Abstract
Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) versus Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate <60 mL/min/1.73 m2. Addition of Isa prolonged progression-free survival (PFS) in patients with RI (hazard ratio: 0.27; 95% confidence interval [CI]: 0.11–0.66; median PFS not reached for Isa-Kd versus 13.4 months for Kd [20.8-month follow-up]). Complete renal responses occurred more frequently with Isa-Kd (52.0%) versus Kd (30.8%) and were durable in 32.0% versus 7.7% of patients, respectively. Treatment exposure was longer with Isa-Kd, with median number of started cycles and median duration of exposure of 20 versus 9 cycles and 81.0 versus 35.7 weeks for Isa-Kd versus Kd, respectively. Among patients with RI, the incidence of patients with grade ≥3 treatment-emergent adverse events was similar between the two arms (79.1% in Isa-Kd vs. 77.8% in Kd). In summary, the addition of Isa to Kd improved clinical outcomes with a manageable safety profile in patients with RI, consistent with the benefit observed in the overall IKEMA study population.
| Original language | English |
|---|---|
| Pages (from-to) | 1397-1409 |
| Number of pages | 13 |
| Journal | Haematologica |
| Volume | 107 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 2022 |
Bibliographical note
Funding Information:MC is part of the speaker’s bureau of Amgen, Janssen, and Sanofi. TM has received research funding from Amgen, Janssen, and Sanofi; consults for GSK. PM has received honoraria from Amgen, Celgene, Janssen, Novartis, and Takeda; has a consulting or advisory role at Amgen, Cel-gene, Janssen, Novartis, and Takeda. RB has received research funding from AbbVie, Acerta Pharma, Alexion, Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, CSL Behring, Daiichi Sankyo, Janssen-Cilag, Mor-phoSys AG, Pfizer, Rigel Pharmaceuticals, Roche, Sanofi, and Takeda; has received honoraria from Bayer; has a consulting or advisory role at Janssen-Cilag, Roche; is part of the speaker’s bureau of Bayer. LP, C-KM, MRS, and MT have no conflicts of interest to disclose. XL has received honoraria from AbbVie, Amgen, Bristol Myers Squibb, Carsgen Therapeutics Ltd, Celgene, Gilead Sciences, Janssen-Cilag, Karyopharm Therapeutics, Merck, Mundipharma, Novartis, Oncopeptides, Pierre Fabre, Roche, Sanofi, and Takeda; has received non-financial support from Takeda. MM has received research funding from Adaptive, Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Jazz,
Funding Information:
The IKEMA study was sponsored by Sanofi. We thank the participating patients and their caregivers, and the study centers and investigators for their contributions to the study. Medical writing support was provided by C. Semighini Grubor, PhD, and S. Mariani, MD, PhD, of Elevate Medical Affairs, contracted by Sanofi Genzyme, for publication support services.
Publisher Copyright:
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