DREAMM-6: Safety and tolerability of belantamab mafodotin in combination with bortezomib/dexamethasone in relapsed/refractory multiple myeloma (RRMM)
| Autor: | Ira Gupta, Geraldine Ferron-Brady, Rafat Abonour, Hang Quach, Maria-Victoria Mateos, Adam Forbes, Amit Khot, Mala K. Talekar, Alan Tan, Katarina Luptakova, Steve Frey, Bikramjit Chopra, Rakesh Popat, Keith Stockerl-Goldstein, Jacqueline Davidge, Anne Yeakey, Ajay K. Nooka, Rachel Rogers |
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| Rok vydání: | 2020 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Antigen Targeting business.industry medicine.disease Immunoconjugate 03 medical and health sciences 0302 clinical medicine Tolerability 030220 oncology & carcinogenesis Internal medicine Relapsed refractory medicine In patient business Bortezomib/dexamethasone Multiple myeloma 030215 immunology |
| Zdroj: | Journal of Clinical Oncology. 38:8502-8502 |
| ISSN: | 1527-7755 0732-183X 0352-5678 |
| Popis: | 8502 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 . |
| Databáze: | OpenAIRE |
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