DREAMM-6: Safety and tolerability of belantamab mafodotin in combination with bortezomib/dexamethasone in relapsed/refractory multiple myeloma (RRMM).

Authors

null

Ajay K. Nooka

Emory University Hospital, Winship Cancer Institute, Atlanta, GA

Ajay K. Nooka , Keith Stockerl-Goldstein , Hang Quach , Adam Forbes , Maria-Victoria Mateos , Amit Khot , Alan Tan , Rafat Abonour , Bikramjit Chopra , Rachel Rogers , Geraldine Ferron-Brady , Jacqueline Davidge , Steve Frey , Anne Yeakey , Mala Talekar , Katarina Luptakova , Ira Gupta , Rakesh Popat

Organizations

Emory University Hospital, Winship Cancer Institute, Atlanta, GA, Washington University Medical School, St. Louis, MO, University of Melbourne, St. Vincent’s Hospital Melbourne, Melbourne, VIC, Australia, Royal Cornwall Hospital, Truro, United Kingdom, University Hospital of Salamanca/IBSAL/Cancer Research Center- IBMCC (USAL-CSIC), Salamanca, Spain, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, North Melbourne, VIC, Australia, Cancer Treatment Centers of America, University of Arizona College of Medicine, Phoenix, AZ, Queen Elizabeth Hospital, Adelaide, SA, Australia, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom, GlaxoSmithKline, Upper Providence, PA, GlaxoSmithKline, Research Triangle Park, NC, GlaxoSmithKline, Waltham, MA, University College London Hospitals, NHS Foundation Trust, London, United Kingdom

Research Funding

Pharmaceutical/Biotech Company
GlaxoSmithKline

Background: Belantamab mafodotin, a B-cell maturation antigen targeting immunoconjugate, demonstrated clinically meaningful, single-agent activity in patients with heavily pre-treated RRMM refractory to an immunomodulatory agent, a proteasome inhibitor, and refractory and/or intolerant to an anti-CD38 monoclonal antibody (DREAMM-2, NCT03525678, Lancet Oncol.2020). The multimodal mechanism of action and manageable safety profile make belantamab mafodotin a promising candidate for use in different RRMM combination regimens. Methods: DREAMM-6 (NCT03544281) is an ongoing, two-part, two-arm, study evaluating the safety, tolerability, and clinical activity of belantamab mafodotin in combination with bortezomib/dexamethasone (BorDex) and lenalidomide/dexamethasone in patients previously treated with ≥1 prior therapy line. Here, we present data for belantamab mafodotin in combination with BorDex. Part 1 (dose escalation) and Part 2 (dose expansion) evaluated belantamab mafodotin (2.5 and 3.4 mg/kg) administered as SINGLE (Day 1) or SPLIT dose (divided equally on Days 1 and 8) in combination with BorDex. Results: As of February 6, 2020, 52 patients were enrolled: 6 patients were enrolled at 2.5 mg/kg single dose and 7 at 3.4 mg/kg single dosing in Part 1, and 45 patients in Part 2. No dose-limiting toxicities were observed. Corneal events (including keratopathy, blurred vision, and dry eye) and thrombocytopenia were the most frequently reported AEs and were clinically manageable. Conclusions: In DREAMM-6, preliminary data demonstrate that the combination of belantamab mafodotin and BorDex has an acceptable safety profile, with no new safety signals identified. Funding: GlaxoSmithKline (207497). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Clinical trial information: NCT03544281.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Oral Abstract Session

Session Title

Hematologic Malignancies—Plasma Cell Dyscrasia

Track

Hematologic Malignancies

Sub Track

Multiple Myeloma

Clinical Trial Registration Number

NCT03544281

Citation

J Clin Oncol 38: 2020 (suppl; abstr 8502)

DOI

10.1200/JCO.2020.38.15_suppl.8502

Abstract #

8502

Abstract Disclosures