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

• Type of Material: Article
• Authors: Sagar Lonial, Emory University; Hans C Lee, The University of Texas MD Anderson Cancer Center; Ashraf Badros, University of Maryland at Baltimore; Suzanne Trudel, Princess Margaret Cancer Center; Ajay Nooka, Emory University; Ajai Chari, Icahn School of Medicine at Mount Sinai; Al-Ola Abdallah, University of Kansas; Natalie Callander, University of Wisconsin, Madison; Douglas Sborov, University of Utah; Attaya Suvannasankha, Indiana University; Katja Weisel, University Medical Center of Hamburg‐Eppendorf; Peter M Voorhees, Atrium Health; Lynsey Womersley, GlaxoSmithKline; January Baron, GlaxoSmithKline; Trisha Piontek, GlaxoSmithKline; Eric Lewis, GlaxoSmithKline; Joanna Opalinska, GlaxoSmithKline; Ira Gupta, GlaxoSmithKline; Adam D Cohen, University of Pennsylvania
• Language: English
• Date: 2021-07-27
• Publisher: WILEY
• Publication Version: Final Published Version
• Copyright Statement: © 2021 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1002/cncr.33809
• Title of Journal or Parent Work: CANCER
• Volume: 127
• Issue: 22
• Start Page: 4198
• End Page: 4212
• Grant/Funding Information: This study was funded by GlaxoSmithKline. GlaxoSmithKline contributed to study design, implementation, data collection, interpretation, and analysis. Medical writing support was funded by GlaxoSmithKline.
• Keywords: multiple myeloma; Science & Technology; GROWTH; OPEN-LABEL; Oncology; Life Sciences & Biomedicine; SURVIVAL; monoclonal antibody; clinical activity; antibody-drug conjugate; B-cell maturation antigen; SELINEXOR; DEXAMETHASONE
• Research Categories: Health Sciences, Oncology

Abstract

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.