Table of Contents
Campath® (alemtuzumab)
Presentation Agenda
Attending Experts
Proposed Indication
Campath-1H
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
Conclusions
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
Safety
Efficacy
Campath: Benefit /Risk
Proposed Indication
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