| Title: |
Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis |
| Authors: |
Richardson, PG; Perrot, A; Miguel, JS; Beksac, M; Spicka, I; Leleu, X; Schjesvold, F; Moreau, P; Dimopoulos, MA; Huang, S-Y; Minarik, J; Cavo, M; Prince, HM; Macé, S; Zhang, R; Dubin, F; Morisse, MC; Anderson, KC |
| Publisher Information: |
Ferrata Storti Foundation |
| Publication Year: |
2024 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
The primary and prespecified updated analyses of ICARIA-MM (clinicaltrial gov. Identifier: NCT02990338) demonstrated improved progression-free survival (PFS) 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 III 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 was 24.6 months (95% confidence interval [CI]: 20.3-31.3) with Isa-Pd and 17.7 months (95% CI: 14.4- 26.2) 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 versus 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 OS in patients with relapsed/refractory multiple myeloma. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0390-6078 |
| Relation: |
https://hdl.handle.net/11343/345906 |
| Availability: |
https://hdl.handle.net/11343/345906 |
| Rights: |
https://creativecommons.org/licenses/by-nc/4.0 ; CC BY-NC |
| Accession Number: |
edsbas.81D01CA4 |
| Database: |
BASE |