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Abstract: The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ?2 prior lines. This prespecified subgroup analysis examined efficacy in patients with renal impairment (RI; estimated glomerular filtration rate <60 mL/min/1.73 m²). Isa 10 mg/kg was given intravenously once weekly in cycle 1, and every 2 weeks in subsequent 28-day cycles. Patients received standard doses of Pd. Median progression-free survival (PFS) for patients with RI was 9.5 months with Isa-Pd (n = 55) and 3.7 months with Pd (n = 49; hazard ratio [HR] 0.50; 95% confidence interval [CI], 0.30-0.85). Without RI, median PFS was 12.7 months with Isa-Pd (n = 87) and 7.9 months with Pd (n = 96; HR 0.58; 95% CI, 0.38-0.88). The overall response rate (ORR) with and without RI was higher with Isa-Pd (56 and 68%) than Pd (25 and 43%). Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ?60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively. Isa pharmacokinetics were comparable between the subgroups, suggesting no need for dose adjustment in patients with RI. In summary, the addition of Isa to Pd improved PFS, ORR and renal response rates.
Fuente: Leukemia . 2021 Feb;35(2):562-572
Publisher: Nature Publishing Group
Year of publication: 2021
No. of pages: 11
Publication type: Article
DOI: 10.1038/s41375-020-0868-z
ISSN: 0887-6924,1476-5551
Publication Url: https://doi.org/10.1038/s41375-020-0868-z
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DIMOPOULOS, MELETIOS A.
LELEU, XAVIER
MOREAU, PHILIPPE
RICHARDSON, PAUL G.
LIBERATI, ANNA MARINA
HARRISON, SIMON J.
PRINCE, H. MILES
ENRIQUE MARIA OCIO SAN MIGUEL
ASSADOURIAN, SYLVIE
CAMPANA, FRANK
MALINGE, LAURE
SÉMIOND, DOROTHÉE
VELDE, HELGI VAN DE
YONG, KWEE
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