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Author Notes:

Correspondence: mdimop@med.uoa.gr

Medical writing and editorial support were provided by Jason Jung, PhD, and Sima Patel, PhD, of MedErgy, and were funded by Janssen Global Services, LLC.

The authors wish to thank the patients participating in this study and their families, as well as the global network of investigators, research nurses, study coordinators, and operations staff (including Sonali Trivedi, Jaime Bald, Xiang Qin, and Christopher Velas).

JLK consulted for BMS, Janssen, Celgene, Karyopharm, and Pharmacyclics.

Subjects:

Research Funding:

This study was sponsored by Janssen Research & Development, LLC.

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Hematology
  • ANTIBODY DARATUMUMAB
  • CRITERIA

Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX

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Journal Title:

Haematologica

Volume:

Volume 103, Number 12

Publisher:

, Pages 2088-2096

Type of Work:

Article | Final Publisher PDF

Abstract:

In the POLLUX study, daratumumab plus lenalidomide/dexamethasone significantly reduced risk of progression/death versus lenalidomide/ dexamethasone alone in relapsed/refractory multiple myeloma. We provide one additional year of follow up and include the effect on minimal residual disease and in clinically relevant subgroups. After 25.4 months of follow up, daratumumab plus lenalidomide/dexamethasone prolonged progression-free survival versus lenalidomide/dexamethasone alone (median not reached vs. 17.5 months; hazard ratio, 0.41; 95% confidence interval, 0.31-0.53; P<0.0001). The overall response rate was 92.9% versus 76.4%, and 51.2% versus 21.0% achieved a complete response or better, respectively (both P<0.0001). At the 10–5 sensitivity threshold, 26.2% versus 6.4% were minimal residual disease–negative, respectively (P<0.0001). Post hoc analyses of clinically relevant patient subgroups demonstrated that progression-free survival was significantly prolonged for daratumumab plus lenalidomide/dexamethasone versus lenalidomide/dexamethasone regardless of number of prior lines of therapy. Patients previously treated with lenalidomide or thalidomide and those refractory to bortezomib received similar benefits (all P<0.01). Treatment benefit with daratumumab plus lenalidomide/dexamethasone was maintained in high-risk patients (median progression-free survival 22.6 vs. 10.2 months; hazard ratio, 0.53; 95% confidence interval, 0.25-1.13; P=0.0921) and patients with treatment-free intervals of >12 and ≤12 months and >6 and ≤6 months. No new safety signals were observed. In relapsed/refractory multiple myeloma patients, daratumumab plus lenalidomide/dexamethasone continued to improve progression-free survival and deepen responses versus lenalidomide/dexamethasone.

Copyright information:

© 2018 Ferrata Storti Foundation.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/).

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