Campath® (alemtuzumab)


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Table of Contents

Campath® (alemtuzumab)

Presentation Agenda

Attending Experts

Proposed Indication


Mechanism of Action

Historical Timeline

Overview of CLL: Need for New Therapeutic Options

Chronic Lymphocytic Leukemia (CLL)

Rai Staging

Complications of Progressive CLL

Standard Treatments in CLL

Benefits of Treatment to Patients

Second Line Fludarabine: Published Experience

Outcomes of Second Line Fludarabine Therapy

Experience in Patients Who Have Failed Fludarabine

Published Experience: Investigational Salvage Therapy Following Fludarabine Failure


Campath: Presentation of Clinical Data

Presentation Outline

Campath Development in CLL

Campath Pivotal and Supportive Studies (30 mg 3x/week)

Efficacy Results

Analysis of Supportive Studies

Baseline Characteristics

Independent Expert Panel Review

Formal Response Assessment NCIWG Criteria (1996)a

Independent Panel Response Assessment (NCIWG 1996)

Time to Event Parameters - Responders

PPT Slide

Discussions with FDA: Design of CAM211 Pivotal Study

Rationale for Single-Arm Study Design

Prior Therapy

Criteria for Treatment: NCIWG

Primary Endpoint

Secondary Endpoints

I.V. Administration

Concomitant Therapy

Baseline Characteristics

Therapy After Failing Fludarabine

Response Assessment

Response Assessment (ITT; N=93)

Time to Event Parameters (Responders N=31)

Kaplan-Meier Survival Curve All Patients

Response Rate & 95% CI for the Pivotal and Supportive Studies

Median Survival for Pivotal and Supportive Studies

Clinical Benefit Evaluation

Important Clinical Benefit Parameters

Clinical Benefits in Responders (N=31)

Clinical Benefits in Responders (N=31)

Summary of Clinical Benefit

Efficacy Summary (CAM211)

Presentation Outline

Integrated Safety Database (N=149)

Demographics of Safety Population

On-Study Adverse Events

On-Study Deaths (within 30 days of last dose)

Post-Study Deaths (ᡖ days but within 180 days of Campath last dose)

Most Common Adverse Events

Rate of Acute Infusion-Related Adverse Events by Week on Treatment

Acute Infusion Related Adverse Events

On-Study Grade 3/4 Infections

On-Study Grade 3 or 4 Pneumonias

Definition of Opportunistic Infections

Opportunistic Infections

Incidence of PCP and Herpes Zoster: Impact of Prophylaxis

Median CD4 Cell Counts Over Time On Study (CAM211)

Pancytopenia: Adverse Event or Study Discontinuation

Median Hematological Parameters (Last Value Carried Forward)

Baseline Hematologic Parameters by Rai Stage

Incidence of Grade 4 Cytopenias by Baseline Rai Stage (from Baseline Grade 0-2)

Grade 4 Neutropenia by Rai Stage

Hematologic Toxicity: Summary

Campath: Extent of Exposure

Fludara® Label: Safety

Presentation Outline



Campath: Benefit /Risk

Proposed Indication

Author: Preferred Customer