{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:49:47Z","timestamp":1792082987930,"version":"4.4.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T00:00:00Z","timestamp":1768176000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T00:00:00Z","timestamp":1768176000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Chugai Pharmaceutical Co., Ltd"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>JO40295 (jRCT2080223801) evaluated the efficacy and safety of subcutaneous (SC) mosunetuzumab, in combination with lenalidomide and as monotherapy, in Japanese patients with relapsed\/refractory (R\/R) follicular lymphoma (FL). We report outcomes from the interim analysis of the FLMOON-2 (\u2265\u20091 prior therapy; mosunetuzumab plus lenalidomide) and primary analysis of the FLMOON-3 (\u2265\u20092 prior therapies; mosunetuzumab monotherapy) cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Mosunetuzumab SC was administered with Cycle (C)1 step-up dosing in both cohorts: C1 Day (D)1, 5\u00a0mg; C1D8, D15 and C2 onwards, 45\u00a0mg. In FLMOON-2, oral lenalidomide was administered from C2 onwards, on D1\u201321 of each cycle. Treatment was administered up to C12 in FLMOON-2 and C8 or C17 in FLMOON-3. The primary endpoint was independent review facility-assessed complete response (CR) rate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At the clinical cut-off date (FLMOON-2: April 4, 2024; FLMOON-3: March 4, 2024), in the efficacy-evaluable populations, CR rate was 92.3% in FLMOON-2 (n\u2009=\u200913) and 100% in FLMOON-3 (n\u2009=\u20095). In the safety-evaluable populations (FLMOON-2, n\u2009=\u200917; FLMOON-3, n\u2009=\u20095), Grade 3\/4 adverse events (AEs) occurred in 64.7% of patients in FLMOON-2 and 20.0% in FLMOON-3. No Grade 5 AEs or AEs leading to treatment discontinuation occurred in either cohort. Cytokine release syndrome was reported in 47.1% of patients in FLMOON-2 and 20.0% in FLMOON-3. Serum mosunetuzumab concentration peaked with the third dose of mosunetuzumab in C1 and reached a steady state with repeated dosing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Mosunetuzumab SC, in combination with lenalidomide and as monotherapy, demonstrated promising efficacy with a manageable safety profile in Japanese patients with R\/R FL.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-025-02957-1","type":"journal-article","created":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T17:54:40Z","timestamp":1768240480000},"page":"456-466","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of subcutaneous mosunetuzumab in combination with lenalidomide and as a monotherapy in Japanese patients with relapsed\/refractory follicular lymphoma"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6609-8088","authenticated-orcid":false,"given":"Shinichi","family":"Makita","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Mishima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Kumode","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junya","family":"Kuroda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuhiro","family":"Kanemura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Fukuhara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuyuki","family":"Shimada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiemi","family":"Mori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuko","family":"Kawasaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Miyake","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,12]]},"reference":[{"issue":"11","key":"2957_CR1","doi-asserted-by":"publisher","first-page":"5843","DOI":"10.1002\/cam4.1805","volume":"7","author":"R Muto","year":"2018","unstructured":"Muto R, Miyoshi H, Sato K et al (2018) Epidemiology and secular trends of malignant lymphoma in Japan: analysis of 9426 cases according to the World Health Organization classification. Cancer Med 7(11):5843\u20135858. https:\/\/doi.org\/10.1002\/cam4.1805","journal-title":"Cancer Med"},{"issue":"3","key":"2957_CR2","doi-asserted-by":"publisher","first-page":"316","DOI":"10.1002\/ajh.25696","volume":"95","author":"A Freedman","year":"2020","unstructured":"Freedman A, Jacobsen E (2020) Follicular lymphoma: 2020 update on diagnosis and management. Am J Hematol 95(3):316\u2013327. https:\/\/doi.org\/10.1002\/ajh.25696","journal-title":"Am J Hematol"},{"issue":"7","key":"2957_CR3","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1038\/s41408-020-00340-z","volume":"10","author":"CL Batlevi","year":"2020","unstructured":"Batlevi CL, Sha F, Alperovich A et al (2020) Follicular lymphoma in the modern era: survival, treatment outcomes, and identification of high-risk subgroups. Blood Cancer J 10(7):74. https:\/\/doi.org\/10.1038\/s41408-020-00340-z","journal-title":"Blood Cancer J"},{"issue":"5","key":"2957_CR4","doi-asserted-by":"publisher","first-page":"577","DOI":"10.1007\/s12185-025-03922-4","volume":"121","author":"K Izutsu","year":"2025","unstructured":"Izutsu K, Fukuhara N (2025) JSH practical guidelines for hematological malignancies, 2023: II. Lymphoma-1. Follicular lymphoma (FL). Int J Hematol 121(5):577\u2013585. https:\/\/doi.org\/10.1007\/s12185-025-03922-4","journal-title":"Int J Hematol"},{"issue":"1","key":"2957_CR5","doi-asserted-by":"publisher","first-page":"2412869","DOI":"10.1080\/2162402x.2024.2412869","volume":"13","author":"A Rivas-Delgado","year":"2024","unstructured":"Rivas-Delgado A, Landego I, Falchi L (2024) The landscape of T-cell engagers for the treatment of follicular lymphoma. Oncoimmunology 13(1):2412869. https:\/\/doi.org\/10.1080\/2162402x.2024.2412869","journal-title":"Oncoimmunology"},{"key":"2957_CR6","unstructured":"US Food and Drug Adminstration (2022) Lunsumio: FDA prescribing information. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761263s000lbl.pdf. Accessed 13 Oct 2025"},{"key":"2957_CR7","unstructured":"European Medicines Agency (2022) Lunsumio: summary of product characteristics. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/lunsumio-epar-product-information_en.pdf. Accessed 13 Oct 2025"},{"issue":"8","key":"2957_CR8","doi-asserted-by":"publisher","first-page":"1055","DOI":"10.1016\/s1470-2045(22)00335-7","volume":"23","author":"LE Budde","year":"2022","unstructured":"Budde LE, Sehn LH, Matasar M et al (2022) Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol 23(8):1055\u20131065. https:\/\/doi.org\/10.1016\/s1470-2045(22)00335-7","journal-title":"Lancet Oncol"},{"issue":"7","key":"2957_CR9","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1182\/blood.2024025454","volume":"145","author":"LH Sehn","year":"2025","unstructured":"Sehn LH, Bartlett NL, Matasar MJ et al (2025) Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after \u22652 prior therapies. Blood 145(7):708\u2013719. https:\/\/doi.org\/10.1182\/blood.2024025454","journal-title":"Blood"},{"issue":"2","key":"2957_CR10","doi-asserted-by":"publisher","first-page":"389","DOI":"10.1007\/s10147-024-02662-5","volume":"30","author":"H Goto","year":"2025","unstructured":"Goto H, Kumode T, Mishima Y et al (2025) Efficacy and safety of mosunetuzumab monotherapy for Japanese patients with relapsed\/refractory follicular lymphoma: FLMOON-1. Int J Clin Oncol 30(2):389\u2013396. https:\/\/doi.org\/10.1007\/s10147-024-02662-5","journal-title":"Int J Clin Oncol"},{"key":"2957_CR11","unstructured":"Pharmaceuticals and Medical Devices Agency (2025) List of approved drugs. https:\/\/www.pmda.go.jp\/files\/000274881.pdf. Accessed 27 Oct 2025"},{"issue":"Supplement 1","key":"2957_CR12","doi-asserted-by":"publisher","first-page":"129","DOI":"10.1182\/blood-2021-145694","volume":"138","author":"F Morschhauser","year":"2021","unstructured":"Morschhauser F, Bishton M, Eyre TA et al (2021) Mosunetuzumab in combination with lenalidomide has a manageable safety profile and encouraging activity in patients with relapsed\/refractory follicular lymphoma: initial results from a Phase Ib study. Blood 138(Supplement 1):129. https:\/\/doi.org\/10.1182\/blood-2021-145694","journal-title":"Blood"},{"issue":"Suppl","key":"2957_CR13","doi-asserted-by":"publisher","first-page":"1015","DOI":"10.1097\/01.HS9.0000847368.92731.fb","volume":"6","author":"L Nastoupil","year":"2022","unstructured":"Nastoupil L, Morschhauser F, Scholz CW et al (2022) P1125: CELESTIMO: a phase III trial evaluating the efficacy and safety of mosunetuzumab plus lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma. Hemasphere 6(Suppl):1015\u20131016. https:\/\/doi.org\/10.1097\/01.HS9.0000847368.92731.fb","journal-title":"Hemasphere"},{"key":"2957_CR14","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2024-194612","volume":"144","author":"NL Bartlett","year":"2024","unstructured":"Bartlett NL, Sehn LH, Assouline SE et al (2024) Subcutaneous mosunetuzumab leads to high rates of durable responses, low rates of cytokine release syndrome, and non-inferior exposure compared with intravenous administration in patients with relapsed\/refractory follicular lymphoma: primary analysis of a pivotal phase II. Blood 144:1645. https:\/\/doi.org\/10.1182\/blood-2024-194612","journal-title":"Blood"},{"key":"2957_CR15","unstructured":"F. Hoffmann-La Roche Ltd (2025) European Commission approves Roche\u2019s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma. https:\/\/www.roche.com\/media\/releases\/med-cor-2025-11-19. Accessed 04 Dec 2025"},{"issue":"5","key":"2957_CR16","doi-asserted-by":"publisher","first-page":"481","DOI":"10.1200\/jco.21.00931","volume":"40","author":"LE Budde","year":"2022","unstructured":"Budde LE, Assouline S, Sehn LH et al (2022) Single-agent mosunetuzumab shows durable complete responses in patients with relapsed or refractory B-cell lymphomas: Phase I dose-escalation study. J Clin Oncol 40(5):481\u2013491. https:\/\/doi.org\/10.1200\/jco.21.00931","journal-title":"J Clin Oncol"},{"issue":"27","key":"2957_CR17","doi-asserted-by":"publisher","first-page":"3059","DOI":"10.1200\/jco.2013.54.8800","volume":"32","author":"BD Cheson","year":"2014","unstructured":"Cheson BD, Fisher RI, Barrington SF et al (2014) Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol 32(27):3059\u20133068. https:\/\/doi.org\/10.1200\/jco.2013.54.8800","journal-title":"J Clin Oncol"},{"key":"2957_CR18","unstructured":"Department of Health and Human Services (2010) Common terminology for adverse events (CTCAE) v4.03. https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03\/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed 13 Oct 2025"},{"issue":"2","key":"2957_CR19","doi-asserted-by":"publisher","first-page":"188","DOI":"10.1182\/blood-2014-05-552729","volume":"124","author":"DW Lee","year":"2014","unstructured":"Lee DW, Gardner R, Porter DL et al (2014) Current concepts in the diagnosis and management of cytokine release syndrome. Blood 124(2):188\u2013195. https:\/\/doi.org\/10.1182\/blood-2014-05-552729","journal-title":"Blood"},{"issue":"4","key":"2957_CR20","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1016\/j.bbmt.2018.12.758","volume":"25","author":"DW Lee","year":"2019","unstructured":"Lee DW, Santomasso BD, Locke FL et al (2019) ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant 25(4):625\u2013638. https:\/\/doi.org\/10.1016\/j.bbmt.2018.12.758","journal-title":"Biol Blood Marrow Transplant"},{"issue":"14","key":"2957_CR21","doi-asserted-by":"publisher","first-page":"1188","DOI":"10.1200\/jco.19.00010","volume":"37","author":"JP Leonard","year":"2019","unstructured":"Leonard JP, Trneny M, Izutsu K et al (2019) AUGMENT: A Phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. J Clin Oncol 37(14):1188\u20131199. https:\/\/doi.org\/10.1200\/jco.19.00010","journal-title":"J Clin Oncol"}],"container-title":["International Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-025-02957-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10147-025-02957-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-025-02957-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T17:04:51Z","timestamp":1771952691000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10147-025-02957-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,12]]},"references-count":21,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["2957"],"URL":"https:\/\/doi.org\/10.1007\/s10147-025-02957-1","relation":{},"ISSN":["1341-9625","1437-7772"],"issn-type":[{"value":"1341-9625","type":"print"},{"value":"1437-7772","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,12]]},"assertion":[{"value":"29 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 December 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 January 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"SM: Honoraria: Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd, Genmab, Gilead Science; KI: AstraZeneca, AbbVie, Incyte, Bristol-Myers Squibb, Novartis, Daiichi Sankyo, Chugai Pharmaceutical Co., BeiGene, Genmab, LOXO Oncology, Regeneron; YM: No disclosures to report; TK: Honoraria: Chugai Pharmaceutical Co., Ltd, Janssen, Ono Pharmaceuticals, AbbVie, Genmab, AstraZeneca, BeOne; JK: Honoraria: BeOne, Janssen, Kyowa Kirin, Bristol-Myers Squibb, Asahi Kasei, Astellas, AstraZeneca, Eisai, Pfizer, Otsuka Pharmaceutical, Sanofi, Ono Pharmaceutical, Novartis, AbbVie, Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo, Nippon Shinyaku, Genmab, Amgen. Fees for promotional materials: Chugai Pharmaceutical Co., Ltd, Eisai, Pfizer. Research funding: Taiho Pharmaceutical, Chugai Pharmaceutical Co., Ltd, Mochida Pharmaceutical, Asahi Kasei, Janssen, AbbVie, MSD, Bristol-Myers Squibb, Pfizer, Otsuka Pharmaceutical, Takeda Pharmaceutical, Ono Pharmaceutical, BeOne, and Regeneron; NK: Honoraria: Chugai Pharmaceutical Co., Ltd; NF: Honoraria: Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd; KS: Honoraria: Chugai Pharmaceutical Co., Ltd, Eli Lilly, AbbVie, BeiGene, Genmab, Daiichi Sankyo, Ohara, Takeda, Kyowa Kirin, CSL Behring, Eisai, Janssen, Bristol-Myers Squibb, Nippon Shinyaku, Ono, Gilead, Novartis, Incyte, Meiji Seika Pharma, Mundi Pharma, Sanofi, Taisho, IQVIA, Asahi Kasei. Research funding: Kyowa Kirin; CM: Employee of Chugai Pharmaceutical Co., Ltd. Stock ownership: Chugai Pharmaceutical Co., Ltd; AK: Employee of Chugai Pharmaceutical Co. Ltd; TM: Employee of Chugai Pharmaceutical Co., Ltd. Stock ownership: Chugai Pharmaceutical Co., Ltd. Patent licensing fees: Chugai Pharmaceutical Co., Ltd; DM: Honoraria: Ono, Nippon Shinyaku, Janssen, Mundi Pharma, Eisai, Chugai Pharmaceutical Co., Ltd, Kyowa Kirin, MSD, Sanofi, Symbio, Takeda, AbbVie, AstraZeneca, Bristol-Myers Squibb, Genmab, Novartis, Pfizer. Research funding: Ono, Janssen, Eisai, Chugai Pharmaceutical Co., Ltd, Kyowa Kirin, MSD, Sanofi, Symbio, Takeda, AbbVie, AstraZeneca, Bristol-Myers Squibb, Genmab, Novartis, Otsuka, Taiho, Pfizer, Astellas.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}