TY - JOUR
T1 - Daratumumab for newly diagnosed multiple myeloma
T2 - Pooled analysis of patients aged ≥65 years from GRIFFIN and PERSEUS
AU - Rodriguez-Otero, Paula
AU - Voorhees, Peter M.
AU - Boccadoro, Mario
AU - Laubach, Jacob
AU - Einsele, Hermann
AU - Sborov, Douglas W.
AU - Dimopoulos, Meletios A.
AU - Broijl, Annemiek
AU - Mina, Roberto
AU - Spencer, Andrew
AU - Schjesvold, Fredrik
AU - Silbermann, Rebecca
AU - Gay, Francesca
AU - Costa, Luciano J.
AU - Perrot, Aurore
AU - Liu, Yanfang
AU - Wang, Jianping
AU - Sitthi-Amorn, Anna
AU - Carson, Robin
AU - Cortoos, Annelore
AU - Usmani, Saad Z.
AU - Richardson, Paul G.
AU - Moreau, Philippe
AU - Sonneveld, Pieter
AU - Kaufman, Jonathan L.
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/10
Y1 - 2025/10
N2 - Background: Older adults with newly diagnosed multiple myeloma (NDMM) have poor prognosis and constitute a subgroup of particular interest. In the GRIFFIN (NCT02874742) and PERSEUS (NCT03710603) studies, adding daratumumab to bortezomib/lenalidomide/dexamethasone (VRd) induction/consolidation and lenalidomide (R) maintenance deepened responses and improved progression-free survival (PFS) versus VRd/R in transplant-eligible patients with NDMM. Subgroup analyses of patients aged ≥65 years in PERSEUS demonstrated less pronounced PFS benefits (HRs: 0.97 [computerized algorithm]; 0.87 [independent review committee (IRC)]), potentially due to small event numbers, cytogenetic risk imbalances (high risk: D-VRd, 25.5%; VRd, 19.5%), and specific censoring rules. Here, we report results from a post hoc, pooled analysis of GRIFFIN and PERSEUS in patients aged ≥65 years (D-VRd, n = 122; VRd, n = 115). Methods: Using patient-level data, PFS analysis was evaluated per computerized algorithm in GRIFFIN and IRC in PERSEUS, stratified by International Staging System stage and cytogenetic risk, with no censoring of PFS events after ≥2 missing disease evaluations.Results: At a median follow-up of 49.6/47.5 months (GRIFFIN/PERSEUS), a trend in improved PFS was seen among patients aged ≥65 years favoring D-VRd (HR, 0.56 [95% CI, 0.30-1.01]). D-VRd improved rates of complete response or better (82.8% vs. 67.0%; OR, 2.37 [95% CI, 1.28-4.39]; P = .0046) and minimal residual disease negativity (10–5; 66.4% vs. 41.7%; OR, 2.75 [95% CI, 1.61-4.71]; P = .0002) versus VRd. No new safety concerns were identified. Conclusion: These data support use of D-VRd followed by D-R maintenance as standard of care for all transplant-eligible patients with NDMM, regardless of age up to 70 years.
AB - Background: Older adults with newly diagnosed multiple myeloma (NDMM) have poor prognosis and constitute a subgroup of particular interest. In the GRIFFIN (NCT02874742) and PERSEUS (NCT03710603) studies, adding daratumumab to bortezomib/lenalidomide/dexamethasone (VRd) induction/consolidation and lenalidomide (R) maintenance deepened responses and improved progression-free survival (PFS) versus VRd/R in transplant-eligible patients with NDMM. Subgroup analyses of patients aged ≥65 years in PERSEUS demonstrated less pronounced PFS benefits (HRs: 0.97 [computerized algorithm]; 0.87 [independent review committee (IRC)]), potentially due to small event numbers, cytogenetic risk imbalances (high risk: D-VRd, 25.5%; VRd, 19.5%), and specific censoring rules. Here, we report results from a post hoc, pooled analysis of GRIFFIN and PERSEUS in patients aged ≥65 years (D-VRd, n = 122; VRd, n = 115). Methods: Using patient-level data, PFS analysis was evaluated per computerized algorithm in GRIFFIN and IRC in PERSEUS, stratified by International Staging System stage and cytogenetic risk, with no censoring of PFS events after ≥2 missing disease evaluations.Results: At a median follow-up of 49.6/47.5 months (GRIFFIN/PERSEUS), a trend in improved PFS was seen among patients aged ≥65 years favoring D-VRd (HR, 0.56 [95% CI, 0.30-1.01]). D-VRd improved rates of complete response or better (82.8% vs. 67.0%; OR, 2.37 [95% CI, 1.28-4.39]; P = .0046) and minimal residual disease negativity (10–5; 66.4% vs. 41.7%; OR, 2.75 [95% CI, 1.61-4.71]; P = .0002) versus VRd. No new safety concerns were identified. Conclusion: These data support use of D-VRd followed by D-R maintenance as standard of care for all transplant-eligible patients with NDMM, regardless of age up to 70 years.
UR - https://www.scopus.com/pages/publications/105004888257
U2 - 10.1016/j.clml.2025.04.007
DO - 10.1016/j.clml.2025.04.007
M3 - Article
C2 - 40360369
AN - SCOPUS:105004888257
SN - 2152-2650
VL - 25
SP - 746-758.e6
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 10
ER -
