{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:07:10Z","timestamp":1792793230272,"version":"4.5.0"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2024,11,28]],"date-time":"2024-11-28T00:00:00Z","timestamp":1732752000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,11,28]],"date-time":"2024-11-28T00:00:00Z","timestamp":1732752000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100020707","name":"Janssen Japan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020707","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:p>We characterized the safety and efficacy of the bispecific antibody teclistamab in Japanese patients with relapsed\/refractory multiple myeloma (RRMM). Patients were pretreated with a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and anti-CD38 monoclonal antibody (mAb). The primary endpoint was frequency and type of treatment-emergent adverse events (TEAEs) in phase 1, and overall response rate (ORR;\u2009\u2265\u2009partial response [PR]) in phase 2. In phase 1, 14 patients received once-weekly (QW) subcutaneous teclistamab (0.72\u00a0mg\/kg [n\u2009=\u20095]; 1.5\u00a0mg\/kg [n\u2009=\u20095]; 3\u00a0mg\/kg [n\u2009=\u20094]). No dose-limiting toxicities were observed. As of April 2024, 26 phase-2 patients received the recommended phase-2 dose (QW) (RP2D: 1.5\u00a0mg\/kg) of teclistamab. Biweekly (Q2W) dosing was allowed after maintaining response for\u2009\u2265\u20096\u00a0months. At a median follow-up of 14.32\u00a0months, ORR was 76.9% (\u2265\u2009very good PR: 76.9%;\u2009\u2265\u2009complete response: 65.4%). Median duration of response, progression-free survival, and overall survival were not reached. Common TEAEs included CRS (grade\u2009\u2264\u20092), neutropenia, and infections. No patient had immune effector cell-associated neurotoxicity syndrome (ICANS) and dose reductions. Teclistamab demonstrated deep and durable responses in Japanese patients with RRMM, consistent with the global pivotal MajesTEC-1 study, supporting the potential for a new standard of care for Japanese RRMM patients.<\/jats:p>","DOI":"10.1007\/s12185-024-03884-z","type":"journal-article","created":{"date-parts":[[2024,11,28]],"date-time":"2024-11-28T11:17:09Z","timestamp":1732792629000},"page":"222-231","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["A Phase 1\/2 study of teclistamab, a humanized BCMA\u2009\u00d7\u2009CD3 bispecific Ab in Japanese patients with relapsed\/refractory MM"],"prefix":"10.1007","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3219-3292","authenticated-orcid":false,"given":"Tadao","family":"Ishida","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0226-7626","authenticated-orcid":false,"given":"Yoshiaki","family":"Kuroda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kosei","family":"Matsue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuya","family":"Komeno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuro","family":"Ishiguro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Ishikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiro","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3230-4837","authenticated-orcid":false,"given":"Hiroshi","family":"Kosugi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8229-7439","authenticated-orcid":false,"given":"Kazutaka","family":"Sunami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3971-7790","authenticated-orcid":false,"given":"Kazuko","family":"Nishikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Shibayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensuke","family":"Aida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Yamazaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuo","family":"Inagaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6394-1989","authenticated-orcid":false,"given":"Hisanori","family":"Kobayashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4951-960X","authenticated-orcid":false,"given":"Shinsuke","family":"Iida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,11,28]]},"reference":[{"issue":"1","key":"3884_CR1","doi-asserted-by":"publisher","first-page":"565","DOI":"10.1080\/13696998.2023.2197811","volume":"26","author":"T Ishida","year":"2023","unstructured":"Ishida T, Nakakoji M, Murata T, Matsuyama F, Iida S. Evaluating process utilities for the treatment burden of chemotherapy in multiple myeloma in Japan: a time trade-off valuation study. J Med Econ. 2023;26(1):565\u201373. https:\/\/doi.org\/10.1080\/13696998.2023.2197811.","journal-title":"J Med Econ"},{"issue":"9","key":"3884_CR2","doi-asserted-by":"publisher","first-page":"e670","DOI":"10.1016\/s2352-3026(22)00165-x","volume":"9","author":"J Huang","year":"2022","unstructured":"Huang J, Chan SC, Lok V, Zhang L, Lucero-Prisno DE 3rd, Xu W, et al. The epidemiological landscape of multiple myeloma: a global cancer registry estimate of disease burden, risk factors, and temporal trends. Lancet Haematol. 2022;9(9):e670\u20137. https:\/\/doi.org\/10.1016\/s2352-3026(22)00165-x.","journal-title":"Lancet Haematol"},{"key":"3884_CR3","doi-asserted-by":"publisher","first-page":"341430","DOI":"10.1155\/2015\/341430","volume":"2015","author":"WC Yang","year":"2015","unstructured":"Yang WC, Lin SF. 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Honoraria received from BMS, CSL Behring, Janssen, Ono, Pfizer, Sanofi, and Takeda. Yoshiaki Kuroda: Payment or honoraria received from Amgen, Asahi Kasei Pharma, Astrazeneca, BMS, Janssen, Ono, Sanofi, SymBio Pharmaceuticals, and Takeda Pharmaceuticals. Kosei Matsue: Grants or contract received from Astrazeneca. Takuya Komeno: Grants or contracts received from Abbvie, BMS, Janssen Pharmaceutical K.K., and Sanofi. Takuro Ishiguro: Payment or honoraria received from Janssen Pharmaceutical K.K., Sanofi, BMS, Ono Pharmaceutical, Takeda Pharmaceutical Company Limited, and Novartis. Jun Ishikawa: None. Toshiro Ito: None. Hiroshi Kosugi: Payment or honoraria received from Abbvie G.K., Asahi Kasei Pharma, Astrazeneca K.K., Beckton Dickinson K.K., BMS K.K., Chugai, GSK K.K., Janssen Pharmaceutical K.K., Japan Blood Products Organization, Kyowa Kirin, Kissei Pharmaceutical, Nippon Shinyaku, Novartis Pharma K.K., Novo Nordisk Pharma Japan, Ono, Sanofi K.K., and Takeda. Kazutaka Sunami: Research funding received from: Abbvie, Beigene, BMS, Chugai, GSK, Incyte, Janssen, Kyowa Kirin, Mitsubishi Tanabe, Novartis, Ono, Otsuka, Pfizer, and Sanofi. Honoraria received from BMS, Janssen, and Sanofi. Kazuko Nishikawa: Employee of Janssen Pharmaceutical K.K. Kazuhiro Shibayama: Employee of Janssen Pharmaceutical K.K., and own stock or stock options in Johnson & Johnson. Kensuke Aida: Employee of Janssen Pharmaceutical K.K. Hiroshi Yamazaki: Employee of Janssen Pharmaceutical K.K., own stocks or stock options in Kameya Shoji Co., Ltd. Mitsuo Inagaki: Employee of Janssen Pharmaceutical K.K., and own stocks or stock options in Johnson & Johnson. Hisanori Kobayashi: Employee of Janssen Pharmaceutical K.K., and own stocks or stock options in Johnson and Johnson. Shinsuke Iida: All support for the present manuscript received from Janssen. Grants received from Abbvie, Amgen, BMS, Daiichi Sankyo, GSK, Janssen, Novartis, Ono, Otsuka, Pfizer Sanofi, Shionogi, and Takeda. Consulting fees received from Abbvie, Astrazeneca, BMS, GSK, Janssen, Novartis, Otsuka, Pfizer, and Sanofi. Payment or honoraria received from Astrazeneca, BMS, Janssen, Ono, Pfizer, Sanofi, and Takeda. Other financial or non-financial interests received from Chugai.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study protocol and associated study documents were approved by the Institutional Review Board. Good Clinical Practice (GCP) guidelines, established by the International Council for Harmonization (ICH), and all relevant regulatory requirements were followed during the conduct of this study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}