Abstracts Clinical Lymphoma, Myeloma & Leukemia September 2023 S504 (MM), HDAC6 inhibitor, proteasome, MHC class I antigen, immunotherapy MM-508 Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma: A Real‑World Observational Study Update Malin Hultcrantz MD, PhD1, David Kleinman MD2, Ravi Vij MD3, Fernando Escalante MD, PhD4, Michel Delforge MD5, Nirali Kotowsky MPH6, Jacopo Bitetti MD7, Natalie Boytsov PhD6, Leena Camadoo-O’Byrne MSc8, Lindsey Powers Happ PhD9, Mujib Rohman MSc10, Guillaume Germain MSc11, Mei Sheng Duh ScD12, François Laliberté MA11, Malena Mahendran MSc11, Ana Urosevic MA11, Hans Lee MD13 1Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. 2Flaum Eye Institute, University of Rochester Medical Center, Rochester, NY, USA. 3Washington University, St. Louis, MO, USA. 4Hematology Department, University Hospital of Leon, Leon, Spain. 5Catholic University of Leuven, Leuven, Belgium. 6GSK, Upper Providence, PA, USA. 7GSK, Zug, Switzerland. 8GSK, Stevenage, United Kingdom. 9GSK, Collegeville, PA, USA. 10GSK, Windsor, United Kingdom. 11Groupe d’Analyse, Lytée, Montreal, Canada. 12Analysis Group, Inc., Boston, MA, USA. 13Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Context: Treating patients with relapsed or refractory multiple myeloma (RRMM) with belantamab mafodotin (belamaf), a B-cell maturation antigen–targeting antibody-drug conjugate, may provide outcomes in clinical practice similar to those of the pivotal phase II DREAMM-2 study (NCT03525678). Objective: To assess real-world occurrence and management of ocular adverse events (AEs) and to evaluate belamaf effectiveness. Design: Retrospective, longitudinal, observational study using the US electronic health record–derived Flatiron Health de-identified database (January 1, 2011–June 30, 2022). Patients: Eligible patients had confirmed MM, initiated belamaf post US Food and Drug Administration approval (August 5, 2020), were ≥18 years of age at first administration date and had chart abstraction data for ocular AEs and treatment effectiveness. Main Outcome Measures: Incidence and mitigation of ocular AEs; tumor response; and Kaplan-Meier estimates of duration of response (DoR), overall survival (OS), and progression-free survival (PFS). Results: Overall, 184 patients were included (mean age, 68.7 years; 64% White; 47% women). Eastern Cooperative Oncology Group (ECOG) status was ≥2 in 28% of patients; 62% received ≥5 prior lines of therapy; 82% were triple-class refractory. Median (interquartile range [IQR]) follow-up: 4.1 (1.9–8.5) months. Among patients with ≥4 months follow-up (n=94), 75% had ≥1 ocular AE (keratopathy, 83%; blurred vision, 66%; dry eye, 37%; keratitis, 23%). Mean (SD) time to first ocular AE: 39 (34) days. Most ocular AEs were managed by therapy hold (69%, of which 73% restarted belamaf) and/or treatment (63%). Median dose hold due to ocular AEs was 43 days (physician-reported keratopathy: mild, 21 days; moderate/severe, 56 days). Overall, 39 patients (21%) had derived tumor responses based on serum free light chain levels (partial response, 74%; very good partial response, 51%). Estimated median DoR, PFS, and OS were 9.1, 4.5, and 7.9 months. The 6-month DoR, PFS, and OS rates were 57%, 46%, and 58%. Conclusions: Belamaf was effective in the real-world setting in patients with RRMM and limited therapy options. The AE profile was consistent with that of DREAMM-2. Despite ocular AEs, which were manageable, most patients continued treatment, suggesting belamaf may fill an unmet need for triple-class–refractory patients with RRMM. Funding: GSK (218905). Keywords: multiple myeloma, relapsed/refractory multiple myeloma, realworld evidence, belantamab mafodotin MM-509 A Phase III, Open‑Label, Randomized Study to Evaluate the Efficacy and Safety of Single‑Agent Belantamab Mafodotin (Belamaf) Compared With Pomalidomide Plus Low‑Dose Dexamethasone (Pd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) (DREAMM‑3) Katja Weisel MD1, Vania T. M. Hungria MD, PhD2, Atanas Radinoff MD3, Sosana Delimpasi MD4, Mikala Gabor MD, PhD5, Tamas Masszi MD, PhD6, Jian Li MD7, Marcelo Capra MD8, Morio Matsumoto MD9, Neal Sule MBBS, MD10, Mary Li PharmD10, Astrid McKeown PhD11, Wei He PhD12, Shelley Bright MPA10, Brooke Currie MPH13, Julia Boyle PhD14, Joanna Opalinska MD, PhD10, Meletios Athanasios Dimopoulos MD15 1University Medical Center of Hamburg-Eppendorf, Hamburg, Germany. 2Department of Hematology, Clinica São Germano, São Paulo, Brazil. 3University Hospital “St Ivan Rilski” EAD, Sofia, Bulgaria. 4General Hospital Evangelismos, Athens, Greece. 5South Pest Central Hospital, National Institute for Haematology and Infectious Diseases, Budapest, Hungary. 6Department of Internal Medicine and Haematology, Semmelweis University, Budapest, Hungary. 7Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 8Centro Integrado de Hematologia e Oncologia, Hospital Mãe de Deus, Porto Alegre, Brazil. 9National Hospital Organization, Shibukawa Medical Center, Shibukawa, Japan. 10GSK, Upper Providence, PA, USA. 11GSK, Stevenage, England, United Kingdom. 12GSK, Waltham, MA, USA. 13GSK, Rockville, MD, USA. 14GSK, London, United Kingdom. 15National and Kapodistrian University of Athens School of Medicine, Athens, Greece Context: Belamaf, an antibody-drug conjugate targeting B-cell maturation antigen, induced deep and durable responses in patients with RRMM in the DREAMM-2 trial (NCT03525678). Objective: To evaluate single-agent belamaf vs the doublet Pd in adults with RRMM (second relapse or later) in the phase III, openlabel, randomized, multicenter DREAMM-3 trial (NCT04162210). Design: Patients were randomized (2:1) to belamaf 2.5 mg/kg
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