":"2024","journal-title":"JCO Glob Oncol"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2022.100579","article-title":"Recurrent or primary metastatic cervical cancer: current and future treatments","volume":"7","author":"Gennigens","year":"2022","journal-title":"ESMO Open"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1038\/s41568-023-00659-2","article-title":"Cancer burden in low-income and middle-income countries","volume":"24","author":"Anandasabapathy","year":"2024","journal-title":"Nat Rev Cancer"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2112435","article-title":"Pembrolizumab for persistent, recurrent, or metastatic cervical cancer","volume":"385","author":"Colombo","year":"2021","journal-title":"N Engl J Med"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(22)00554-X","article-title":"Alternative dosing strategies for immune checkpoint inhibitors to improve cost-effectiveness: a special focus on nivolumab and pembrolizumab","volume":"23","author":"Malmberg","year":"2022","journal-title":"Lancet Oncol"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-022-01761-9","article-title":"Cadonilimab: first approval","volume":"82","author":"Keam","year":"2022","journal-title":"Drugs"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)02135-4","article-title":"Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China","volume":"404","author":"Wu","year":"2024","journal-title":"Lancet"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.10.026","article-title":"New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)","volume":"45","author":"Eisenhauer","year":"2009","journal-title":"Eur J Cancer"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2016.03.081","article-title":"RECIST 1.1-update and clarification: from the RECIST committee","volume":"62","author":"Schwartz","year":"2016","journal-title":"Eur J Cancer"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2015.2639","article-title":"Validity and reliability of the US national cancer institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)","volume":"1","author":"Dueck","year":"2015","journal-title":"JAMA Oncol"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32470-X","article-title":"Cervical cancer","volume":"393","author":"Cohen","year":"2019","journal-title":"Lancet"},{"key":"B14","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1016\/S0140-6736(23)02405-4","article-title":"Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial","volume":"403","author":"Oaknin","year":"2023","journal-title":"Lancet"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1200\/jco.1985.3.8.1079","article-title":"Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix: a Gynecologic Oncology Group study","volume":"3","author":"Bonomi","year":"1985","journal-title":"J Clin Oncol"},{"key":"B16","doi-asserted-by":"publisher","first-page":"899","DOI":"10.1002\/1097-0142(19810815)48:4<899::aid-cncr2820480406>3.0.co;2-6","article-title":"Cis-platinum in treatment of advanced or recurrent squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group","volume":"48","author":"Thigpen","year":"1981","journal-title":"Cancer"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2004.04.170","article-title":"Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study","volume":"22","author":"Moore","year":"2004","journal-title":"J Clin Oncol"},{"key":"B18","doi-asserted-by":"publisher","first-page":"702","DOI":"10.1056\/NEJMx170002","article-title":"Improved Survival with Bevacizumab in Advanced Cervical Cancer","volume":"377","author":"Tewari","year":"2017","journal-title":"N Engl J Med"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx235","article-title":"Assessment of nivolumab benefit-risk profile of a 240-mg flat dose relative to a 3-mg\/kg dosing regimen in patients with advanced tumors","volume":"28","author":"Zhao","year":"2017","journal-title":"Ann Oncol"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14051157","article-title":"Comparative effectiveness and safety of standard-dose and low-dose pembrolizumab in patients with non-small-cell lung cancer: a multi-institutional cohort study in Taiwan","volume":"14","author":"Chang","year":"2022","journal-title":"Cancers (Basel)"},{"key":"B21","doi-asserted-by":"publisher","first-page":"192","DOI":"10.1159\/000512000","article-title":"Low-dose nivolumab in renal cell carcinoma: a real-world experience","volume":"99","author":"Zhao","year":"2021","journal-title":"Oncology"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2025.12.015","article-title":"A phase II, randomized, open-label study to evaluate low-dose pembrolizumab plus chemotherapy versus chemotherapy as neoadjuvant therapy for localized triple-negative breast cancer (TNBC) (PLANeT trial-Pembrolizumab Low dose in Addition to NACT in TNBC)","volume":"37","author":"Arora","year":"2025","journal-title":"Ann Oncol"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.1016\/j.xcrm.2023.101242","article-title":"A phase 1a\/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors","volume":"4","author":"Frentzas","year":"2023","journal-title":"Cell Rep Med"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-23-3162","article-title":"Cadonilimab combined with chemotherapy with or without bevacizumab as first-line treatment in recurrent or metastatic cervical cancer (COMPASSION-13): a phase 2 study","volume":"30","author":"Lou","year":"2024","journal-title":"Clin Cancer Res"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1016\/j.iotech.2025.101289","article-title":"206P Pragmatic strategies for managing immune-related adverse events in low- and middle-income countries","volume":"28","author":"Cherradi","year":"2025","journal-title":"Immuno Oncol Technol"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.1136\/jitc-2024-011258","article-title":"Cancer immunotherapy clinical trials to support urgently needed access in low- and middle-income countries: a report from the SITC global access and impact committee","volume":"13","author":"Dent","year":"2025","journal-title":"J Immunother Cancer"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaf315","article-title":"Immune checkpoint inhibitor-associated myocarditis: a novel risk score","volume":"47","author":"Power","year":"2026","journal-title":"Eur Heart J"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaccao.2025.06.009","article-title":"Cardiac troponin screening and clinical outcomes in patients receiving immunotherapy","volume":"7","author":"Cheng","year":"2025","journal-title":"JACC Cardio Oncol"}],"container-title":["Frontiers in Immunology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2026.1871890\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:38:14Z","timestamp":1787031494000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2026.1871890\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,18]]},"references-count":28,"alternative-id":["10.3389\/fimmu.2026.1871890"],"URL":"https:\/\/doi.org\/10.3389\/fimmu.2026.1871890","relation":{},"ISSN":["1664-3224"],"issn-type":[{"value":"1664-3224","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,18]]},"article-number":"1871890"}}