{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T10:49:07Z","timestamp":1768819747189,"version":"3.49.0"},"reference-count":30,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T00:00:00Z","timestamp":1705017600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017723","name":"Innovent Biologics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017723","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The development of immune checkpoint inhibitors has made a significant breakthrough in the treatment of non\u2010small\u2010cell lung cancer (NSCLC). However, there remains a huge unmet clinical need for patients with acquired resistance after initial treatment response.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study evaluated the combination of IBI310 (an anti\u2010cytotoxic T lymphocyte\u2010associated antigen\u20104 [CTLA\u20104] antibody) and sintilimab (an anti\u2010programmed death 1 [PD\u20101]) antibody) in NSCLC patients who have previously been treated with anti\u2010PD\u20101\/ligand (L)1 and acquired resistance. The patients were randomly assigned to receive either a lower dose of IBI310 (1\u2009mg\/kg Q3W, cohort A) or a higher dose of IBI310 (3\u2009mg\/kg Q3W, cohort B) in combination with sintilimab (200\u2009mg Q3W). The primary endpoints of the study were objective response rate (ORR) assessed by RECISTv1.1 and safety, while secondary endpoints included disease control rate (DCR), progression\u2010free survival (PFS), and overall survival (OS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>As of November 2, 2023, the study had enrolled 30 patients, with 15 patients in each cohort. The ORR was 13.3% (2\/15, 95% confidence interval [CI], 1.7\u201340.5) in cohort B. DCR were 46.7% (95% CI, 21.3\u201373.4) and 66.7% (95% CI, 38.4\u201388.2) in cohorts A and B, respectively. In cohorts A and B of this trial, the median follow\u2010up times were 4.2 and 5.6\u2009months, respectively. Median PFS was 1.45 (95% CI, 1.35\u20132.73) versus 2.73 (95% CI, 1.41\u20134.90) months for cohort A versus B; the median OS was 7.03 (95% CI, 3.09\u2013not calculable [NC]) months in cohort A and 8.90 (95% CI, 5.13\u2013NC) months in cohort B. Of the 30 patients, 86.7% in both cohorts experienced treatment\u2010related adverse events (TRAEs) with Grade\u2009\u22653 TRAEs occurring in 40% and 53.3% of patients in cohorts A and B, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>IBI310 3\u2009mg\/kg Q3W plus sintilimab was effective in a small number of previously treated anti\u2010PD\u20101\/L1\u2010resistant NSCLC patients.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.6855","type":"journal-article","created":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T09:07:14Z","timestamp":1705050434000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A phase Ib study evaluating the safety and efficacy of <scp>IBI310<\/scp> plus sintilimab in patients with advanced non\u2010small\u2010cell lung cancer who have progressed after <scp>anti\u2010PD<\/scp>\u20101\/<scp>L1<\/scp> therapy"],"prefix":"10.1002","volume":"13","author":[{"given":"Yuguang","family":"Zhao","sequence":"first","affiliation":[{"name":"The First Hospital of Jilin University  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao","family":"Chen","sequence":"additional","affiliation":[{"name":"The First Hospital of Jilin University  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Yao","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Henan University of Science and Technology  Luoyang China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianlin","family":"Long","sequence":"additional","affiliation":[{"name":"Chongqing University Affiliated Cancer Hospital  Chongqing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yong","family":"Mao","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Jiangnan University  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Di","family":"Wu","sequence":"additional","affiliation":[{"name":"The First Hospital of Jilin University  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aimin","family":"Zang","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Hebei University  Baoding China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1464-7158","authenticated-orcid":false,"given":"Jun","family":"Zhao","sequence":"additional","affiliation":[{"name":"Beijing Cancer Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ziling","family":"Liu","sequence":"additional","affiliation":[{"name":"The First Hospital of Jilin University  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rui","family":"Meng","sequence":"additional","affiliation":[{"name":"Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ye","family":"Chen","sequence":"additional","affiliation":[{"name":"Innovent Biologics, Inc.  Suzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Luo","sequence":"additional","affiliation":[{"name":"Innovent Biologics, Inc.  Suzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qun","family":"Guo","sequence":"additional","affiliation":[{"name":"Innovent Biologics, Inc.  Suzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Li","sequence":"additional","affiliation":[{"name":"Innovent Biologics, Inc.  Suzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6496-7550","authenticated-orcid":false,"given":"Jiuwei","family":"Cui","sequence":"additional","affiliation":[{"name":"The First Hospital of Jilin University  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,1,12]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1801005"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910231"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1917346"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(20)30641-0"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1810865"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1606774"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00228-2"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1716948"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2020.07.014"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.823618"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/ncomms10501"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1401686"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/19420862.2019.1654303"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2021.08.2133"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2021.08.1471"},{"issue":"4","key":"e_1_2_11_18_1","first-page":"421","article-title":"A phase Ib, multicenter, open\u2010label study to assess the safety, tolerability, and preliminary efficacy of sintilimab plus IBI310 (anti\u2010CTLA4 mAb) in patients with advanced hepatocellular carcinoma","volume":"40","author":"Zhou J","year":"2022","journal-title":"J Clin Orthod"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc-2019-000398"},{"issue":"15","key":"e_1_2_11_20_1","first-page":"TPS9134","article-title":"CONTACT\u201001: a phase III, randomized study of atezolizumab plus cabozantinib versus docetaxel in patients with metastatic non\u2010small cell lung cancer (mNSCLC) previously treated with PD\u2010L1\/PD\u20101 inhibitors and platinum\u2010containing chemotherapy","volume":"39","author":"Neal JW","year":"2021","journal-title":"J Clin Orthod"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.00912"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-134869"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12943-021-01489-2"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-immunol-070621-030155"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13578-023-01073-9"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2023.03.006"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40164-019-0150-0"},{"issue":"24","key":"e_1_2_11_28_1","first-page":"2647","article-title":"Pembrolizumab plus Ipilimumab following anti\u2010PD\u20101\/L1 failure in melanoma","volume":"39","author":"Olson DJ","year":"2021","journal-title":"J Clin Orthod"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1302369"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2021.100273"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)30624-6"}],"container-title":["Cancer Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cam4.6855","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,9]],"date-time":"2024-04-09T06:07:42Z","timestamp":1712642862000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cam4.6855"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,12]]},"references-count":30,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1002\/cam4.6855"],"URL":"https:\/\/doi.org\/10.1002\/cam4.6855","archive":["Portico"],"relation":{},"ISSN":["2045-7634","2045-7634"],"issn-type":[{"value":"2045-7634","type":"print"},{"value":"2045-7634","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,12]]},"assertion":[{"value":"2023-06-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-11","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e6855"}}