Daratumumab, lenalidomide, and dexamethasone in East Asian patients with relapsed or refractory multiple myeloma: subgroup analyses of the phase 3 POLLUX study

被引:24
作者
Suzuki, Kenshi [1 ]
Dimopoulos, Meletios A. [2 ]
Takezako, Naoki [3 ]
Okamoto, Shinichiro [4 ]
Shinagawa, Atsushi [5 ]
Matsumoto, Morio [6 ]
Kosugi, Hiroshi [7 ]
Yoon, Sung-Soo [8 ]
Huang, Shang-Yi [9 ]
Qin, Xiang [10 ]
Qi, Ming [10 ]
Iida, Shinsuke [11 ]
机构
[1] Japanese Red Cross Med Ctr, Dept Hematol, Tokyo, Japan
[2] Univ Athens, Athens, Greece
[3] Natl Hosp Org Disaster Med Ctr Japan, Dept Hematol, Tachikawa, Tokyo, Japan
[4] Keio Univ Hosp, Tokyo, Japan
[5] Hitachi Gen Hosp, Hitachi, Ibaraki, Japan
[6] Natl Hosp Org Shibukawa Med Ctr, Dept Hematol, Shibukawa, Japan
[7] Ogaki Municipal Hosp, Dept Hematol, Ogaki, Japan
[8] Seoul Natl Univ Hosp, Seoul, South Korea
[9] Natl Taiwan Univ Hosp, Taipei, Taiwan
[10] Janssen Res & Dev LLC, Spring House, PA USA
[11] Nagoya City Univ, Grad Sch Med Sci, Nagoya, Aichi, Japan
关键词
ANTIBODY DARATUMUMAB; JAPANESE PATIENTS; TARGETING CD38; MONOTHERAPY; CRITERIA; CANCER;
D O I
10.1038/s41408-018-0071-x
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
In the phase 3 POLLUX study, daratumumab plus lenalidomide and dexamethasone (DRd) significantly reduced the risk of progression/death and induced deeper responses vs. lenalidomide and dexamethasone alone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM). We report a subgroup analysis of East Asian (Japanese, Korean, and Taiwanese) patients from POLLUX based on a longer follow-up of 24.7 months. Median progression-free survival was not reached (NR) for DRd vs. 13.8 months for Rd (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.23-0.76), and overall response rates were higher for DRd vs. Rd (90.2 vs. 72.1%). DRd extended the median duration of response vs. Rd (NR vs. 20.2 months), and minimal residual disease-negative rates at the 10-5 sensitivity threshold were 21.2 vs. 9.1% for DRd vs. Rd. No new safety signals were observed. Similar efficacy and safety were observed in the smaller subgroup of Japanese patients treated with DRd vs. Rd. These results demonstrate favorable efficacy and safety of DRd vs. Rd in East Asian patients and also in the Japanese-only patient subgroup that are consistent with findings in the overall patient population of POLLUX.
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页数:9
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