• Vania Hungria, Pawel Robak, Marek Hus, Vera Zherebtsova, Christopher Ward, P Joy Ho, Ana Carolina Ribas de Almeida, Roman Hajek, Kihyun Kim, Sebastian Grosicki, Hanlon Sia, Adam Bryant, Pitombeira de LacerdaMarceloM0000-0001-5554-7167From Clinica São Germano (V.H.) and Hospital das Clínicas and Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo (G.A.M.), São Paulo, Centro de Pesquisa e Ensino em Saúde de Santa Catarin,, Aparecida MartinezGraciaGFrom Clinica São Germano (V.H.) and Hospital das Clínicas and Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo (G.A.M.), São Paulo, Centro de Pesquisa e Ensino em Saúde de Santa Catarin, Florianópolis (A.C.R.A, Anna Maria Sureda Balarí, Irwindeep Sandhu, Claudio Cerchione, Peter Ganly, Meletios Dimopoulos, Chengcheng Fu, Mamta Garg, Al-Ola Abdallah, Albert Oriol, Moshe E Gatt, Michele Cavo, Robert Rifkin, Tomoaki Fujisaki, Michał Mielnik, Nick Pirooz, Astrid McKeown, Simon McNamara, Xiangdong Zhou, Maureen Nichols, Eric Lewis, Rachel Rogers, Hena Baig, Lydia Eccersley, Sumita Roy-Ghanta, Joanna Opalinska, María-Victoria Mateos, and DREAMM-7 Investigators.
• From Clinica São Germano (V.H.) and Hospital das Clínicas and Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo (G.A.M.), São Paulo, Centro de Pesquisa e Ensino em Saúde de Santa Catarin, Florianópolis (A.C.R.A.), and Universidade da Região de Joinville and Centro de Hematologia e Oncologia, Joinville (M.P.L.) - all in Brazil; Medical University of Lodz, Lodz (P.R.), Medical University of Lublin, Lublin (M.H., M.M.), and the Medical University of Silesia, Katowice (S.G.) - all in Poland; Gorodskaya Klinicheskaya Bol'nitsa Imeni Saint Petersburg Botkina, Moscow (V.Z.); the Royal North Shore Hospital (C.W.) and Liverpool Hospital (A.B.), Sydney, Royal Prince Alfred Hospital and University of Sydney, Camperdown, NSW (P.J.H.), and Pindara Private Hospital, Gold Coast, QLD (H.S.) - all in Australia; the Department of Hematooncology, University Hospital Ostrava, and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic (R.H.); Sungkyunkwan University and Samsung Medical Center, Seoul, South Korea (K.K.); Institut Català d'Oncologia-L'Hospitalet de Llobregat-Barcelona, Barcelona (A.M.S.B.), Institut Català d'Oncologia and Josep Carreras Research Institute, Hospital Germans Trias i Pujol, Badalona (A.O.), and Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Centro de Investigación del Cáncer, Ciberonc, Salamanca (M.-V.M.) - all in Spain; Cross Cancer Institute, Edmonton (I.S.), and GSK, Mississauga (H.B.) - both in Canada; the Hematology Unit, Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori," IRST IRCCS, Meldola (C.C.), and IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Bologna (M.C.) - both in Italy; Christchurch Hospital, Christchurch, New Zealand (P.G.); National and Kapodistrian University of Athens, Athens (M.D.); the First Affiliated Hospital of Soochow University, Suzhou, China (C.F.); University Hospitals of Leicester NHS Trust, Leicester (M.G.), GSK, Stevenage (A.M., S.M.), and GSK, London (L.E.) - all in the United Kingdom; University of Kansas Cancer Center, Fairway (A.-O.A.); the Department of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel (M.E.G.); Rocky Mountain Cancer Centers-Denver-Midtown, Denver (R. Rifkin); Matsuyama Red Cross Hospital, Matsuyama, Japan (T.F.); GSK, Upper Providence, PA (N.P., X.Z., R. Rogers, S.R.-G., J.O.); and GSK, Durham (M.N.), and GSK, Research Triangle Park (E.L.) - both in North Carolina.
• N. Engl. J. Med. 2024 Aug 1; 391 (5): 393407393-407.

BackgroundBelantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further evaluation of the agent in combination with standard-care therapies.MethodsIn this phase 3, open-label, randomized trial, we evaluated belantamab mafodotin, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary end point was progression-free survival. Key secondary end points were overall survival, response duration, and minimal residual disease (MRD)-negative status.ResultsIn total, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group and 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. An analysis of the restricted mean response duration favored BVd over DVd (P<0.001). A complete response or better plus MRD-negative status occurred in 25% of the patients in the BVd group and 10% of those in the DVd group. Grade 3 or higher adverse events occurred in 95% of the patients in the BVd group and 78% of those in the DVd group. Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%); such events were managed with dose modifications, and events of worsening visual acuity mostly resolved.ConclusionsAs compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy. Most patients had grade 3 or higher adverse events. (Funded by GSK; DREAMM-7 ClinicalTrials.gov number, NCT04246047; EudraCT number, 2018-003993-29.).Copyright © 2024 Massachusetts Medical Society.

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