{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T04:28:19Z","timestamp":1777955299597,"version":"3.51.4"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,12,15]],"date-time":"2022-12-15T00:00:00Z","timestamp":1671062400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hematological Oncology"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The primary analysis of the phase 1\/2 ISLANDs study in Japanese individuals with relapsed\/refractory multiple myeloma (RRMM) showed that isatuximab monotherapy was well tolerated and effective, even in participants with high\u2010risk cytogenetic abnormalities. Here, we report a prespecified second analysis conducted 20\u00a0months after the first dosing of the last participant (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    identifier: NCT02812706). The primary objectives were to evaluate the safety and tolerability of isatuximab in phase 1 and to evaluate the efficacy of isatuximab, including assessment of overall response rate (ORR) at the recommended dose (RD), in phase 2. In phase 1, three participants received isatuximab 10\u00a0mg\/kg every week (QW) for 4\u00a0weeks\/cycle followed by every 2\u00a0weeks (Q2W) and five participants received 20\u00a0mg\/kg QW\/Q2W. Since no dose\u2010limiting toxicities occurred in phase 1, 20\u00a0mg\/kg QW\/Q2W was identified as the RD for the phase 2 study (\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u00a028). At the time of data cut\u2010off, three participants (one in phase 1 and two in phase 2) continued to receive isatuximab; disease progression and treatment\u2010related adverse events were the most common reasons for treatment discontinuation. The overall safety profile was consistent with the primary analysis. One death, not related to isatuximab treatment, was reported since the first analysis. The ORR and clinical benefit rate remained unchanged from the primary analysis at 36.4% (95% confidence interval [CI]: 20.4%\u201354.9%) and 54.5% (95% CI: 36.4%\u201371.9%), respectively. The median progression\u2010free survival (PFS) was 5.6\u00a0months, longer than the median PFS reported in the primary analysis (4.7\u00a0months), whereas median overall survival was not reached. Overall, isatuximab 20\u00a0mg\/kg QW\/Q2W had an acceptable safety and tolerability profile and showed promising antitumor activity in Japanese individuals with RRMM.\n                  <\/jats:p>","DOI":"10.1002\/hon.3105","type":"journal-article","created":{"date-parts":[[2022,11,26]],"date-time":"2022-11-26T09:44:06Z","timestamp":1669455846000},"page":"442-452","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Anti\u2010CD38 antibody isatuximab monotherapy for Japanese individuals with relapsed\/refractory multiple myeloma: An update of the phase 1\/2 ISLANDs study"],"prefix":"10.1002","volume":"41","author":[{"given":"Kazutaka","family":"Sunami","sequence":"first","affiliation":[{"name":"Department of Hematology National Hospital Organization, Okayama Medical Center  Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shin\u2010ichi","family":"Fuchida","sequence":"additional","affiliation":[{"name":"Department of Hematology Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Myeloma\/Amyloidosis Center Japanese Red Cross Medical Center  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9617-486X","authenticated-orcid":false,"given":"Masaki","family":"Ri","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Nagoya City University Institute of Medical and Pharmaceutical Sciences  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morio","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Shibukawa Medical Center  Shibukawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chihiro","family":"Shimazaki","sequence":"additional","affiliation":[{"name":"Department of Hematology Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideki","family":"Asaoku","sequence":"additional","affiliation":[{"name":"Hiroshima Red Cross Blood Center  Hiroshima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirohiko","family":"Shibayama","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Osaka National Hospital  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenichi","family":"Ishizawa","sequence":"additional","affiliation":[{"name":"Department of Third Internal Medicine Division of Hematology and Cell Therapy Yamagata University Faculty of Medicine  Yamagata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Takamatsu","sequence":"additional","affiliation":[{"name":"Department of Hematology Faculty of Medicine Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University  Kanazawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3976-5230","authenticated-orcid":false,"given":"Takashi","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Division of Hematology and Stem Cell Transplantation Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0654-6920","authenticated-orcid":false,"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazunori","family":"Imada","sequence":"additional","affiliation":[{"name":"Department of Hematology Japanese Red Cross Osaka Hospital  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michihiro","family":"Uchiyama","sequence":"additional","affiliation":[{"name":"Department of Hematology Japanese Red Cross Society Suwa Hospital  Suwa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toru","family":"Kiguchi","sequence":"additional","affiliation":[{"name":"Department of Hematology Chugoku Central Hospital  Fukuyama Japan"},{"name":"Division of Diabetes, Endocrinology and Hematology Dokkyo Medical University Saitama Medical Center  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Iyama","sequence":"additional","affiliation":[{"name":"Department of Hematology Sapporo Medical University School of Medicine  Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Murakami","sequence":"additional","affiliation":[{"name":"Department of Laboratory Sciences Gunma University Graduate School of Health Sciences  Maebashi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reiko","family":"Onishi","sequence":"additional","affiliation":[{"name":"Sanofi, Research and Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keisuke","family":"Tada","sequence":"additional","affiliation":[{"name":"Sanofi, Research and Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4951-960X","authenticated-orcid":false,"given":"Shinsuke","family":"Iida","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Nagoya City University Institute of Medical and Pharmaceutical Sciences  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,12,15]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.33762"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2019.1686870"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.13707"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyab178"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1309\/74r4tb90buwh27jx"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/imr.12389"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078\u20100432.ccr\u201014\u20100695"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2015.240"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41408\u2010019\u20100198\u20104"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.14657"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375\u2010020\u20100857\u20102"},{"key":"e_1_2_11_13_1","unstructured":"European Medicines Agency.SARCLISA (Isatuximab): EU Summary of Product Characteristics;2021. Accessed 16 February 2022.https:\/\/www.ema.europa.eu\/en"},{"key":"e_1_2_11_14_1","unstructured":"US Food and Drug Administration.SARCLISA\u00ae(Isatuximab\u2010irfc) Injection for Intravenous Use: Highlights of Prescribing Information;2021. Accessed 16 February 2022.https:\/\/products.sanofi.us\/sarclisa\/sarclisa.pdf"},{"key":"e_1_2_11_15_1","unstructured":"SanofiKK.Sarclisa Intravenous Infusion 100mg\/Sarclisa Intravenous Infusion 500mg: Japanese Prescribing Information;2020. Accessed 16 February 2022.https:\/\/www.pmda.go.jp\/"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2013.48.7934"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.hs9.0000560864.06450.a4"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020008209"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102011\u201006\u2010360552"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185\u2010017\u20102281\u20106"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2352\u20103026(20)30081\u20108"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(15)01120\u20104"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010020\u201001311\u20101"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010015\u20100536\u20101"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019000667"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.2217\/fon\u20102019\u20100431"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)32556-5"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1470\u20102045(22)00019\u20105"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00592-4"},{"key":"e_1_2_11_30_1","unstructured":"Pharmaceuticals and Medical Devices Agency.SARCLISA\u00aeI.V. 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Accessed 11 February 2022.https:\/\/pins.japic.or.jp\/pdf\/newPINS\/00068881.pdf"}],"container-title":["Hematological Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hon.3105","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/hon.3105","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hon.3105","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,9]],"date-time":"2023-08-09T15:31:50Z","timestamp":1691595110000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hon.3105"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,15]]},"references-count":29,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,8]]}},"alternative-id":["10.1002\/hon.3105"],"URL":"https:\/\/doi.org\/10.1002\/hon.3105","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1002\/HON.3105\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1002\/HON.3105\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1002\/HON.3105\/v2\/decision1","asserted-by":"object"}]},"ISSN":["0278-0232","1099-1069"],"issn-type":[{"value":"0278-0232","type":"print"},{"value":"1099-1069","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,15]]},"assertion":[{"value":"2022-08-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-12-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}