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Advani A , Coiffier B , Czuczman MS , Dreyling M , Foran J , Gine E , Gisselbrecht C , Ketterer N , Nasta S , Rohatiner A , Schmidt-Wolf IGH , Schuler M , Sierra J , Smith MR , Verhoef G , Winter JN , Boni J , Vandendries E , Shapiro M , Fayad L
Safety, Pharmacokinetics, and Preliminary Clinical Activity of Inotuzumab Ozogamicin, a Novel Immunoconjugate for the Treatment of B-Cell Non-Hodgkin's Lymphoma: Results of a Phase I Study
Journal of Clinical Oncology. 2010 Apr;28(12) :2085-2093
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Abstract
Purpose Inotuzumab ozogamicin (CMC-544) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic agent. This was a phase I study to determine the maximum-tolerated dose (MTD), safety, and preliminary efficacy of inotuzumab ozogamicin in an expanded MTD cohort of patients with relapsed or refractory CD22(+) B-cell non-Hodgkin's lymphoma (NHL). Patients and Methods Inotuzumab ozogamicin was administered intravenously as a single agent once every 3 or 4 weeks at doses ranging from 0.4 to 2.4 mg/m(2). Outcomes included MTD, safety, pharmacokinetics, response, progression-free survival (PFS), and overall survival. Results Seventy-nine patients were enrolled. The MTD was determined to be 1.8 mg/m(2). Common adverse events at the MTD were thrombocytopenia (90%), asthenia (67%), and nausea and neutropenia (51% each). The objective response rate at the end of treatment was 39% for the 79 enrolled patients, 68% for all patients with follicular NHL treated at the MTD, and 15% for all patients with diffuse large B-cell lymphoma treated at the MTD. Median PFS was 317 days (approximately 10.4 months) and 49 days for patients with follicular NHL and diffuse large B-cell lymphoma, respectively. Conclusion Inotuzumab ozogamicin has demonstrated efficacy against CD22(+) B-cell NHL, with reversible thrombocytopenia as the main toxicity. J Clin Oncol 28: 2085-2093. (C) 2010 by American Society of Clinical Oncology
Notes
Advani, Anjali Coiffier, Bertrand Czuczman, Myron S. Dreyling, Martin Foran, James Gine, Eva Gisselbrecht, Christian Ketterer, Nicolas Nasta, Sunita Rohatiner, Ama Schmidt-Wolf, Ingo G. H. Schuler, Martin Sierra, Jorge Smith, Mitchell R. Verhoef, Gregor Winter, Jane N. Boni, Joseph Vandendries, Erik Shapiro, Mark Fayad, Luis Amer soc clinical oncology Alexandria 584pf