A Phase I, First-in-Human Study Evaluating the Safety and Preliminary Antileukemia Activity of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Other CD123-Positive Hematologic Malignancies

CONCLUSIONS: Objective responses (CR and CRis) were seen in one third of relapsed/refractory AML patients during the initial stages of dose escalation in this first-in-human clinical trial with IMGN632, a novel CD123-targeting ADC. No dose limiting toxicities have been observed, and PK and PD data support continued dose escalation, which is ongoing.Figure 1. A. Maximum percent changes in bone marrow blasts from baseline. Patients who achieved an objective response (CR or CRi) are shown in gray. B. CD123 receptor saturation. Average saturation curves for the first four cohorts are presented.DisclosuresDaver: Karyopharm: Research Funding; ARIAD: Research Funding; ImmunoGen: Consultancy; Novartis: Research Funding; Novartis: Consultancy; Otsuka: Consultancy; Karyopharm: Consultancy; Pfizer: Research Funding; Incyte: Research Funding; Kiromic: Research Funding; Pfizer: Consultancy; Sunesis: Research Funding; Daiichi-Sankyo: Research Funding; Alexion: Consultancy; Incyte: Consultancy; Sunesis: Consultancy; BMS: Research Funding. Erba: Jazz: Consultancy, Speakers Bureau; Takeda/Millenium: Research Funding; Agios: Consultancy, Speakers Bureau; Daiichi Sankyo: Consultancy, Research Funding; Novartis: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Jazz: Consultancy, Speakers Bureau; Amgen: Research Funding; Astellas: Research Funding; Novartis: Consultancy, Speakers Bureau; Amgen: Research Funding; Immunogen: Consultancy, Research Funding; Amgen: Research Fundin...
Source: Blood - Category: Hematology Authors: Tags: 613. Acute Myeloid Leukemia: Clinical Studies: Immunotherapy and New Agents Source Type: research