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Three-Year Follow up of the Phase 3 Pollux Study of Daratumumab Plus

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Three-Year Follow up of the Phase 3 Pollux Study of Daratumumab Plus This is a repository copy of Three-Year Follow up of the Phase 3 Pollux Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Relapsed or Refractory Multiple Myeloma (RRMM). White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/157106/ Version: Accepted Version Proceedings Paper: Bahlis, N, Dimopoulos, MA, White, DJ et al. (14 more authors) (2018) Three-Year Follow up of the Phase 3 Pollux Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Relapsed or Refractory Multiple Myeloma (RRMM). In: Blood. ASH 2018 – 60th American Society of Hematology Annual Meeting and Exposition, 01-04 Dec 2018, San Diego, CA. American Society of Hematology . https://doi.org/10.1182/blood-2018-99-112697 © 2018 by The American Society of Hematology. This is an author produced version of a conference abstract published in Blood. Uploaded in accordance with the publisher's self-archiving policy. Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX Authors: Nizar J. Bahlis,1 Meletios A. Dimopoulos,2 Darrell J. White,3 Lotfi Benboubker,4 Gordon Cook,5 Merav Leiba,6 P. Joy Ho,7 Kihyun Kim,8 Naoki Takezako,9 Philippe Moreau,10 Jonathan L Kaufman,11 Maria Krevvata,12 Christopher Chiu,12 Xiang Qin,12 Linda Okonkwo,13 Sonali Trivedi,12 Jon Ukropec,14 Ming Qi,12 and Jesus San-Miguel15 Author affiliations: 1University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada; 2The National and Kapodistrian University of Athens, Athens, Greece; 3QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada; 4Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France; 5St James’s Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, United Kingdom; 6Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel; 7Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; 8Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; 9Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan; 10Hematology, University Hospital Hôtel-Dieu, Nantes, France; 11Winship Cancer Institute, Emory University, Atlanta, GA, United States of America; 12Janssen Research & Development, LLC, Spring House, PA, United States of America; 13Janssen Research & Development, LLC, Raritan, NJ, United States of America; 14Janssen Global Medical Affairs, Horsham, PA, United States of America; and 15Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain Corresponding Author: Nizar J. Bahlis, University of Calgary, Charbonneau Cancer Research Institute, Divisions of Hematology and Oncology, 1403 - 29th St NW Rm C210, Calgary, AB T2N 2T9. Telephone: 403-944-5246. E-mail: [email protected] Conflict of Interest NJB consulted for and received honoraria and research funding from Janssen, Celgene, and Amgen. MAD consulted for and received honoraria from Janssen, Celgene, Takeda, Amgen, and Bristol-Myers Squibb. DJW received honoraria from and served on advisory committees for Amgen, Celgene, Janssen, and Takeda. GC received honoraria from Amgen, Bristol-Myers Squibb, GlycoMimetics, Celgene, Janssen, Takeda, and Sanofi; and received research funding 1 from Celgene, Janssen, and Takeda. PJH received honoraria from Janssen, Amgen, Novartis, and Takeda; and received travel support from Takeda and Celgene. PM received honoraria from and served on advisory committees for Amgen, Celgene, Janssen, Takeda, and AbbVie. JLK served in a consulting or advisory role for Janssen, Celgene, Takeda, Amgen, and Sanofi Genzyme; and received research funding from Janssen, Bluebird, Bristol-Myers Squibb, Celgene, and Sutro Biopharma. MK, CC, XQ, LO, ST, JU, and MQ are employees of Janssen. JS-M received honoraria from Janssen, Celgene, Amgen, Bristol-Myers Squibb, Novartis, Sanofi, and Roche. LB, ML, KK, and NT have no conflicts of interest to disclose. Running Title: POLLUX: Extended Follow-up of Daratumumab Plus Lenalidomide and Dexamethasone Manuscript word count (max 4,000 words): 2,792 words Number of figures/tables (max 8 figures/tables): 4 figures and 2 tables Number of references (max 60 references): 28 references 2 Abstract In POLLUX, daratumumab (D) plus lenalidomide and dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P<0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9% vs 76.4%; P<0.0001) and deeper responses including complete response or better (56.6% vs 23.2%; P<0.0001) and MRD negativity (10–5; 30.4% vs 5.3%; P<0.0001). Median time to next therapy was prolonged with D- Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P<0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P<0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse. 3 Introduction The development of first- and second-generation novel agents over the past decade has led to the acceptance of immunomodulatory drug (IMiD)–based or proteasome inhibitor (PI)–based doublet or triplet therapy as standard of care for newly diagnosed and relapsed or refractory multiple myeloma (RRMM).1, 2 However, multiple myeloma (MM) remains an incurable disease, underscoring the need for new treatment strategies. Optimal combination and sequencing of these next-generation agents remain to be defined, particularly among various patient subgroups. Daratumumab is a human immunoglobulin G (IgG) monoclonal antibody targeting CD38 with a direct on-tumor3-6 and immunomodulatory mechanism of action.7-9 Daratumumab-induced on- tumor activity occurs through several CD38 immune-mediated actions (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis), apoptosis, and modulation of CD38 enzymatic activity.3-6 The immunomodulatory actions of daratumumab minimize the immune-suppressive functions of CD38+ myeloid-derived tumor suppressor cells, regulatory T cells, and regulatory B cells and increase T-cell clonality.7-9 Daratumumab has demonstrated single-agent activity in heavily pretreated RRMM and in combination with standard-of-care regimens in RRMM after at least 1 prior therapy.10-13 Daratumumab safety and efficacy are also established in combination with bortezomib, melphalan, and prednisone, and with lenalidomide and dexamethasone in patients with newly diagnosed MM (NDMM) who are transplantation ineligible.14, 15 4 In the prespecified interim analysis of the phase 3 POLLUX study (median follow-up, 13.5 months), daratumumab in combination with lenalidomide and dexamethasone (D-Rd) reduced the risk of disease progression or death by 63% (median progression-free survival [PFS] not reached vs 18.4 months; hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.27-0.52; P <0.001) and significantly increased the overall response rate (ORR) compared with lenalidomide and dexamethasone (Rd) alone (93% vs 76%; P <0.001) in patients with at least 1 prior therapy.12 In an updated analysis after a longer follow-up of 25.4 months, the PFS benefit of D- Rd was maintained compared with Rd, with median PFS still not being reached for D-Rd versus 17.5 months for Rd. In addition, deep and durable responses were achieved with D-Rd, and the PFS benefit of D-Rd versus Rd was consistently maintained regardless of the number of prior lines of therapy received, prior IMiD exposure, bortezomib refractoriness, time since last therapy, or cytogenetic risk.16 We report the long-term efficacy and safety analyses of POLLUX after a median follow-up of more than 3.5 years. Subjects and Methods Study design and patients POLLUX is an ongoing, randomized, open-label, multicenter,
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