Daratumumab plus lenalidomide and dexamethasone in relapsed/ refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study

Bahlis, N.J. (Nizar J.); Dimopoulos, M.A. (Meletios A.); White, D.J. (Darrell J.); Benboubker, L. (Lotfi); Cook, G. (Gordon); Leiba, M. (Merav); Ho, P.J. (P. Joy); Kim, K. (Kihyun); Takezako, N. (Naoki); Moreau, P. (Philippe); Kaufman, J.L. (Jonathan L.); Krevvata, M. (Maria); Chiu, C. (Christopher); Qin, X. (Xiang); Okonkwo, L. (Linda); Trivedi, S. (Sonali); Ukropec, J. (Jon); Qi, M. (Ming); San-Miguel, J.F. (Jesús F.)

Issue Date:

2020

ISSN:

0887-6924

Note:

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Citation:

Bahlis, N.J. (Nizar J.); Dimopoulos, M.A. (Meletios A.); White, D.J. (Darrell J.); et al. "Daratumumab plus lenalidomide and dexamethasone in relapsed/ refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study". Leukemia. 34, 2020, 1875 - 1884

Abstract

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.

URI:

https://hdl.handle.net/10171/65789

DOI:

10.1038/s41375-020-0711-6

Appears in Collections:

DA - CIMA - Hemato-oncología - Mieloma - Artículos de Revista

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