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We report the first efficacy and safety results of talquetamab in Japanese patients enrolled as a separate cohort in the global MonumenTAL-1 study. Between July 2022 and December 2023, 36 patients were enrolled and received 0.4\u00a0mg\/kg talquetamab weekly. Median follow-up was 13.4 months. The overall response rate was 77.8% (55.6% achieved complete response or better). Median time to first response was 1.2 months. Twelve-month duration of response, progression-free survival, and overall survival rates were 66.4%, 56.3%, and 74.1%, respectively. On-target, off-tumor adverse events (AEs), including taste-, skin- (non-rash), nail-, and rash-related AEs, were common (80.6%, 66.7%, 55.6%, and 36.1%, respectively) and mostly grade 1\/2. Cytokine release syndrome occurred in 75.0% of patients; all events were grade 1\/2. The rate of infection was 52.8%; the rate of grade 3\/4 infection was 16.7% (one led to death [pneumonia]). One patient discontinued talquetamab and three patients died due to AEs. Results were generally consistent with the global MonumenTAL-1 population, demonstrating talquetamab as an important novel treatment for Japanese patients with RRMM. Clinical trial registration number: NCT03399799\/NCT04634552.<\/jats:p>","DOI":"10.1007\/s12185-025-04134-6","type":"journal-article","created":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T05:51:03Z","timestamp":1765950663000},"page":"580-592","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Talquetamab in Japanese patients with relapsed\/refractory multiple myeloma in the MonumenTAL-1 study"],"prefix":"10.1007","volume":"123","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3899-6603","authenticated-orcid":false,"given":"Shigeki","family":"Ito","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiaki","family":"Kuroda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazutaka","family":"Sunami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kosei","family":"Matsue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazunori","family":"Imada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideto","family":"Tamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ei","family":"Fujikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Yamazaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikihiro","family":"Takamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lixia","family":"Pei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Qin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tara J.","family":"Masterson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michela","family":"Campagna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronique","family":"Vreys","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie W.","family":"Lau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Takamatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,12,17]]},"reference":[{"issue":"10272","key":"4134_CR1","doi-asserted-by":"publisher","first-page":"410","DOI":"10.1016\/s0140-6736(21)00135-5","volume":"397","author":"N van de Donk","year":"2021","unstructured":"van de Donk N, Pawlyn C, Yong KL. 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Yoshiaki Kuroda has received research funding and participates in a speakers bureau for Johnson & Johnson, Takeda Pharmaceuticals, Bristol Myers Squibb, Sano, SymBio Pharmaceuticals, ONO PHARMACEUTICAL, AstraZeneca, ASAHI KASEI PHARMA, and Amgen. Kazutaka Sunami has received research funding from Sano, Pzer, Ono Pharmaceutical, Novartis, Mitsubishi Tanabe, Kyowa-Kirin, Incyte, GSK, Chugai, BMS, BeiGene, and AbbVie; and has received honoraria and research funding from Johnson & Johnson. Kosei Matsue has received trust research\/joint research funds from AstraZeneca; and has received honoraria from Johnson & Johnson, BMS, and Takeda. Kazunori Imada has received honoraria from Johnson & Johnson K.K., Towa Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Alexion Pharmaceuticals, Inc., AbbVie GK., Astellas Pharma Inc., Amgen K.K., AstraZeneca K.K., and DAIICHI SANKYO Co., Ltd.; has received other honoraria from Genmab K.K., Chugai Pharmaceutical Co., Ltd., Bristol-Myers Squibb K.K., Ono Pharmaceutical Co. Ltd., Otuka Pharmaceutical Co. Ltd. and Pzer Japan Inc.; and has received patents & royalties honoraria from Gilead Sciences K.K., PharmaEssentia Japan KK, Kyowa Kirin Co., Ltd., Novartis Pharma K.K., Sano K.K., Asahi Kasei Pharma, Nippon Kayaku Co., Ltd., Nippon Shinyaku Co., Ltd., and Eisai Co., Ltd. Hideto Tamura has participated in a speakers bureau for Bristol Meyers Squib; has received honoraria from Ono Pharmaceutical and Sano; has received consultation fees for Sanofi, AbbVie, and Johnson & Johnson; has received remuneration for lectures for Johnson & Johnson, BMS, Sanofi, Ono Pharmaceutical Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co., Ltd.; and has received a scholarship fund from Fujipharm Co., Ltd. Ei Fujikawa, Hiroshi Yamazaki, Mikihiro Takamoto, Lixia Pei, Xiang Qin, Tara J. Masterson, Michela Campagna, Veronique Vreys, and Bonnie W Lau are current employees of Johnson & Johnson and hold equity in a publicly-traded company. Yasushi Takamatsu has received speaking fees from AstraZeneca and Sanofi; and has received scholarship or grant donations from Chugai Pharmaceutical, Takeda Pharmaceuticals, and Astellas Pharma.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Registry and the registration number of the study:\n                      \n                      ; NCT03732820. The study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Guidelines of the International Council for Harmonisation. The protocol and amendments were approved by the institutional review board at each study site.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent. Written consent for the publication of the medical photographs was obtained from the patient(s).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}