Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma

9/25/01


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Table of Contents

Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma

Presentation Agenda

Zevalin™ (ibritumomab tiuxetan): Proposed Indication

Non-Hodgkin’s Lymphoma

Zevalin Regimen

IDEC

Clinical Basis for BLA

FDA Agreements

Zevalin™ (ibritumomab tiuxetan): Summary

IDEC Investigators

IDEC Investigators (cont.)

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Ibritumomab Tiuxetan (Zevalin™) Radioimmunotherapy of Non-Hodgkin’s Lymphoma

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Treatment of Relapsed or Refractory LG/F/T NHL

Toxicities of Commonly Used Regimens

Treatment of Relapsed or Refractory LG/F/T NHL

Rationale for Radioimmunotherapy in NHL

Critical Factors for Successful RIT

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Zevalin Phase I and I/II Conclusions

Zevalin Phase I/II Study (N = 51)

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Imaging and Dosimetry

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Disease Status (cont.)

Response Assessment Protocol-Defined Response Criteria

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Response Assessment International Workshop Response Criteria

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Zevalin vs Prior Therapy Analysis

Zevalin vs Prior Rituximab or Last Chemotherapy (N = 54)

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Phase III Nonhematologic AEs (N = 143)

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Absolute Neutrophil Counts (N = 349)

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Duration of Hematologic Toxicity

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Immunology

MDS/AML

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Mortality (N = 349)

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Subsequent Bone Marrow Transplantation

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Summary

Summary (cont.)

Conclusion

Presentation Agenda

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Author: Lynn Stine