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A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma

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

Autores/as

MIKHAEL, JOSEPH

RICHTER, JOSHUA

VIJ, RAVI

COLE, CRAIG

ZONDER, JEFFREY

KAUFMAN, JONATHAN L.

BENSINGER, WILLIAM

DIMOPOULOS, MELETIOS

LENDVAI, NIKOLETTA

HARI, PARAMESWARAN

GASPARETTO, CRISTINA

KUMAR, SHAJI

OPREA, CORINA

CHIRON, MARIELLE

BRILLAC, CLAIRE

CHARPENTIER, ERIC

SAN MIGUEL, JESÚS

MARTIN, THOMAS