Estamos realizando la búsqueda. Por favor, espere...
1575
37
170
28863
4397
2595
347
362
Abstract: A Phase 2 dose-finding study evaluated isatuximab, an anti-CD38 monoclonal antibody, in relapsed/refractory multiple myeloma (RRMM; NCT01084252). Patients with ?3 prior lines or refractory to both immunomodulatory drugs and proteasome inhibitors (dual refractory) were randomized to isatuximab 3 mg/kg every 2 weeks (Q2W), 10 mg/kg Q2W(2 cycles)/Q4W, or 10 mg/kg Q2W. A fourth arm evaluated 20 mg/kg QW(1 cycle)/Q2W. Patients (N = 97) had a median (range) age of 62 years (38-85), 5 (2-14) prior therapy lines, and 85% were double refractory. The overall response rate (ORR) was 4.3, 20.0, 29.2, and 24.0% with isatuximab 3 mg/kg Q2W, 10 mg/kg Q2W/Q4W, 10 mg/kg Q2W, and 20 mg/kg QW/Q2W, respectively. At doses ?10 mg/kg, median progression-free survival and overall survival were 4.6 and 18.7 months, respectively, and the ORR was 40.9% (9/22) in patients with high-risk cytogenetics. CD38 receptor density was similar in responders and non-responders. The most common non-hematologic adverse events (typically grade ?2) were nausea (34.0%), fatigue (32.0%), and upper respiratory tract infections (28.9%). Infusion reactions (typically with first infusion and grade ?2) occurred in 51.5% of patients. In conclusion, isatuximab is active and generally well tolerated in heavily pretreated RRMM, with greatest efficacy at doses ?10 mg/kg.
Fuente: Leukemia . 2020 Dec;34(12):3298-3309
Editorial: Nature Publishing Group
Año de publicación: 2020
Nº de páginas: 12
Tipo de publicación: Artículo de Revista
DOI: 10.1038/s41375-020-0857-2
ISSN: 0887-6924,1476-5551
Url de la publicación: https://doi.org/10.1038/s41375-020-0857-2
Consultar en UCrea Leer publicación
MIKHAEL, JOSEPH
RICHTER, JOSHUA
VIJ, RAVI
COLE, CRAIG
ZONDER, JEFFREY
KAUFMAN, JONATHAN L.
BENSINGER, WILLIAM
DIMOPOULOS, MELETIOS
LENDVAI, NIKOLETTA
HARI, PARAMESWARAN
ENRIQUE MARIA OCIO SAN MIGUEL
GASPARETTO, CRISTINA
KUMAR, SHAJI
OPREA, CORINA
CHIRON, MARIELLE
BRILLAC, CLAIRE
CHARPENTIER, ERIC
SAN MIGUEL, JESÚS
MARTIN, THOMAS
Volver