Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study

dc.contributor.authorLonial, Sagar
dc.contributor.authorLee, Hans C.
dc.contributor.authorBadros, Ashraf
dc.contributor.authorTrudel, Suzanne
dc.contributor.authorNooka, Ajay K.
dc.contributor.authorChari, Ajai
dc.contributor.authorAbdallah, Al-Ola
dc.contributor.authorCallander, Natalie
dc.contributor.authorSborov, Douglas
dc.contributor.authorSuvannasankha, Attaya
dc.contributor.authorWeisel, Katja
dc.contributor.authorVoorhees, Peter M.
dc.contributor.authorWomersley, Lynsey
dc.contributor.authorBaron, January
dc.contributor.authorPiontek, Trisha
dc.contributor.authorLewis, Eric
dc.contributor.authorOpalinska, Joanna
dc.contributor.authorGupta, Ira
dc.contributor.authorCohen, Adam D.
dc.contributor.departmentMedicine, School of Medicine
dc.date.accessioned2024-04-02T14:27:22Z
dc.date.available2024-04-02T14:27:22Z
dc.date.issued2021
dc.description.abstractBackground: On the basis of the DREAMM-2 study (ClinicalTrials.gov identifier NCT03525678), single-agent belantamab mafodotin (belamaf) was approved for patients with relapsed or refractory multiple myeloma (RRMM) who received ≥4 prior therapies, including anti-CD38 therapy. The authors investigated longer term efficacy and safety outcomes in DREAMM-2 after 13 months of follow-up among patients who received belamaf 2.5 mg/kg. Methods: DREAMM-2 is an ongoing, phase 2, open-label, 2-arm study investigating belamaf (2.5 or 3.4 mg/kg) in patients with RRMM who had disease progression after ≥3 lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors and refractory and/or intolerant to an anti-CD38 therapy. The primary outcome was the proportion of patients that achieved an overall response, assessed by an independent review committee. Results: As of January 31, 2020, 10% of patients still received belamaf 2.5 mg/kg. Thirty-one of 97 patients (32%; 97.5% confidence interval [CI], 21.7%-43.6%) achieved an overall response, and 18 responders achieved a very good partial response or better. Median estimated duration of response, overall survival, and progression-free survival were 11.0 months (95% CI, 4.2 months to not reached), 13.7 months (95% CI, 9.9 months to not reached), and 2.8 months (95% CI, 1.6-3.6 months), respectively. Response and survival outcomes in patients who had high-risk cytogenetics or renal impairment were consistent with outcomes in the overall population. Outcomes were poorer in patients with extramedullary disease. In patients who had a clinical response and prolonged dose delays (>63 days; mainly because of corneal events), 88% maintained or deepened responses during their first prolonged dose delay. Overall, there were no new safety signals during this follow-up. Conclusions: Extended follow-up confirms sustained clinical activity without new safety signals with belamaf in this heavily pretreated patient population with RRMM.
dc.eprint.versionFinal published version
dc.identifier.citationLonial S, Lee HC, Badros A, et al. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021;127(22):4198-4212. doi:10.1002/cncr.33809
dc.identifier.urihttps://hdl.handle.net/1805/39691
dc.language.isoen_US
dc.publisherWiley
dc.relation.isversionof10.1002/cncr.33809
dc.relation.journalCancer
dc.rightsAttribution-NonCommercial 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.sourcePMC
dc.subjectB-cell maturation antigen
dc.subjectAntibody-drug conjugate
dc.subjectClinical activity
dc.subjectMonoclonal antibody
dc.subjectMultiple myeloma
dc.titleLonger term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study
dc.typeArticle
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