TY - JOUR
T1 - Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma
T2 - extended follow-up of POLLUX, a randomized, open-label, phase 3 study
AU - Bahlis, Nizar J.
AU - Dimopoulos, Meletios A.
AU - White, Darrell J.
AU - Benboubker, Lotfi
AU - Cook, Gordon
AU - Leiba, Merav
AU - Ho, P. Joy
AU - Kim, Kihyun
AU - Takezako, Naoki
AU - Moreau, Philippe
AU - Kaufman, Jonathan L.
AU - Krevvata, Maria
AU - Chiu, Christopher
AU - Qin, Xiang
AU - Okonkwo, Linda
AU - Trivedi, Sonali
AU - Ukropec, Jon
AU - Qi, Ming
AU - San-Miguel, Jesus
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85078714617&partnerID=8YFLogxK
U2 - 10.1038/s41375-020-0711-6
DO - 10.1038/s41375-020-0711-6
M3 - Article
C2 - 32001798
AN - SCOPUS:85078714617
SN - 0887-6924
VL - 34
SP - 1875
EP - 1884
JO - Leukemia
JF - Leukemia
IS - 7
ER -
