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Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial

  • Tomoaki Fujisaki
  • , Takayuki Ishikawa
  • , Hiroyuki Takamatsu
  • , Kenshi Suzuki
  • , Chang Ki Min
  • , Jae Hoon Lee
  • , Jianping Wang
  • , Robin Carson
  • , Wendy Crist
  • , Ming Qi
  • , Koji Nagafuji
  • Japanese Red Cross Matsuyama Hospital
  • Kobe City Medical Center General Hospital
  • Kanazawa University
  • Japanese Red Cross Medical Center
  • Gachon University
  • Johnson & Johnson
  • Kurume University

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

In the ALCYONE trial, daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) reduced the risk of disease progression or death by 50% versus bortezomib, melphalan, and prednisone (VMP) in patients with transplant-ineligible newly diagnosed multiple myeloma. Here, we report a subanalysis of East Asian patients from ALCYONE. After a median follow-up of 17.1 and 15.9 months for Japanese (n = 50) and Korean (n = 41) patients, respectively, median progression-free survival for D-VMP versus VMP was not reached (NR) versus 20.7 months in Japanese patients and NR versus 14.0 months in Korean patients. The overall response rate for D-VMP versus VMP was 96% versus 92% in Japanese patients and 91% versus 61% in Korean patients. Using next-generation sequencing, minimal residual disease negativity at 10−5 sensitivity for D-VMP versus VMP was 33% versus 8% among Japanese patients and 17% versus 0% among Korean patients. Rates of any grade and grade 3/4 pneumonia were consistent with the rates observed for the global safety population. Similar efficacy and safety findings were observed in the combined Japanese and Korean subgroup and ≥ 75 years of age subgroup. In conclusion, D-VMP was safe and efficacious in East Asian patients, consistent with the global ALCYONE population.

Original languageEnglish
Pages (from-to)2805-2814
Number of pages10
JournalAnnals of Hematology
Volume98
Issue number12
DOIs
StatePublished - 1 Dec 2019

Bibliographical note

Publisher Copyright:
© 2019, The Author(s).

Keywords

  • Daratumumab
  • Multiple myeloma
  • Transplant-ineligible
  • VMP

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