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Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation

Abstract: Patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation (ASCT) have lower survival rates and may benefit from frontline regimens that include novel agents. This Phase 1b study (NCT02513186) evaluated preliminary efficacy, safety, and pharmacokinetics (PK) of isatuximab, an anti-CD38 monoclonal antibody, combined with bortezomib-lenalidomide-dexamethasone (Isa-VRd) in patients with NDMM ineligible for/with no intent for immediate ASCT. Overall, 73 patients received four 6-week induction cycles of Isa-VRd, then maintenance with Isa-Rd in 4-week cycles. In the efficacy population (n?=?71), the overall response rate was 98.6%, with 56.3% achieving a complete response or better (sCR/CR), and 36/71 (50.7%) patients reaching minimal residual disease negativity (10?5 sensitivity). Grade ?3 treatment-emergent adverse events (TEAEs) occurred in 79.5% (58/73) of patients but TEAEs leading to permanent study treatment discontinuation were reported in 14 (19.2%) patients. Isatuximab PK parameters were within the previously reported range, suggesting that VRd does not alter the PK of isatuximab. These data support additional studies of isatuximab in NDMM, such as the Phase 3 IMROZ study (Isa-VRd vs VRd).

Otras publicaciones de la misma revista o congreso con autores/as de la Universidad de Cantabria

 Fuente: Leukemia, 2023, 37, 1521-1529

Editorial: Nature Publishing Group

 Año de publicación: 2023

Nº de páginas: 9

Tipo de publicación: Artículo de Revista

 DOI: 10.1038/s41375-023-01936-7

ISSN: 0887-6924,1476-5551

Url de la publicación: https://doi.org/10.1038/s41375-023-01936-7

Autoría

BORIES, PIERRE

SAN-MIGUEL, JESÚS F.

BLAU, IGOR W.

KARLIN, LIONEL

MARTÍNEZ-LÓPEZ, JOAQUÍN

WANG, SONG-YAU

BRINGUEN, SARA

MARCATTI, MAGDA

MATEOS, MARÍA-VICTORIA

RODRÍGUEZ-OTERO, PAULA

OLIVA, STEFANIA

NOGAI, AXEL

LE ROUX, NADIA

DONG, LIYAN

MACÉ, SANDRINE

GASSIOT, MATTHIEU

FITZMAURICE, THOMAS

OPREA, CORINA