Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B cell lymphomas

Press, Oliver W.; Appelbaum, Frederick R.; Ja, Ledbetter; Martin, Patrick; Zarling, Joyce M.; Kidd, Pamela; Ed, Thomas

doi:10.1182/blood.v69.2.584.584

Cited by 311 publications

(56 citation statements)

References 26 publications

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“…In studies with other antibody treatments, relationships between pharmacokinetic values and measures of antigen burden have been observed. 11,[13][14][15][16][17] In this study, an observed relationship between the change in pharmacokinetic values and the change in peripheral blast percentages across doses did account for some of the interoccasional variability. The increase in AUC from first to second dose is probably related to the change in tumor burden.…”

Section: Discussionmentioning

confidence: 63%

Pharmacokinetics of Gemtuzumab Ozogamicin, an Antibody‐Targeted Chemotherapy Agent for the Treatment of Patients with Acute Myeloid Leukemia in First Relapse

Dowell¹,

Korth‐Bradley²,

Liu³

et al. 2001

The Journal of Clinical Pharma

124

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The purpose of this study was to characterize the pharmacokinetics of gemtuzumab ozogamicin (Mylotarg; Wyeth-Ayerst Laboratories, St. Davids, PA) in patients with acute myeloid leukemia (AML) in first relapse. Gemtuzumab ozogamicin is an antibody-chemotherapeutic conjugate characterized as antibody-targeted chemotherapy, consisting of an engineered human anti-CD33 antibody (hP67.6) linked to a potent cytotoxic agent, N-acetyl-gamma calicheamicin DMH. The pharmacokinetics of gemtuzumab ozogamicin was evaluated in 59 adult AML patients in first relapse, enrolled in a phase II study. Plasma was collected following each dose at specified times, and the pharmacokinetics was characterized by measures of hP67.6, total calicheamicin derivatives, and unconjugated calicheamicin derivatives. After administration of the first 9 mg/m2 dose of gemtuzumab ozogamicin, the pharmacokinetic parameters (mean +/- SD) of hP67.6 following the first dose were as follows: peak plasma concentration, 2.86 +/- 1.35 mg/L; AUC, 123 +/- 105 mg x h/L; t 1/2, 72.4 +/- 42.0 hours; and clearance, 0.265 +/- 0.229L/h. Increased concentrations were observed after the second dose and are believed to be due to a decrease in clearance by CD33-positive blast cells, a result of the reduced tumor burden following the first dose. The concentration profiles of calicheamicin followed the same time course as hP67.6, evidence that calicheamicin remained conjugated to the antibody and delivered to leukemic cells. No relationship was found between plasma concentration and response at the recommended dose. The pharmacokinetics of gemtuzumab ozogamicin has been characterized in AML patients receiving doses at the proposed therapeutic level.

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Section: Discussionmentioning

confidence: 63%

Pharmacokinetics of Gemtuzumab Ozogamicin, an Antibody‐Targeted Chemotherapy Agent for the Treatment of Patients with Acute Myeloid Leukemia in First Relapse

Dowell¹,

Korth‐Bradley²,

Liu³

et al. 2001

The Journal of Clinical Pharma

124

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“…15 In 1987, the experimental administration of this mouse anti-CD20 antibody to four patients with refractory, malignant B cell lymphoma was published. 16 By this time, a mouse-human chimeric anti-CD20 antibody had…”

Section: Key Basic Sciencementioning

confidence: 99%

Rituximab for Non‐Hodgkin's Lymphoma: A Story of Rapid Success in Translation

Harrison

Thalji

Greenberg

et al. 2013

Clinical Translational Sci

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Translational stories range from straightforward to complex. In this commentary, the story of the rapid and successful translation of rituximab therapy for the treatment of non-Hodgkin’s lymphoma (NHL) is examined. Development of this monoclonal antibody therapy began in the late 1980s. In 1994, rituximab received its first approval for the treatment of NHL by the United States Food and Drug Administration (FDA). Rituximab has since been approved for additional indications and has transformed medical practice. However, the social and political implications of these rapid successes are only beginning to become clear. In this commentary, key events in the rapid translation of rituximab from the bench to bedside are highlighted and placed into this historical framework. To accomplish this, the story of rituximab is divided into the following six topics, which we believe to be widely applicable to case studies of translation: (1) underlying disease, (2) key basic science, (3) key clinical studies in translation, (4) FDA approval process, (5) changes to medical practice, and (6) the social and political influences on translation.

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“…The B-cell antigen CD20 provides an excellent immunotherapeutic target for non-Hodgkin's lymphoma (NHL) because of its expression patterns [1,2]. Over 90% of B-cell tumors express CD20, and it is present exclusively on mature B cells and is further amplified in malignant B cells [3].…”

Section: Monoclonal Antibodies: a Targeted Approachmentioning

confidence: 99%

Harnessing the Energy: Development of Radioimmunotherapy for Patients with Non-Hodgkin’s Lymphoma

et al. 2009

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Radioimmunotherapy (RIT) combines the use of targeted monoclonal antibodies with radionuclides for the treatment of non‐Hodgkin's lymphoma (NHL), taking advantage of its inherent radiosensitivity. A number of trials have shown significantly higher response rates and longer progression‐free survival times in patients treated with the CD20‐targeted radioimmunoconjugate yttrium‐90‐ibritumomab tiuxetan compared with the standard of care. Furthermore, these benefits have also been shown in heavily pretreated patients who relapsed or were resistant to rituximab. Currently, a number of different treatment regimens and strategies are available for the treatment of NHL patients. Therefore, in an attempt to minimize toxicity, maximize efficacy, and improve survival, it is crucial to appropriately select patients who are good candidates for individual treatment approaches. A strategy for patient selection has been developed, including the use of existing patient assessment tools, such as the Follicular Lymphoma International Prognostic Index, to determine the optimal regimen for patients with follicular lymphoma according to their disease characteristics and physical condition. Patients who are fit make ideal candidates for potentially curative regimens, which include induction chemotherapy with or without immunotherapy followed by RIT consolidation and, potentially, maintenance therapy. Patients who are considered “compromised” would also benefit from induction treatment and RIT consolidation, with a view to reducing the lymphoma burden and decreasing the risk for disease progression. “Frail” patients would be better suited to supportive therapy to control symptoms. This paper explores factors that should be considered when assessing whether a patient is a good candidate for treatment with RIT, and aids physicians in the selection of the most appropriate therapy for each patient group.

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Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B cell lymphomas

Cited by 311 publications

References 26 publications

Pharmacokinetics of Gemtuzumab Ozogamicin, an Antibody‐Targeted Chemotherapy Agent for the Treatment of Patients with Acute Myeloid Leukemia in First Relapse

Pharmacokinetics of Gemtuzumab Ozogamicin, an Antibody‐Targeted Chemotherapy Agent for the Treatment of Patients with Acute Myeloid Leukemia in First Relapse

Rituximab for Non‐Hodgkin's Lymphoma: A Story of Rapid Success in Translation

Harnessing the Energy: Development of Radioimmunotherapy for Patients with Non-Hodgkin’s Lymphoma

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