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Clinical Trial
. 2012 May;103(5):933-8.
doi: 10.1111/j.1349-7006.2012.02241.x. Epub 2012 Mar 20.

Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma

Michinori Ogura  1 , Kiyohiko Hatake, Kiyoshi Ando, Kensei Tobinai, Kota Tokushige, Chiho Ono, Taro Ishibashi, Erik Vandendries
Affiliations
Clinical Trial

Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma

Michinori Ogura et al. Cancer Sci. 2012 May.

Abstract

Inotuzumab ozogamicin (CMC-544), a humanized anti-CD22 antibody conjugated to the potent cytotoxic antibiotic calicheamicin, _targets the CD22 antigen expressed on the majority of B-cell non-Hodgkin lymphomas. This phase I study assessed the tolerability, safety, pharmacokinetics, and preliminary efficacy of inotuzumab ozogamicin administered intravenously in combination with rituximab in Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Ten patients were administered rituximab 375 mg/m(2) followed by inotuzumab ozogamicin at the maximum tolerated dose (1.8 mg/m(2)). Treatment was repeated every 28 days up to eight cycles, or until occurrence of disease progression or intolerable toxicity. The safety profile was similar to that of inotuzumab ozogamicin monotherapy, with hematologic adverse events occurring most frequently. The most common grade three or higher adverse events were thrombocytopenia (70%), neutropenia (50%), leukopenia (30%), and lymphopenia (30%). The overall response rate was 80% (8/10; 95% CI, 44-98%). Drug exposure increased with successive doses, similar to the pharmacokinetic profiles observed in previous phase I monotherapy studies. Efficacy results suggested promising antitumor activity, and the overall findings support the continued clinical development of this therapeutic regimen in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. This trial was registered at www.ClinicalTrials.gov as NCT00724971.

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Figures

Figure 1
Figure 1
Mean concentrations of inotuzumab ozogamicin (a) and total calicheamicin (b) in serum after i.v. treatment with inotuzumab ozogamicin 1.8 mg/m2 and rituximab 375 mg/m2, 28‐day cycle. Error bars denote standard deviations. Cycle 1 (formula image); cycle 2 (formula image); cycle 3 (formula image).
See this image and copyright information in PMC

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