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

Author:

Avet-Loiseau Hervé1ORCID,San-Miguel Jesus2ORCID,Casneuf Tineke3,Iida Shinsuke4ORCID,Lonial Sagar5ORCID,Usmani Saad Z.6ORCID,Spencer Andrew7,Moreau Philippe8,Plesner Torben9,Weisel Katja10,Ukropec Jon11,Chiu Christopher12,Trivedi Sonali12,Amin Himal13,Krevvata Maria12,Ramaswami Priya14,Qin Xiang12,Qi Mia13,Sun Steven13,Qi Ming12,Kobos Rachel13,Bahlis Nizar J.15ORCID

Affiliation:

1. Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France

2. Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain

3. Janssen Research & Development, Beerse, Belgium

4. Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan

5. Winship Cancer Institute, Emory University, Atlanta, GA

6. Levine Cancer Institute/Atrium Health, Charlotte, NC

7. Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia

8. Hematology, University Hospital Hôtel-Dieu, Nantes, France

9. Vejle Hospital and University of Southern Denmark, Vejle, Denmark

10. University Medical Center of Hamburg-Eppendorf, Hamburg, Germany

11. Janssen Scientific Affairs, LLC, Horsham, PA

12. Janssen Research & Development, LLC, Spring House, PA

13. Janssen Research & Development, LLC, Raritan, NJ

14. Janssen Research & Development, LLC, Titusville, NJ

15. University of Calgary, Arnie Charbonneau Cancer Institute, Calgary, AB, Canada

Abstract

PURPOSE 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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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1. Biomarker-directed therapy in multiple myeloma;Current Opinion in Oncology;2024-08-23

2. A roadmap towards improving outcomes in multiple myeloma;Blood Cancer Journal;2024-08-12

3. Prognosis of concurrent renal impairment at diagnosis of multiple myeloma: a systematic review;Annals of Medicine;2024-07-22

4. Multiple myeloma;Nature Reviews Disease Primers;2024-06-27

5. Measurable Residual Disease and Decision-Making in Multiple Myeloma;Hematology/Oncology Clinics of North America;2024-04

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