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Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth
The randomized phase III ELOQUENT‐2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6084289/ https://www.ncbi.nlm.nih.gov/pubmed/28677826 http://dx.doi.org/10.1111/bjh.14787 |
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author | Dimopoulos, Meletios A. Lonial, Sagar White, Darrell Moreau, Philippe Palumbo, Antonio San‐Miguel, Jesus Shpilberg, Ofer Anderson, Kenneth Grosicki, Sebastian Spicka, Ivan Walter‐Croneck, Adam Magen, Hila Mateos, Maria‐Victoria Belch, Andrew Reece, Donna Beksac, Meral Bleickardt, Eric Poulart, Valerie Sheng, Jennifer Sy, Oumar Katz, Jessica Singhal, Anil Richardson, Paul |
author_facet | Dimopoulos, Meletios A. Lonial, Sagar White, Darrell Moreau, Philippe Palumbo, Antonio San‐Miguel, Jesus Shpilberg, Ofer Anderson, Kenneth Grosicki, Sebastian Spicka, Ivan Walter‐Croneck, Adam Magen, Hila Mateos, Maria‐Victoria Belch, Andrew Reece, Donna Beksac, Meral Bleickardt, Eric Poulart, Valerie Sheng, Jennifer Sy, Oumar Katz, Jessica Singhal, Anil Richardson, Paul |
author_sort | Dimopoulos, Meletios A. |
collection | PubMed |
description | The randomized phase III ELOQUENT‐2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3‐year follow‐up data. Endpoints included progression‐free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post‐hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M‐protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1‐, 2‐ and 3‐year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M‐protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity. |
format | Online Article Text |
id | pubmed-6084289 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-60842892018-08-16 Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth Dimopoulos, Meletios A. Lonial, Sagar White, Darrell Moreau, Philippe Palumbo, Antonio San‐Miguel, Jesus Shpilberg, Ofer Anderson, Kenneth Grosicki, Sebastian Spicka, Ivan Walter‐Croneck, Adam Magen, Hila Mateos, Maria‐Victoria Belch, Andrew Reece, Donna Beksac, Meral Bleickardt, Eric Poulart, Valerie Sheng, Jennifer Sy, Oumar Katz, Jessica Singhal, Anil Richardson, Paul Br J Haematol Haematological Malignancy The randomized phase III ELOQUENT‐2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3‐year follow‐up data. Endpoints included progression‐free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post‐hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M‐protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1‐, 2‐ and 3‐year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M‐protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity. John Wiley and Sons Inc. 2017-07-05 2017-09 /pmc/articles/PMC6084289/ /pubmed/28677826 http://dx.doi.org/10.1111/bjh.14787 Text en © 2017 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd and British Society for Haematology. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Haematological Malignancy Dimopoulos, Meletios A. Lonial, Sagar White, Darrell Moreau, Philippe Palumbo, Antonio San‐Miguel, Jesus Shpilberg, Ofer Anderson, Kenneth Grosicki, Sebastian Spicka, Ivan Walter‐Croneck, Adam Magen, Hila Mateos, Maria‐Victoria Belch, Andrew Reece, Donna Beksac, Meral Bleickardt, Eric Poulart, Valerie Sheng, Jennifer Sy, Oumar Katz, Jessica Singhal, Anil Richardson, Paul Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
title | Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
title_full | Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
title_fullStr | Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
title_full_unstemmed | Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
title_short | Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
title_sort | elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: eloquent‐2 follow‐up and post‐hoc analyses on progression‐free survival and tumour growth |
topic | Haematological Malignancy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6084289/ https://www.ncbi.nlm.nih.gov/pubmed/28677826 http://dx.doi.org/10.1111/bjh.14787 |
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