TY - JOUR
TI - Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study
AU - Bahlis, N.J.
AU - Dimopoulos, M.A.
AU - White, D.J.
AU - Benboubker, L.
AU - Cook, G.
AU - Leiba, M.
AU - Ho, P.J.
AU - Kim, K.
AU - Takezako, N.
AU - Moreau, P.
AU - Kaufman, J.L.
AU - Krevvata, M.
AU - Chiu, C.
AU - Qin, X.
AU - Okonkwo, L.
AU - Trivedi, S.
AU - Ukropec, J.
AU - Qi, M.
AU - San-Miguel, J.
JO - Leukemia Research
PY - 2020
VL - 34
TODO - 7
SP - 1875-1884
PB - Springer Nature BV
SN - 0145-2126
TODO - 10.1038/s41375-020-0711-6
TODO - daratumumab;  dexamethasone;  lenalidomide;  antineoplastic agent;  daratumumab;  dexamethasone;  lenalidomide;  monoclonal antibody;  thalidomide, adult;  aged;  anemia;  Article;  cataract;  controlled study;  diarrhea;  drug efficacy;  drug response;  drug safety;  fatigue;  febrile neutropenia;  female;  follow up;  high throughput sequencing;  human;  hypokalemia;  intention to treat analysis;  lung embolism;  lymphocytopenia;  major clinical study;  male;  minimal residual disease;  multiple cycle treatment;  multiple myeloma;  neutropenia;  phase 3 clinical trial;  pneumonia;  priority journal;  progression free survival;  randomized controlled trial;  septic shock;  thrombocytopenia;  treatment duration;  clinical trial;  drug effect;  drug resistance;  multicenter study;  multiple myeloma;  pathology;  prognosis;  salvage therapy;  survival rate;  tumor recurrence, Aged;  Antibodies, Monoclonal;  Antineoplastic Combined Chemotherapy Protocols;  Dexamethasone;  Drug Resistance, Neoplasm;  Female;  Follow-Up Studies;  Humans;  Lenalidomide;  Male;  Multiple Myeloma;  Neoplasm Recurrence, Local;  Prognosis;  Salvage Therapy;  Survival Rate;  Thalidomide
TODO - In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1–21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35–0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10–5; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31–0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42–0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse. © 2020, The Author(s).
ER -