Elotuzumab plus pomalidomide and dexamethasone for relapsed/refractory multiple myeloma: final overall survival analysis from the randomized phase II ELOQUENT-3 trial

Purpose: In the phase II ELOQUENT-3 trial (ClinicalTrials.gov identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM)...

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Detalhes bibliográficos
Autores: Dimopoulos, M.A. (Meletios A.)|||/items/15a77e11-69c3-44a2-8476-eb93bbe8cc0e, Dytfeld, D. (Dominik)|||/items/d446b227-5610-43cf-acef-2a60d17bb0b4, Grosicki, S. (Sebastian)|||/items/b2446ec7-d6ca-4c8f-82c5-e7dbfcdce342, Moreau, P. (Philippe)|||/items/3d8d9f42-9629-4e12-9854-43031d9b6332, Takezako, N. (Naoki)|||/items/bc706772-b24c-4834-b749-435b056013e3, Hori, M. (Mitsuo)|||/items/cbd13a7c-3076-4e09-97b4-73fb3ed4d629, Leleu, X. (Xavier)|||/items/aae83612-eb31-463f-b7e2-59e5d13fc75a, LeBlanc, R. (Richard)|||/items/0e3084f9-b448-423d-a6a6-5c012564d15b, Suzuki, K. (Kenshi)|||/items/cb6c5d44-af9e-40ff-a978-e1d4b4d78437, Raab, M.S. (Marc S.)|||/items/4114a41f-d138-43ce-8ae6-ba41fcdfd207, Richardson, P.G. (Paul G.)|||/items/4a03f76e-f4e1-4490-8091-a79e8ea86861, McKiver, M.P. (Mihaela Popa)|||/items/3858dda4-812c-4152-9f6b-2b7ec9a7db1e, Jou, Y.M. (Ying-Ming)|||/items/e438a096-89b8-4f8c-8f2a-d43325d6c010, Yao, D. (David)|||/items/a7aa4f97-c8e2-4aaf-a848-7fb91316d29b, Das, P. (Prianka)|||/items/ba0a0567-1ccf-4d12-9522-b9c668b8d02d, San-Miguel, J.F. (Jesús F.)|||/items/114f598d-f226-4fa6-aa75-909241328543
Tipo de documento: artigo
Data de publicação:2023
País:España
Recursos:Universidad de Navarra
Repositório:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglês
OAI Identifier:oai:dadun.unav.edu:10171/68028
Acesso em linha:https://hdl.handle.net/10171/68028
Access Level:Acceso aberto
Palavra-chave:Pomalidomide/dexamethasone (EPd)
Elotuzumab
Progression-free survival (PFS)
Pomalidomide/dexamethasone (Pd)
Descrição
Resumo:Purpose: In the phase II ELOQUENT-3 trial (ClinicalTrials.gov identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with lenalidomide and a proteasome inhibitor (PI). Here, we present the final overall survival (OS) results. Methods: Patients with RRMM who had received ¿ 2 prior lines of therapy, with disease refractory to last therapy and either refractory or relapsed and refractory to lenalidomide and a PI were randomly assigned (1:1) to receive EPd or Pd. The primary end point was PFS per investigator assessment. ORR and OS were secondary end points planned to be tested hierarchically. Results: A total of 117 patients were randomly assigned to EPd (n = 60) and Pd (n = 57). Among treated patients (EPd 60, Pd 55), there were 37 (61.7%) deaths in the EPd group and 41 (74.5%) in the Pd group, most commonly because of disease progression (EPd 41.7%, Pd 49.1%). Median (95% CI) OS was significantly improved with EPd (29.8 [22.9 to 45.7] months) versus Pd (17.4 [13.8 to 27.7] months), with a hazard ratio of 0.59 (95% CI, 0.37 to 0.93; P = .0217). OS benefit with EPd was observed in most patient subgroups. The safety profile of EPd was consistent with prior reports with no new safety signals detected. Conclusion: EPd demonstrated a statistically significant improvement in OS versus Pd in patients with RRMM previously treated with lenalidomide and a PI who had disease refractory to last therapy. In this setting, ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and Pd to improve both PFS and OS significantly.

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