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Belantamab mafodotin, an anti\u2013B-cell maturation antigen antibody-drug conjugate, was granted accelerated\/conditional approval for patients with RRMM who have received at least 4 prior lines of therapy, based on response rates observed in DREAMM-1\/DREAMM-2. Despite the 41% response rate and durable responses observed with belantamab mafodotin in the Phase III confirmatory DREAMM-3 trial, the marketing license for belantamab mafodotin was later withdrawn from US and European markets when the trial did not meet its primary endpoint of superiority for progression-free survival compared with pomalidomide and dexamethasone. This review reflects on key lessons arising from the clinical journey of belantamab mafodotin in RRMM. It considers how incorporating longer follow-up in DREAMM-3 may have better captured the clinical benefits of belantamab mafodotin, particularly given its multimodal, immune-related mechanism of action with responses deepening over time. A non-inferiority hypothesis may have been more appropriate rather than superiority in the context of a monotherapy versus an active doublet therapy. Further, anticipation of, and planning for, non-proportional hazards arising from response heterogeneity may have mitigated loss of statistical power. With the aim of improving the efficacy of belantamab mafodotin, other Phase III trials in the RRMM development program (DREAMM-7 and DREAMM-8) proceeded to evaluate the synergistic potential of combination regimens in earlier lines of treatment. The aim was to increase the proportion of patients responding to belantamab mafodotin (and thus the likelihood of seeing a clear separation of the progression-free survival curve versus comparator regimens). Protocol amendments reflecting DREAMM-3 learnings could also be implemented prospectively on the combinations trials to optimize the follow-up duration and mitigate risk. The wider implications of the lessons learned for clinical research in RRMM and in earlier treatment settings are discussed.<\/jats:p>","DOI":"10.1038\/s41408-025-01212-0","type":"journal-article","created":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T08:36:07Z","timestamp":1738917367000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["The clinical journey of belantamab mafodotin in relapsed or refractory multiple myeloma: lessons in drug development"],"prefix":"10.1038","volume":"15","author":[{"given":"Pralay","family":"Mukhopadhyay","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hesham A.","family":"Abdullah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna B.","family":"Opalinska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prani","family":"Paka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Richards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9422-6614","authenticated-orcid":false,"given":"Katja","family":"Weisel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Trudel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2390-1218","authenticated-orcid":false,"given":"Maria-Victoria","family":"Mateos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8990-3254","authenticated-orcid":false,"given":"Meletios Athanasios","family":"Dimopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8322-9323","authenticated-orcid":false,"given":"Sagar","family":"Lonial","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,7]]},"reference":[{"key":"1212_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s00277-022-05058-5","volume":"102","author":"B Tanenbaum","year":"2023","unstructured":"Tanenbaum B, Miett T, Patel SA. 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Additionally, we note that the arrow under the DREAMM-7 trial indicating the PCA should be at the end of 2023 rather than at the end of 2022.","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 March 2025","order":8,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":9,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":10,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1038\/s41408-025-01243-7","URL":"https:\/\/doi.org\/10.1038\/s41408-025-01243-7","order":11,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"PM, HAA, JBO, PP, and ER are employees of, and hold financial equities in GSK. SL reports grant funding and personal fees from Celgene and Takeda and personal fees from Novartis, Bristol-Myers Squibb, GSK, Amgen, Merck, and Janssen. KW has received honoraria from Abbvie, Amgen, Adaptive Biotech, AstraZeneca, BMS\/Celgene, Janssen, GSK, Karyopharm, Novartis, Oncopeptides, Pfizer, Roche Pharma, Sanofi, Stemline, and Takeda; consulting or advisory fees from Abbvie, Amgen, Adaptive Biotech, BMS\/Celgene, Janssen, GSK, Karyopharm, Oncopeptides, Pfizer, Roche Pharma, Sanofi, and Takeda, and research funding from Abbvie, Amgen, BMS\/Celgene, Janssen, GSK, and Sanofi. ST has received honoraria from Amgen Canada, Janssen Biotech, Pfizer, and Sanofi; has received grant funding from Amgen Inc, and Bristol-Myers Squibb, and has received research funding from Bristol-Myers Squibb, Genentech, GSK, Janssen, Pfizer and Roche; has acted as a consultant for Bristol-Myers Squibb, GSK, Roche, and Sanofi. MVM has received speakers fees from Amgen, Celgene, GSK, Janssen, Pfizer, Sanofi Pasteur, Takeda Oncology; participated in advisory boards for Celgene, GSK, Janssen, Pfizer, Regeneron Pharmaceuticals, and Sanofi Pasteur, and acted as a consultant for Hoffmann-La Roche, Kite Pharma, and Stemline Therapeutics. MAD has received fees from speaker\u2019s bureau participation from Amgen, Beigene, BMS, Janssen, and Takeda.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"15"}}