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Clinical Trial
. 2019 Dec;98(12):2805-2814.
doi: 10.1007/s00277-019-03794-9. Epub 2019 Oct 16.

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  1 , Takayuki Ishikawa  2 , Hiroyuki Takamatsu  3 , Kenshi Suzuki  4 , Chang-Ki Min  5 , Jae Hoon Lee  6 , Jianping Wang  7 , Robin Carson  8 , Wendy Crist  8 , Ming Qi  8 , Koji Nagafuji  9
Affiliations
Clinical Trial

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 et al. Ann Hematol. 2019 Dec.

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.

Keywords: Daratumumab; Multiple myeloma; Transplant-ineligible; VMP.

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Conflict of interest statement

Hiroyuki Takamatsu received honoraria from Janssen. Kenshi Suzuki received honoraria from Celgene, Takeda, and Janssen and consulted for Takeda. Jianping Wang, Robin Carson, Wendy Crist, and Ming Qi are employees of Janssen. Tomoaki Fujisaki, Takayuki Ishikawa, Chang-Ki Min, Jae Hoon Lee, and Koji Nagafuji have no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
PFS of a ITT population, b East Asian patients, c Japanese patients, and d Korean patients in ALCYONE. PFS progression-free survival, ITT intent-to-treat, D-VMP daratumumab/bortezomib/ melphalan/prednisone, VMP bortezomib/melphalan/prednisone, HR hazard ratio, CI confidence interval. aKaplan-Meier estimates. Figure 1a is adapted from the New England Journal of Medicine. Mateos MV, et al. “Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma”. 378(6):518–528. Copyright © (2018) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society
See this image and copyright information in PMC

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