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At the 60th Annual Meeting of the American Hematology Society, there was an oral abstract session which focused on the novel immunotherapeutic agents in acute myeloid leukemia (AML). At this session, Jorge Cortes (member our North American Steering Committee) from the MD Anderson Cancer Center, Houston, US, presented data from an ongoing phase I dose-escalation study (NCT02674763), evaluating the safety and anti-leukemic activity of IMGN779 in patients with CD33+ relapsed/refractory (R/R) AML.
IMGN779 is a next-generation anti-CD33 antibody drug-conjugate (ADC) with a novel DNA-alkylating IGN (indolinobenzodiazepine pseudodimer) payload and a cleavable s-SPDB linker. In preclinical studies, IMGN779 has demonstrated potent anti-tumor activity in AML cell lines.
In this phase I study, 57 patients (median age = 68 years; range: 26–88) with CD33+ R/R AML received IMGN779 intravenously once every 2 weeks (Q2W; on days 1 and 15 of a 28-day cycle; n = 36) or once weekly (QW; days 1, 8, 15, and 22 of a 28-day cycle; n = 21). Dosing using the Q2W schedule began at 0.02 mg/kg and was escalated to 1.5 mg/kg (cohort 11). QW dosing was initiated at 0.39 mg/kg based on the safety data of Q2W and escalation has proceeded to 1.2 mg/kg. Patients received a median of four doses of IMGN779 (range: 1–40).
The primary objectives of this study were to establish the maximum tolerated dose and recommended phase II dose (RP2D) of IMGN779 administered as monotherapy using QW and Q2W. The secondary objectives of the study were to evaluate the safety, tolerability and preliminary efficacy of IMGN779.
In summary, IMGN779 demonstrates a manageable tolerability and anti-leukemic activity in patients with R/R AML. Jorge Cortes concluded by noting that “enrollment continues to identify the RP2D and schedule, which may warrant the further development as combination therapy in AML.”
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