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TIME TO RESPONSE, DURATION OF RESPONSE, AND PATIENT-REPORTED OUTCOMES WITH DARATUMUMAB PLUS RD VS RD ALONE IN TRANSPLANT-INELIGIBLE PATIENTS WITH NDMM: SUBGROUP ANALYSIS OF THE PHASE 3 MAIA STUDY
Author(s): ,
Thierry Facon
Affiliations:
University of Lille, CHU Lille, Service des Maladies du Sang,Lille,France;University of Lille, CHU Lille, Service des Maladies du Sang,Lille,Frankreich;University of Lille, CHU Lille, Service des Maladies du Sang,Lille,Francia;University of Lille, CHU Lille, Service des Maladies du Sang,Lille,France;University of Lille, CHU Lille, Service des Maladies du Sang,Lille,Francia;University of Lille, CHU
,
Shaji K Kumar
Affiliations:
Department of Hematology,Mayo Clinic Rochester,Rochester, MN,États-unis;Department of Hematology,Mayo Clinic Rochester,Rochester, MN,Vereinigte Staaten;Department of Hematology,Mayo Clinic Rochester,Rochester, MN,Stati Uniti;Department of Hematology,Mayo Clinic Rochester,Rochester, MN,United States;Department of Hematology,Mayo Clinic Rochester,Rochester, MN,Estados Unidos;Department of Hematology
,
Torben Plesner
Affiliations:
Vejle Hospital and University of Southern Denmark,Vejle,Danemark;Vejle Hospital and University of Southern Denmark,Vejle,Dänemark;Vejle Hospital and University of Southern Denmark,Vejle,Danimarca;Vejle Hospital and University of Southern Denmark,Vejle,Danemark;Vejle Hospital and University of Southern Denmark,Vejle,Dinamarca;Vejle Hospital and University of Southern Denmark,Vejle,Denemarken;Vejle
,
Philippe Moreau
Affiliations:
Hematology Department,University Hospital Hôtel-Dieu,Nantes,France;Hematology Department,University Hospital Hôtel-Dieu,Nantes,Frankreich;Hematology Department,University Hospital Hôtel-Dieu,Nantes,Francia;Hematology Department,University Hospital Hôtel-Dieu,Nantes,France;Hematology Department,University Hospital Hôtel-Dieu,Nantes,Francia;Hematology Department,University Hospital Hôtel-Dieu,Nantes
,
Nizar Bahlis
Affiliations:
Arnie Charbonneau Cancer Research Institute, University of Calgary,Calgary, AB,Canada;Arnie Charbonneau Cancer Research Institute, University of Calgary,Calgary, AB,Kanada;Arnie Charbonneau Cancer Research Institute, University of Calgary,Calgary, AB,Canada;Arnie Charbonneau Cancer Research Institute, University of Calgary,Calgary, AB,Canada;Arnie Charbonneau Cancer Research Institute, University
,
Hartmut Goldschmidt
Affiliations:
University Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT),Heidelberg,Allemagne;University Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT),Heidelberg,Deutschland;University Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT),Heidelberg,Germania;University Hospital Heidelberg, Internal Medi
,
Michael O'Dwyer
Affiliations:
Department of Medicine/Haematology,NUI,Galway,Irlande;Department of Medicine/Haematology,NUI,Galway,Irland;Department of Medicine/Haematology,NUI,Galway,Irlanda;Department of Medicine/Haematology,NUI,Galway,Ireland;Department of Medicine/Haematology,NUI,Galway,Irlanda;Department of Medicine/Haematology,NUI,Galway,Ierland;Department of Medicine/Haematology,NUI,Galway,Irlanda;Department of Medicine/
,
Aurore Perrot
Affiliations:
CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie,Toulouse,France;CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie,Toulouse,Frankreich;CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie,Toulouse,Francia;CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie,Toulouse,France;CHU de Toulouse, IUCT-O, Un
,
Christopher P Venner
Affiliations:
Cross Cancer Institute, University of Alberta,Edmonton, AB,Canada;Cross Cancer Institute, University of Alberta,Edmonton, AB,Kanada;Cross Cancer Institute, University of Alberta,Edmonton, AB,Canada;Cross Cancer Institute, University of Alberta,Edmonton, AB,Canada;Cross Cancer Institute, University of Alberta,Edmonton, AB,Canadá;Cross Cancer Institute, University of Alberta,Edmonton, AB,Canada;Cros
,
Katja Weisel
Affiliations:
Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology,University Medical Center Hamburg-Eppendorf,Hamburg,Allemagne;Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology,University Medical Center Hamburg-Eppendorf,Hamburg,Deutschland;Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pne
,
Joseph R Mace
Affiliations:
Florida Cancer Specialists,St. Petersburg, FL,États-unis;Florida Cancer Specialists,St. Petersburg, FL,Vereinigte Staaten;Florida Cancer Specialists,St. Petersburg, FL,Stati Uniti;Florida Cancer Specialists,St. Petersburg, FL,United States;Florida Cancer Specialists,St. Petersburg, FL,Estados Unidos;Florida Cancer Specialists,St. Petersburg, FL,Verenigde Staten;Florida Cancer Specialists,St. Peter
,
Noopur Raje
Affiliations:
Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center,Boston, MA,États-unis;Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center,Boston, MA,Vereinigte Staaten;Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center,Boston, MA,Stati Uniti;Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center,Boston, MA,United States;Cent
,
Mourad Tiab
Affiliations:
CHD Vendée,La Roche sur Yon,France;CHD Vendée,La Roche sur Yon,Frankreich;CHD Vendée,La Roche sur Yon,Francia;CHD Vendée,La Roche sur Yon,France;CHD Vendée,La Roche sur Yon,Francia;CHD Vendée,La Roche sur Yon,Frankrijk;CHD Vendée,La Roche sur Yon,França;CHD Vendée,La Roche sur Yon,Франция ;CHD Vendée,La Roche sur Yon,Frankrike
,
Margaret Macro
Affiliations:
Centre Hospitalier Universitaire (CHU) de Caen,Caen,France;Centre Hospitalier Universitaire (CHU) de Caen,Caen,Frankreich;Centre Hospitalier Universitaire (CHU) de Caen,Caen,Francia;Centre Hospitalier Universitaire (CHU) de Caen,Caen,France;Centre Hospitalier Universitaire (CHU) de Caen,Caen,Francia;Centre Hospitalier Universitaire (CHU) de Caen,Caen,Frankrijk;Centre Hospitalier Universitaire (CHU
,
Laurent Frenzel
Affiliations:
Department of Clinical Haematology,Hopital Necker-Enfants Malades,Paris,France;Department of Clinical Haematology,Hopital Necker-Enfants Malades,Paris,Frankreich;Department of Clinical Haematology,Hopital Necker-Enfants Malades,Paris,Francia;Department of Clinical Haematology,Hopital Necker-Enfants Malades,Paris,France;Department of Clinical Haematology,Hopital Necker-Enfants Malades,Paris,Francia
,
Xavier Leleu
Affiliations:
CHU Poitiers, Hôpital la Milétrie,Poitiers,France;CHU Poitiers, Hôpital la Milétrie,Poitiers,Frankreich;CHU Poitiers, Hôpital la Milétrie,Poitiers,Francia;CHU Poitiers, Hôpital la Milétrie,Poitiers,France;CHU Poitiers, Hôpital la Milétrie,Poitiers,Francia;CHU Poitiers, Hôpital la Milétrie,Poitiers,Frankrijk;CHU Poitiers, Hôpital la Milétrie,Poitiers,França;CHU Poitiers, Hôpital la Milétrie,Poitier
,
Huiling Pei
Affiliations:
Janssen Research & Development, LLC,Titusville, NJ,États-unis;Janssen Research & Development, LLC,Titusville, NJ,Vereinigte Staaten;Janssen Research & Development, LLC,Titusville, NJ,Stati Uniti;Janssen Research & Development, LLC,Titusville, NJ,United States;Janssen Research & Development, LLC,Titusville, NJ,Estados Unidos;Janssen Research & Develop
,
Fredrik Borgsten
Affiliations:
Janssen-Cilag,Birkerød,Danemark;Janssen-Cilag,Birkerød,Dänemark;Janssen-Cilag,Birkerød,Danimarca;Janssen-Cilag,Birkerød,Danemark;Janssen-Cilag,Birkerød,Dinamarca;Janssen-Cilag,Birkerød,Denemarken;Janssen-Cilag,Birkerød,Dinamarca;Janssen-Cilag,Birkerød,Дания;Janssen-Cilag,Birkerød,Danmark
Saad Z Usmani
Affiliations:
Memorial Sloan Kettering Cancer Center,New York, NY,États-unis;Memorial Sloan Kettering Cancer Center,New York, NY,Vereinigte Staaten;Memorial Sloan Kettering Cancer Center,New York, NY,Stati Uniti;Memorial Sloan Kettering Cancer Center,New York, NY,United States;Memorial Sloan Kettering Cancer Center,New York, NY,Estados Unidos;Memorial Sloan Kettering Cancer Center,New York, NY,Verenigde Staten;
(Abstract release date: 05/26/22) EHA Library. Facon T. 06/10/22; 357795; P936
Prof. Thierry Facon
Prof. Thierry Facon
Contributions
Abstract
Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P936

Type: Poster presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background
In the phase 3 MAIA study, adding daratumumab (DARA) to lenalidomide and dexamethasone (Rd) improved progression-free survival (primary endpoint), overall survival, duration of response, and patient-reported outcomes (PROs) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM).

Aims
Here we report a MAIA subgroup analysis of time to response, duration of response, and PROs. 

Methods
Transplant-ineligible patients with NDMM received 28-day cycles of Rd (R 25 mg PO on Days 1-21; d 40 mg PO QW) ± DARA (16 mg/kg IV QW in Cycles 1-2, Q2W in Cycles 3-6, and Q4W thereafter) until disease progression or unacceptable toxicity. Secondary endpoints included time to response and duration of response. PROs were measured using the EORTC QLQ-C30, with treatment effects assessed via mixed-effects model with repeated measures.

Results
In total, 368 patients were assigned to the DARA plus lenalidomide and dexamethasone (D-Rd) group and 369 patients to the Rd group; 162 (44%) D-Rd patients and 142 (38%) Rd patients had renal impairment (defined as baseline CrCl ≤60 mL/min). At a 56.2-mo median follow-up, median times to very good partial response or better (≥VGPR) and complete response or better (≥CR) were shorter with D-Rd vs Rd in the overall study population and in the subgroups of patients with and without renal impairment (Table). Among patients who achieved ≥CR or partial response or better (≥PR), higher proportions of D-Rd vs Rd patients had not experienced disease progression at 48 mo (Table). Among patients with renal impairment, greater improvements from baseline in patient-reported pain, fatigue, and nausea and vomiting symptom scores were observed with D-Rd vs Rd across most timepoints; a notably greater meaningful reduction in pain symptom score was seen with D-Rd vs Rd as early as Cycle 6 Day 1 (least squares mean change from baseline, −14.9 vs −7.0; P=0.0241). Analyses for additional patient subgroups will be presented. 

Conclusion
In transplant-ineligible patients with NDMM, D-Rd showed more rapid deep responses as well as more durable responses vs Rd, regardless of renal function. Improvements in patient-reported symptoms were generally greater with D-Rd vs Rd in patients with renal impairment. Our results support the use of D-Rd in transplant-ineligible patients with NDMM.

Keyword(s): CD38, Immune therapy, Multiple myeloma



© 2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting. All rights reserved.
Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P936

Type: Poster presentation

Session title: Myeloma and other monoclonal gammopathies - Clinical

Background
In the phase 3 MAIA study, adding daratumumab (DARA) to lenalidomide and dexamethasone (Rd) improved progression-free survival (primary endpoint), overall survival, duration of response, and patient-reported outcomes (PROs) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM).

Aims
Here we report a MAIA subgroup analysis of time to response, duration of response, and PROs. 

Methods
Transplant-ineligible patients with NDMM received 28-day cycles of Rd (R 25 mg PO on Days 1-21; d 40 mg PO QW) ± DARA (16 mg/kg IV QW in Cycles 1-2, Q2W in Cycles 3-6, and Q4W thereafter) until disease progression or unacceptable toxicity. Secondary endpoints included time to response and duration of response. PROs were measured using the EORTC QLQ-C30, with treatment effects assessed via mixed-effects model with repeated measures.

Results
In total, 368 patients were assigned to the DARA plus lenalidomide and dexamethasone (D-Rd) group and 369 patients to the Rd group; 162 (44%) D-Rd patients and 142 (38%) Rd patients had renal impairment (defined as baseline CrCl ≤60 mL/min). At a 56.2-mo median follow-up, median times to very good partial response or better (≥VGPR) and complete response or better (≥CR) were shorter with D-Rd vs Rd in the overall study population and in the subgroups of patients with and without renal impairment (Table). Among patients who achieved ≥CR or partial response or better (≥PR), higher proportions of D-Rd vs Rd patients had not experienced disease progression at 48 mo (Table). Among patients with renal impairment, greater improvements from baseline in patient-reported pain, fatigue, and nausea and vomiting symptom scores were observed with D-Rd vs Rd across most timepoints; a notably greater meaningful reduction in pain symptom score was seen with D-Rd vs Rd as early as Cycle 6 Day 1 (least squares mean change from baseline, −14.9 vs −7.0; P=0.0241). Analyses for additional patient subgroups will be presented. 

Conclusion
In transplant-ineligible patients with NDMM, D-Rd showed more rapid deep responses as well as more durable responses vs Rd, regardless of renal function. Improvements in patient-reported symptoms were generally greater with D-Rd vs Rd in patients with renal impairment. Our results support the use of D-Rd in transplant-ineligible patients with NDMM.

Keyword(s): CD38, Immune therapy, Multiple myeloma



© 2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting. All rights reserved.

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