Single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma: Final analysis of the DREAMM-2 trial Journal Article
| Authors: | Nooka, A. K.; Cohen, A. D.; Lee, H. C.; Badros, A.; Suvannasankha, A.; Callander, N.; Abdallah, A. O.; Trudel, S.; Chari, A.; Libby, E. N.; Chaudhry, M.; Hultcrantz, M.; Kortüm, K. M.; Popat, R.; Sborov, D.; Hakim, S.; Lewis, E.; Gorsh, B.; Bhushan, B.; McKeown, A.; Gupta, I.; Opalinska, J.; Richardson, P. G.; Lonial, S. |
| Article Title: | Single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma: Final analysis of the DREAMM-2 trial |
| Abstract: | Background: Patients with relapsed/refractory multiple myeloma (RRMM) have a high unmet treatment need. Belantamab mafodotin (belamaf), a first-in-class, B-cell maturation antigen-binding antibody-drug conjugate, eliminates myeloma cells through direct cell killing and an anti-myeloma immune response. Methods: DREAMM-2 (NCT03525678) was a phase 2, two-arm, open-label trial in patients with heavily pretreated RRMM who had three or more prior therapies, were refractory to an immunomodulatory agent and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 monoclonal antibody. Belamaf was given at 2.5 or 3.4 mg/kg every 3 weeks. The primary end point was overall response rate (ORR); secondary end points included progression-free survival (PFS), overall survival (OS), safety, ocular symptoms, and health-related quality of life (HRQOL). Results: This final analysis (cutoff date, March 31, 2022), N = 223, with median follow-up of 12.5 and 13.8 months, demonstrated an ORR of 32% and 35%, median PFS of 2.8 and 3.9 months, and median OS of 15.3 and 14.0 months in the 2.5 mg/kg and 3.4 mg/kg cohorts, respectively. Median duration of response was 12.5 and 6.2 months. No new safety signals were observed; the most common Grade 3 and 4 adverse events were keratopathy (29% vs. 25%), thrombocytopenia (22% vs. 29%), and anemia (21% vs. 28%). HRQOL outcomes suggest that overall global health status/quality of life, physical and role functioning, and overall disease symptoms were maintained or improved during treatment. Conclusions: This final analysis of DREAMM-2 confirms that in patients with triple-class refractory RRMM, single-agent belamaf results in durable and clinically meaningful responses with a manageable safety profile. © 2023 GSK and The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society. |
| Keywords: | controlled study; treatment outcome; treatment response; major clinical study; overall survival; fatigue; neutropenia; cancer recurrence; diarrhea; drug dose reduction; drug efficacy; drug safety; side effect; treatment duration; follow up; demography; progression free survival; quality of life; multiple myeloma; phase 2 clinical trial; anemia; nausea; thrombocytopenia; vomiting; cohort analysis; hypercalcemia; monoclonal antibody; arthralgia; aspartate aminotransferase blood level; coughing; fever; pneumonia; hypoxia; aspartate aminotransferase; population research; disease severity; heart failure; sepsis; open study; virus infection; headache; dry eye; immunoglobulin deficiency; epistaxis; brain hemorrhage; photophobia; lymphocyte count; heart arrest; upper respiratory tract infection; blurred vision; eye pain; hemophagocytic syndrome; visual acuity; decreased appetite; device infection; patient-reported outcome; acute myeloid leukemia; antibodies, monoclonal, humanized; antibody-drug conjugate; infusion related reaction; blepharitis; clinical activity; intention to treat analysis; humans; human; article; keratopathy; b-cell maturation antigen; european organization for research and treatment of cancer quality of life questionnaire core 30; belantamab mafodotin; device related sepsis; relapsed refractory multiple myeloma |
| Journal Title: | Cancer |
| Volume: | 129 |
| Issue: | 23 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2023-12-01 |
| Start Page: | 3746 |
| End Page: | 3760 |
| Language: | English |
| DOI: | 10.1002/cncr.34987 |
| PUBMED: | 37622738 |
| PROVIDER: | scopus |
| PMCID: | PMC11055177 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
