Daratumumab, lenalidomide, and dexamethasone in East Asian patients with relapsed or refractory multiple myeloma: Subgroup analyses of the phase 3 POLLUX study
Journal
Blood Cancer Journal
Journal Volume
8
Journal Issue
4
Date Issued
2018
Author(s)
Suzuki K.
Dimopoulos M.A.
Takezako N.
Okamoto S.
Shinagawa A.
Matsumoto M.
Kosugi H.
Yoon S.-S.
Qin X.
Qi M.
Iida S.
Abstract
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. ? 2018 The Author(s).
SDGs
Other Subjects
daratumumab; dexamethasone; lenalidomide; antineoplastic agent; daratumumab; dexamethasone; lenalidomide; monoclonal antibody; adult; aged; anemia; Article; Bowen disease; cancer recurrence; cataract; comparative study; constipation; controlled study; coughing; decreased appetite; diarrhea; disease exacerbation; drug efficacy; drug safety; drug tolerability; drug withdrawal; dyspnea; fatigue; febrile neutropenia; female; fever; follow up; human; hyperglycemia; hypertransaminasemia; hypophosphatemia; infusion related reaction; insomnia; Japanese (people); kidney disease; Korean (people); leukocytosis; leukopenia; lymphocytopenia; lymphoproliferative disease; major clinical study; male; minimal residual disease; multiple cycle treatment; multiple myeloma; multiple organ failure; nausea; neutropenia; phase 3 clinical trial; pneumonia; progression free survival; randomized controlled trial; rhinopharyngitis; second cancer; somnolence; Taiwanese; thrombocytopenia; treatment outcome; treatment response; upper respiratory tract infection; clinical trial; drug resistance; middle aged; multiple myeloma; recurrent disease; retreatment; very elderly; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Female; Humans; Lenalidomide; Male; Middle Aged; Multiple Myeloma; Recurrence; Retreatment; Treatment Outcome
Publisher
Nature Publishing Group
Type
journal article