Detalle Publicación

Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma

Autores: Dimopoulos, M. (Autor de correspondencia); Bringhen, S.; Anttila, P.; Capra, M.; Cavo, M.; Cole, C.; Gasparetto, C.; Hungria, V.; Jenner, M.; Vorobyev, V.; Ruiz, E. Y.; Yin, J. Y.; Saleem, R.; Hellet, M.; Mace, S.; Paiva, Bruno; Vij, R.
Título de la revista: BLOOD
ISSN: 0006-4971
Volumen: 137
Número: 9
Páginas: 1154 - 1165
Fecha de publicación: 2021
This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ¿3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ¿75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cutoff, 13 (11.9%) of 109 and 15 (27.3%) of 55 patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy end point) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859; P = .008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade 3 or higher infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at as #NCT01084252.