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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).
Fuente: Leukemia, 2023, 37, 1521-1529
Publisher: Nature Publishing Group
Year of publication: 2023
No. of pages: 9
Publication type: Article
DOI: 10.1038/s41375-023-01936-7
ISSN: 0887-6924,1476-5551
Publication Url: https://doi.org/10.1038/s41375-023-01936-7
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ENRIQUE MARIA OCIO SAN MIGUEL
PERROT, AURORE
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
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