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Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma

Triple‐class‐refractory multiple myeloma (MM) describes MM refractory to proteasome inhibitors, immunomodulatory agents, and anti‐CD38 monoclonal antibodies. In the Phase IIb STORM study (NCT02336815), oral selinexor plus low‐dose dexamethasone (Sel‐dex) demonstrated a 26.2% overall response rate in...

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Autores principales: Richardson, Paul G., Jagannath, Sundar, Chari, Ajai, Vogl, Dan T., Dimopoulos, Meletios A., Moreau, Philippe, Dingli, David, Wei, Lee‐Jen, Richter, Joshua, Biran, Noa, Siegel, David, Reichmann, William, Li, Lingling, Tang, Shijie, Saint‐Martin, Jean‐Richard, Joshi, Anita, Kauffman, Michael, Shah, Jatin, Shacham, Sharon, Lonial, Sagar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9175889/
https://www.ncbi.nlm.nih.gov/pubmed/35846096
http://dx.doi.org/10.1002/jha2.120
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author Richardson, Paul G.
Jagannath, Sundar
Chari, Ajai
Vogl, Dan T.
Dimopoulos, Meletios A.
Moreau, Philippe
Dingli, David
Wei, Lee‐Jen
Richter, Joshua
Biran, Noa
Siegel, David
Reichmann, William
Li, Lingling
Tang, Shijie
Saint‐Martin, Jean‐Richard
Joshi, Anita
Kauffman, Michael
Shah, Jatin
Shacham, Sharon
Lonial, Sagar
author_facet Richardson, Paul G.
Jagannath, Sundar
Chari, Ajai
Vogl, Dan T.
Dimopoulos, Meletios A.
Moreau, Philippe
Dingli, David
Wei, Lee‐Jen
Richter, Joshua
Biran, Noa
Siegel, David
Reichmann, William
Li, Lingling
Tang, Shijie
Saint‐Martin, Jean‐Richard
Joshi, Anita
Kauffman, Michael
Shah, Jatin
Shacham, Sharon
Lonial, Sagar
author_sort Richardson, Paul G.
collection PubMed
description Triple‐class‐refractory multiple myeloma (MM) describes MM refractory to proteasome inhibitors, immunomodulatory agents, and anti‐CD38 monoclonal antibodies. In the Phase IIb STORM study (NCT02336815), oral selinexor plus low‐dose dexamethasone (Sel‐dex) demonstrated a 26.2% overall response rate in triple‐class‐refractory MM. Here, we compare overall survival (OS) of 122 patients with triple‐class‐refractory MM who received Sel‐dex in STORM Part 2 with that of 64 similar patients treated with other available therapies in a Flatiron Health Analytic Database (FHAD) cohort. OS from the date that the patients’ MM became triple‐class‐refractory was longer in STORM versus FHAD, with an unadjusted hazard ratio (HR) of 0.43 (P =  .0002; adjusted HR 0.35 [P  =  .011]). In a subset analysis of highly resistant patients receiving further therapies after their MM first became at least triple‐class‐refractory (i.e., who received Sel‐dex in STORM, n = 64, and non‐Sel‐dex in FHAD, n = 36), the OS was significantly longer in STORM with an unadjusted HR of 0.52 (P = .0331; adjusted HR 0.33 [P = .041]). Within the limits of this analysis, the OS of patients with at least triple‐class‐refractory MM was significantly better with Sel‐dex versus available therapies, suggesting that Sel‐dex may be associated with a meaningful OS benefit in these patients.
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spelling pubmed-91758892022-07-14 Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma Richardson, Paul G. Jagannath, Sundar Chari, Ajai Vogl, Dan T. Dimopoulos, Meletios A. Moreau, Philippe Dingli, David Wei, Lee‐Jen Richter, Joshua Biran, Noa Siegel, David Reichmann, William Li, Lingling Tang, Shijie Saint‐Martin, Jean‐Richard Joshi, Anita Kauffman, Michael Shah, Jatin Shacham, Sharon Lonial, Sagar EJHaem Haematologic Malignancy–Plasma Cell Triple‐class‐refractory multiple myeloma (MM) describes MM refractory to proteasome inhibitors, immunomodulatory agents, and anti‐CD38 monoclonal antibodies. In the Phase IIb STORM study (NCT02336815), oral selinexor plus low‐dose dexamethasone (Sel‐dex) demonstrated a 26.2% overall response rate in triple‐class‐refractory MM. Here, we compare overall survival (OS) of 122 patients with triple‐class‐refractory MM who received Sel‐dex in STORM Part 2 with that of 64 similar patients treated with other available therapies in a Flatiron Health Analytic Database (FHAD) cohort. OS from the date that the patients’ MM became triple‐class‐refractory was longer in STORM versus FHAD, with an unadjusted hazard ratio (HR) of 0.43 (P =  .0002; adjusted HR 0.35 [P  =  .011]). In a subset analysis of highly resistant patients receiving further therapies after their MM first became at least triple‐class‐refractory (i.e., who received Sel‐dex in STORM, n = 64, and non‐Sel‐dex in FHAD, n = 36), the OS was significantly longer in STORM with an unadjusted HR of 0.52 (P = .0331; adjusted HR 0.33 [P = .041]). Within the limits of this analysis, the OS of patients with at least triple‐class‐refractory MM was significantly better with Sel‐dex versus available therapies, suggesting that Sel‐dex may be associated with a meaningful OS benefit in these patients. John Wiley and Sons Inc. 2020-11-25 /pmc/articles/PMC9175889/ /pubmed/35846096 http://dx.doi.org/10.1002/jha2.120 Text en © 2020 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Haematologic Malignancy–Plasma Cell
Richardson, Paul G.
Jagannath, Sundar
Chari, Ajai
Vogl, Dan T.
Dimopoulos, Meletios A.
Moreau, Philippe
Dingli, David
Wei, Lee‐Jen
Richter, Joshua
Biran, Noa
Siegel, David
Reichmann, William
Li, Lingling
Tang, Shijie
Saint‐Martin, Jean‐Richard
Joshi, Anita
Kauffman, Michael
Shah, Jatin
Shacham, Sharon
Lonial, Sagar
Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
title Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
title_full Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
title_fullStr Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
title_full_unstemmed Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
title_short Overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
title_sort overall survival with oral selinexor plus low‐dose dexamethasone versus real‐world therapy in triple‐class‐refractory multiple myeloma
topic Haematologic Malignancy–Plasma Cell
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9175889/
https://www.ncbi.nlm.nih.gov/pubmed/35846096
http://dx.doi.org/10.1002/jha2.120
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