Publicaciones científicas
Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis
Paul G Richardson 1 , Aurore Perrot 2 , Jesus San Miguel 3 , Meral Beksac 4 , Ivan Spicka 5 , Xavier Leleu 6 , Fredrik Schjesvold 7 , Philippe Moreau 8 , Meletios A Dimopoulos 9 , Shang-Yi Huang 10 , Jiri Minarik 11 , Michele Cavo 12 , H Miles Prince 13 , Sandrine Macé 14 , Rick Zhang 15 , Franck Dubin 14 , Mony Chenda Morisse 15 , Kenneth C Anderson 16
Abstract
The primary and pre-specified updated analyses of ICARIA-MM (NCT02990338) demonstrated improved progression-free survival and a benefit in overall survival (OS) was reported with the addition of isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide-dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma. Here, we report the final OS analysis.
This multicenter, randomized, open-label, phase 3 study included patients who had received and failed ≥2 previous therapies, including lenalidomide and a proteasome inhibitor. Between January 10, 2017, and February 2, 2018, 307 patients were randomized (1:1) to isatuximab-pomalidomide- dexamethasone (Isa-Pd; n = 154) or Pd (n = 153), stratified based on age (3). At data cutoff for the final OS analysis after 220 OS events (January 27, 2022), median follow-up duration was 52.4 months.
Median OS (95% confidence interval) was 24.6 months (20.3-31.3 months) with Isa-Pd and 17.7 months (14.4-26.2 months) with Pd (hazard ratio = 0.78; 95% CI, 0.59-1.02; 1-sided P = 0.0319). Despite subsequent daratumumab use in the Pd group and its potential benefit on PFS in the first subsequent therapy line, median PFS2 was significantly longer with Isa-Pd vs. Pd (17.5 vs. 12.9 months; log-rank 1-sided P = 0.0091).
In this analysis, Isa-Pd continued to be efficacious and well tolerated after follow-up of approximately 52 months, contributing to a clinically meaningful, 6.9-month improvement in median overall survival in patients with relapsed/refractory multiple myeloma.
CITA DEL ARTÍCULO Haematologica. 2024 Feb 1. doi: 10.3324/haematol.2023.284325
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