A Phase 1 First-in-Human Study of AMG 330, an Anti-CD33 Bispecific T-Cell Engager (BiTE(R)) Antibody Construct, in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Conclusions: Preliminary data of AMG 330 dosed up to 480 μg/d provide encouraging early evidence of tolerability and anti-leukemic activity in heavily pre-treated patients with R/R AML. Expected CRS was mitigated through step-up dosing, corticosteroid pretreatment, IV fluids, tocilizumab, and drug interruption if needed; most patients had short periods of CRS which responded well to treatment. A 2-step approach will be used in the future to quickly achieve the target dose and optimize clinical response. Regarding pharmacodynamics, to date, 2 CRs and 2 CRis have been observed at target doses of 120 and 240 μg/d. As nearly all patients were substantially cytopenic at baseline, it is challenging to evaluate the impact of AMG 330 on cytopenias. Of note, both CR patients had a complete recovery of blood counts after one cycle of treatment. These promising data validate the use of the BiTE® platform to target CD33.FigureDisclosuresRavandi: Sunesis: Honoraria; Bristol-Myers Squibb: Research Funding; Abbvie: Research Funding; Bristol-Myers Squibb: Research Funding; Xencor: Research Funding; Jazz: Honoraria; Orsenix: Honoraria; Xencor: Research Funding; Jazz: Honoraria; Astellas Pharmaceuticals: Consultancy, Honoraria; Seattle Genetics: Research Funding; Macrogenix: Honoraria, Research Funding; Abbvie: Research Funding; Orsenix: Honoraria; Seattle Genetics: Research Funding; Macrogenix: Honoraria, Research Funding; Amgen: Honoraria, Research Funding, Speakers Bureau; Astella...
Source: Blood - Category: Hematology Authors: Tags: 613. Acute Myeloid Leukemia: Clinical Studies: Immunotherapy and New Agents Source Type: research