Τίτλος:
Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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).
Συγγραφείς:
Bahlis, N.J.
Dimopoulos, M.A.
White, D.J.
Benboubker, L.
Cook, G.
Leiba, M.
Ho, P.J.
Kim, K.
Takezako, N.
Moreau, P.
Kaufman, J.L.
Krevvata, M.
Chiu, C.
Qin, X.
Okonkwo, L.
Trivedi, S.
Ukropec, J.
Qi, M.
San-Miguel, J.
Περιοδικό:
Leukemia Research
Εκδότης:
Springer Nature BV
Λέξεις-κλειδιά:
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
DOI:
10.1038/s41375-020-0711-6
