Publicaciones científicas

Daratumumab, lenalidomide, and dexamethasone in relapsed/refractory myeloma: a cytogenetic subgroup analysis of POLLUX

03-nov-2020 | Revista: Blood Cancer Journal

Jonathan L Kaufman  1 , Meletios A Dimopoulos  2 , Darrell White  3 , Lotfi Benboubker  4 , Gordon Cook  5 , Merav Leiba  6 , James Morton  7 , P Joy Ho  8 , Kihyun Kim  9 , Naoki Takezako  10 , Philippe Moreau  11 , Heather J Sutherland  12 , Hila Magen  13 , Shinsuke Iida  14 , Jin Seok Kim  15 , H Miles Prince  16 , Tara Cochrane  17 , Albert Oriol  18 , Nizar J Bahlis  19 , Ajai Chari  20 , Lisa O'Rourke  21 , Sonali Trivedi  21 , Tineke Casneuf  22 , Maria Krevvata  21 , Jon Ukropec  23 , Rachel Kobos  24 , Hervé Avet-Loiseau  25 , Saad Z Usmani  26 , Jesus San-Miguel 27


Abstract

High cytogenetic risk abnormalities confer poor outcomes in multiple myeloma patients. In POLLUX, daratumumab/lenalidomide/dexamethasone (D-Rd) demonstrated significant clinical benefit versus lenalidomide/dexamethasone (Rd) in relapsed/refractory multiple myeloma (RRMM) patients.

We report an updated subgroup analysis of POLLUX based on cytogenetic risk. The cytogenetic risk was determined using fluorescence in situ hybridization/karyotyping; patients with high cytogenetic risk had t(4;14), t(14;16), or del17p abnormalities.

Minimal residual disease (MRD; 10-5) was assessed via the clonoSEQ® assay V2.0. 569 patients were randomized (D-Rd, n = 286; Rd, n = 283); 35 (12%) patients per group had high cytogenetic risk. After a median follow-up of 44.3 months, D-Rd prolonged progression-free survival (PFS) versus Rd in standard cytogenetic risk (median: not estimable vs 18.6 months; hazard ratio [HR], 0.43; P < 0.0001) and high cytogenetic risk (median: 26.8 vs 8.3 months; HR, 0.34; P = 0.0035) patients.

Responses with D-Rd were deep, including higher MRD negativity and sustained MRD-negativity rates versus Rd, regardless of cytogenetic risk. PFS on subsequent line of therapy was improved with D-Rd versus Rd in both cytogenetic risk subgroups. The safety profile of D-Rd by cytogenetic risk was consistent with the overall population.

These findings demonstrate the improved efficacy of daratumumab plus standard of care versus standard of care in RRMM, regardless of cytogenetic risk.

CITA DEL ARTÍCULO  Blood Cancer J. 2020 Nov 3;10(11):111.  doi: 10.1038/s41408-020-00375-2

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