Cargando…

Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR

In relapsed and/or refractory multiple myeloma, daratumumab reduced the risk of progression or death by > 60% in POLLUX (daratumumab/lenalidomide/dexamethasone [D-Rd]) and CASTOR (daratumumab/bortezomib/dexamethasone [D-Vd]). Minimal residual disease (MRD) is a sensitive measure of disease contro...

Descripción completa

Detalles Bibliográficos
Autores principales: Avet-Loiseau, Hervé, San-Miguel, Jesus, Casneuf, Tineke, Iida, Shinsuke, Lonial, Sagar, Usmani, Saad Z., Spencer, Andrew, Moreau, Philippe, Plesner, Torben, Weisel, Katja, Ukropec, Jon, Chiu, Christopher, Trivedi, Sonali, Amin, Himal, Krevvata, Maria, Ramaswami, Priya, Qin, Xiang, Qi, Mia, Sun, Steven, Qi, Ming, Kobos, Rachel, Bahlis, Nizar J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078259/
https://www.ncbi.nlm.nih.gov/pubmed/33513030
http://dx.doi.org/10.1200/JCO.20.01814
_version_ 1783685022166810624
author Avet-Loiseau, Hervé
San-Miguel, Jesus
Casneuf, Tineke
Iida, Shinsuke
Lonial, Sagar
Usmani, Saad Z.
Spencer, Andrew
Moreau, Philippe
Plesner, Torben
Weisel, Katja
Ukropec, Jon
Chiu, Christopher
Trivedi, Sonali
Amin, Himal
Krevvata, Maria
Ramaswami, Priya
Qin, Xiang
Qi, Mia
Sun, Steven
Qi, Ming
Kobos, Rachel
Bahlis, Nizar J.
author_facet Avet-Loiseau, Hervé
San-Miguel, Jesus
Casneuf, Tineke
Iida, Shinsuke
Lonial, Sagar
Usmani, Saad Z.
Spencer, Andrew
Moreau, Philippe
Plesner, Torben
Weisel, Katja
Ukropec, Jon
Chiu, Christopher
Trivedi, Sonali
Amin, Himal
Krevvata, Maria
Ramaswami, Priya
Qin, Xiang
Qi, Mia
Sun, Steven
Qi, Ming
Kobos, Rachel
Bahlis, Nizar J.
author_sort Avet-Loiseau, Hervé
collection PubMed
description In relapsed and/or refractory multiple myeloma, daratumumab reduced the risk of progression or death by > 60% in POLLUX (daratumumab/lenalidomide/dexamethasone [D-Rd]) and CASTOR (daratumumab/bortezomib/dexamethasone [D-Vd]). Minimal residual disease (MRD) is a sensitive measure of disease control. Sustained MRD negativity and outcomes were evaluated in these studies. METHODS: MRD was assessed via next-generation sequencing (10(−5)) at suspected complete response (CR), 3 and 6 months following confirmed CR (POLLUX), 6 and 12 months following the first dose (CASTOR), and every 12 months post-CR in both studies. Sustained MRD negativity (≥ 6 or ≥ 12 months) was evaluated in the intention-to-treat (ITT) and ≥ CR populations. RESULTS: The median follow-up was 54.8 months in POLLUX and 50.2 months in CASTOR. In the ITT population, MRD-negativity rates were 32.5% versus 6.7% for D-Rd versus lenalidomide and dexamethasone (Rd) and 15.1% versus 1.6% for D-Vd versus bortezomib and dexamethasone (Vd; both P < .0001). Higher MRD negativity rates were achieved in ≥ CR patients in POLLUX (D-Rd, 57.4%; Rd, 29.2%; P = .0001) and CASTOR (D-Vd, 52.8%; Vd, 17.4%; P = .0035). More patients in the ITT population achieved sustained MRD negativity ≥ 6 months with D-Rd versus Rd (20.3% v 2.1%; P < .0001) and D-Vd versus Vd (10.4% v 1.2%; P < .0001), and ≥ 12 months with D-Rd versus Rd (16.1% v 1.4%; P < .0001) and D-Vd versus Vd (6.8% v 0%). Similar results for sustained MRD negativity were observed among ≥ CR patients. More patients in the daratumumab-containing arms achieved MRD negativity and sustained MRD negativity, which were associated with prolonged progression-free survival. CONCLUSION: Daratumumab-based combinations induce higher rates of sustained MRD negativity versus standard of care, which are associated with durable remissions and prolonged clinical outcomes.
format Online
Article
Text
id pubmed-8078259
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Wolters Kluwer Health
record_format MEDLINE/PubMed
spelling pubmed-80782592022-04-01 Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR Avet-Loiseau, Hervé San-Miguel, Jesus Casneuf, Tineke Iida, Shinsuke Lonial, Sagar Usmani, Saad Z. Spencer, Andrew Moreau, Philippe Plesner, Torben Weisel, Katja Ukropec, Jon Chiu, Christopher Trivedi, Sonali Amin, Himal Krevvata, Maria Ramaswami, Priya Qin, Xiang Qi, Mia Sun, Steven Qi, Ming Kobos, Rachel Bahlis, Nizar J. J Clin Oncol ORIGINAL REPORTS In relapsed and/or refractory multiple myeloma, daratumumab reduced the risk of progression or death by > 60% in POLLUX (daratumumab/lenalidomide/dexamethasone [D-Rd]) and CASTOR (daratumumab/bortezomib/dexamethasone [D-Vd]). Minimal residual disease (MRD) is a sensitive measure of disease control. Sustained MRD negativity and outcomes were evaluated in these studies. METHODS: MRD was assessed via next-generation sequencing (10(−5)) at suspected complete response (CR), 3 and 6 months following confirmed CR (POLLUX), 6 and 12 months following the first dose (CASTOR), and every 12 months post-CR in both studies. Sustained MRD negativity (≥ 6 or ≥ 12 months) was evaluated in the intention-to-treat (ITT) and ≥ CR populations. RESULTS: The median follow-up was 54.8 months in POLLUX and 50.2 months in CASTOR. In the ITT population, MRD-negativity rates were 32.5% versus 6.7% for D-Rd versus lenalidomide and dexamethasone (Rd) and 15.1% versus 1.6% for D-Vd versus bortezomib and dexamethasone (Vd; both P < .0001). Higher MRD negativity rates were achieved in ≥ CR patients in POLLUX (D-Rd, 57.4%; Rd, 29.2%; P = .0001) and CASTOR (D-Vd, 52.8%; Vd, 17.4%; P = .0035). More patients in the ITT population achieved sustained MRD negativity ≥ 6 months with D-Rd versus Rd (20.3% v 2.1%; P < .0001) and D-Vd versus Vd (10.4% v 1.2%; P < .0001), and ≥ 12 months with D-Rd versus Rd (16.1% v 1.4%; P < .0001) and D-Vd versus Vd (6.8% v 0%). Similar results for sustained MRD negativity were observed among ≥ CR patients. More patients in the daratumumab-containing arms achieved MRD negativity and sustained MRD negativity, which were associated with prolonged progression-free survival. CONCLUSION: Daratumumab-based combinations induce higher rates of sustained MRD negativity versus standard of care, which are associated with durable remissions and prolonged clinical outcomes. Wolters Kluwer Health 2021-04-01 2021-01-29 /pmc/articles/PMC8078259/ /pubmed/33513030 http://dx.doi.org/10.1200/JCO.20.01814 Text en © 2021 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle ORIGINAL REPORTS
Avet-Loiseau, Hervé
San-Miguel, Jesus
Casneuf, Tineke
Iida, Shinsuke
Lonial, Sagar
Usmani, Saad Z.
Spencer, Andrew
Moreau, Philippe
Plesner, Torben
Weisel, Katja
Ukropec, Jon
Chiu, Christopher
Trivedi, Sonali
Amin, Himal
Krevvata, Maria
Ramaswami, Priya
Qin, Xiang
Qi, Mia
Sun, Steven
Qi, Ming
Kobos, Rachel
Bahlis, Nizar J.
Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR
title Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR
title_full Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR
title_fullStr Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR
title_full_unstemmed Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR
title_short Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR
title_sort evaluation of sustained minimal residual disease negativity with daratumumab-combination regimens in relapsed and/or refractory multiple myeloma: analysis of pollux and castor
topic ORIGINAL REPORTS
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078259/
https://www.ncbi.nlm.nih.gov/pubmed/33513030
http://dx.doi.org/10.1200/JCO.20.01814
work_keys_str_mv AT avetloiseauherve evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT sanmigueljesus evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT casneuftineke evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT iidashinsuke evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT lonialsagar evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT usmanisaadz evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT spencerandrew evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT moreauphilippe evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT plesnertorben evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT weiselkatja evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT ukropecjon evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT chiuchristopher evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT trivedisonali evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT aminhimal evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT krevvatamaria evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT ramaswamipriya evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT qinxiang evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT qimia evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT sunsteven evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT qiming evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT kobosrachel evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor
AT bahlisnizarj evaluationofsustainedminimalresidualdiseasenegativitywithdaratumumabcombinationregimensinrelapsedandorrefractorymultiplemyelomaanalysisofpolluxandcastor