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
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Background: 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.
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The response rate and DOR in MagnetisMM-3 were favorable to belantamab mafodotin (ORR 32%, median DOR 11.0 months and median PFS 2.8 months) after a median follow-up of 12.4 months.
“and favorable to the BCMA-targeting antibody–drug conjugate, belantamab mafodotin (ORR 32%, median DOR 11.0 months and median PFS 2.8 months) after a median follow-up of 12.4 months4,9,19,23.”
From Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results (2023) · cites this paper as [23]
The Abstract Results and Discussion report the belantamab mafodotin outcomes exactly: ORR 32%, median DOR 11.0 months, and median PFS 2.8 months. The paper identifies these as DREAMM-2 results at a 13-month follow-up, not MagnetisMM-3 results; our copy does not substantiate the stated median follow-up of 12.4 months. (LLM, conf=0.88)
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- [20]GlaxoSmithKline (GSK). GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma. Accessed December 14, 2020. https://www.gsk.com/en‐gb/media/press‐releases/gsk‐announces‐european‐medicines‐agency‐ema‐accepted‐marketing‐authorisation‐application‐for‐belantamab‐mafodotin‐for‐the‐treatment‐of‐relapsed‐or‐refractory‐multiple‐myeloma/
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Self-citation
- Authors
- Lonial, S., Lee, H. C., Badros, A., Trudel, S., Nooka, A. K., Chari, A., Abdallah, A., Callander, N., Sborov, D., Suvannasankha, A., Weisel, K., Voorhees, P. M., Womersley, L., Baron, J., Piontek, T., Lewis, E., Opalinska, J., Gupta, I., & Cohen, A. D.
- Affiliations
- Emory University (US)
- The University of Texas MD Anderson Cancer Center (US)
- University of Maryland, Baltimore (US)
- Princess Margaret Cancer Centre (CA)
- Icahn School of Medicine at Mount Sinai (US)
- University of Kansas (US)
- University of Wisconsin–Madison (US)
- Huntsman Cancer Institute (US)
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center (US)
- University Medical Center Hamburg-Eppendorf (DE)
- Levine Cancer Institute (US)
- GlaxoSmithKline (United Kingdom) (GB)
- GlaxoSmithKline (United States) (US)
- GlaxoSmithKline Upper Providence Pennsylvania
- Abramson Cancer Center (US)
- Corresponding author
- Lonial, Sagar
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2021-07-27
- Volume
- 127
- Issue
- 22
- Pages
- 4198-4212
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- PMC
- PMC8597112
- OpenAlex
- W3183441818
- Cited by
- 144
- References
- 33
- Citations by year
- 2026: 7 · 2025: 17 · 2024: 22 · 2023: 45 · 2022: 44 · 2021: 8
- FWCI
- 19.44
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Cancer (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion, cc-by-nc)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc)
- Funders
- GlaxoSmithKline (205678)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- belantamab mafodotin, relapsed/refractory multiple myeloma, monotherapy, anti-CD38 therapy, overall response rate, duration of response, overall survival, progression-free survival, dose delay, corneal toxicity, extramedullary disease, high-risk cytogenetics, renal dysfunction, long-term safety
- MeSH terms
- Progression-Free Survival, Follow-Up Studies, Humans, Multiple Myeloma, Antibodies, Monoclonal, Humanized
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