{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T09:15:32Z","timestamp":1788513332362,"version":"build-2803163510"},"reference-count":18,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Considering the inconvenience brought by long\u2010term administration of intravenous (IV) immune checkpoint inhibitors for cancer treatment, subcutaneous (SC) formulation needs to be explored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This dose\u2010finding Phase 1 study (NCT05751486) investigated SC toripalimab in patients with recurrent or metastatic nasopharyngeal carcinoma (RM\u2010NPC). In the initial dose\u2010exploration cohorts, patients received SC toripalimab 240\u2009mg Q3W or 480\u2009mg Q6W, followed by a subsequent exploratory cohort receiving 360\u2009mg Q3W, in combination with gemcitabine and cisplatin. The primary endpoint was pharmacokinetic profile of SC toripalimab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 24 November 2022 and 31 July 2023, 38 patients were enrolled (12, 13 and 13 patients received 240\u2009mg Q3W, 360\u2009mg Q3W and 480\u2009mg Q6W SC toripalimab, respectively). As of the data cut\u2010off date, the median follow\u2010up was 17.2\u2009months. SC toripalimab 360\u2009mg Q3W provided similar serum trough concentration (C\n                      <jats:sub>trough<\/jats:sub>\n                      ) and area under the curve (AUC) in Cycle 1 to the corresponding IV toripalimab 240\u2009mg Q3W. SC toripalimab was well tolerated and exhibited a safety profile consistent with the established IV formulation. The objective response rates were 100% (95% CI 73.5, 100), 92.3% (95% CI 64.0, 99.8) and 92.3% (95% CI 64.0, 99.8) in the 240\u2009mg Q3W, 360\u2009mg Q3W and 480\u2009mg Q6W cohorts, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      SC toripalimab showed consistent safety and antitumour activity with IV toripalimab for the first\u2010line treatment of RM\u2010NPC. Similar C\n                      <jats:sub>trough<\/jats:sub>\n                      and AUC values in cycle 1 of SC toripalimab 360\u2009mg Q3W with IV toripalimab reference support further study.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70796","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T08:39:57Z","timestamp":1788511197000},"source":"Crossref","is-referenced-by-count":0,"title":["A Phase 1 study of subcutaneous toripalimab in recurrent or metastatic nasopharyngeal carcinoma"],"prefix":"10.1002","author":[{"given":"Hai\u2010Qiang","family":"Mai","sequence":"first","affiliation":[{"name":"Sun Yat\u2010sen University Cancer Center State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya\u2010Qian","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Radiotherapy Hunan Cancer Hospital  Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kun\u2010Yu","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Union Hospital, Cancer Center, Tongji Medical College Huazhong University of Science and Technology  Wuhan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guo\u2010Wu","family":"Wu","sequence":"additional","affiliation":[{"name":"Medical Oncology Meizhou People's Hospital  Meizhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuan\u2010Ben","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Radiotherapy Fujian Cancer Hospital  Fuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mo","family":"Wang","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xian\u2010Ming","family":"Luo","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuang\u2010Hui","family":"Wei","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xi","family":"Tan","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui\u2010Mei","family":"Xie","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian\u2010Jun","family":"Zou","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui\u2010Hua","family":"Xu","sequence":"additional","affiliation":[{"name":"Sun Yat\u2010sen University Cancer Center State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,4]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12964\u2010022\u201000854\u2010y"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.59.4358"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1158\/2159\u20108290.CD\u201018\u20100367"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trecan.2024.03.006"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.21037\/tlcr\u201024\u201063"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13045\u2010021\u201001095\u20101"},{"issue":"8","key":"e_1_2_11_8_1","doi-asserted-by":"crossref","first-page":"693","DOI":"10.1016\/j.annonc.2023.05.009","article-title":"IMscin001 part 2: a randomised phase III, open\u2010label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non\u2010small\u2010cell lung cancer and pharmacokinetics comparison with other approved indications","volume":"34","author":"Burotto M","year":"2023","journal-title":"Ann Oncol"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.12.005"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2024.05.005"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078\u20100432.CCR\u201021\u20102210"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2022.02.007"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.24735"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.00727"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.20181"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.02712"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.16176"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3150"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/10781552221137702"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70796","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bcp.70796","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70796","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T08:39:59Z","timestamp":1788511199000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70796"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,4]]},"references-count":18,"alternative-id":["10.1002\/bcp.70796"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70796","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,4]]},"article-number":"bcp.70796"}}