Mikhael, J. (Joseph)

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    A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma
    (Springer Nature, 2020) Lendvai, N. (Nikoletta); Gasparetto, C. (Cristina); Hari, P. (Parameswaran); Kaufman, J.L. (Jonathan L.); Ocio, E.M. (Enrique M.); Chiron, M. (Marielle); Kumar, S. (Shaji); Mikhael, J. (Joseph); Bensinger, W. (William); Martin, T. (Thomas); Vij, R. (Ravi); Oprea, C. (Corina); Zonder, J. (Jeffrey); Richter, J. (Joshua); Brillac, C. (Claire); Cole, C. (Craig); Dimopoulos, M.A. (Meletios A.); San-Miguel, J.F. (Jesús F.); Charpentier, E. (Eric)
    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 nonhematologic 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.