GLIADEL® WAFER sNDA 20-637s

1/3/02


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Table of Contents

GLIADEL® WAFER sNDA 20-637s

GLIADEL® Wafer Indication

Clinical Trials: Recurrent Malignant Glioma

Clinical Trials: Newly Diagnosed Malignant Glioma

GLIADEL® Approvals (1996-2000)

Phase III Multicenter Trials of GLIADEL® Wafer in Newly-diagnosed Malignant Glioma

GLIADEL® Wafer Proposed Indication

Agenda

Guilford Invited Guests

Overview of Primary Malignant Glioma: Clinical Features and Treatment

Primary Malignant Glioma

Primary Malignant Glioma

Primary Malignant Glioma

Glioblastoma: Treatment Outcome

Natural History of High Grade Glioma: Effects of PCV Chemotherapy

Natural History of High Grade Glioma: Effects of PCV Chemotherapy

Prognostic Factors: Primary Malignant Glioma

Limitations of Systemic BCNU

The GLIADEL® Wafer

Phase III Trial of GLIADEL® Wafer in Newly Diagnosed Malignant Glioma

6 Month Survival Recurrent GBM (8802)

Overall Survival (ITT) Primary Malignant Glioma (0190)

Clinical Experience To Date

Rationale for Phase III Study T-301

Phase III Multicenter Trials of GLIADEL® Wafer in Newly-Diagnosed Malignant Glioma

Phase III Multicenter Trials of GLIADEL® Wafer in Newly-diagnosed Malignant Glioma

Study 0190: Trial Design

Study 0190: Baseline Patient Characteristics

Overall Survival (ITT) Primary Malignant Glioma (0190)

Study 0190: Overall Survival Adjusted for Prognostic Factors - GBM Patients1

Study 0190: Efficacy Conclusions1

Study T-301: Objectives

Study T-301: Trial Design

Study T-301: Trial Design

Study T-301: Clinical Sites

Study T-301: Inclusion Criteria

Study T-301: Baseline Characteristics

Study T-301: Baseline Characteristics

Study T-301: Tumor Size*

Statistical Methodology

Outline

Features to Eliminate Bias in T-301 Study

Key Pre-specified Features in SAP

Approach to Analysis

Stratified Analysis

Stratification of Clinical Trials

Stratification by Center vs. Country

Effect of Country-of-Treatment on Survival: Placebo-Group (T-301)

PPT Slide

Assessing the Influence of Prognostic Factors on Survival

Univariable Prognostic Factors1

Multivariable Proportional Hazards Analysis (ITT)

Summary of Statistical Methodology

Phase III Multicenter Trials of GLIADEL® Wafer in Newly-Diagnosed Malignant Glioma

Study T-301: Overall Survival Analysis (ITT)

Overall Survival – Adjusted for Prognostic Factors1 – (ITT)

Study T-301: Conclusion

Study T-301: Reoperation for Disease Progression

Study T-301: Overall Survival Analysis - Reoperation for Disease Progression (ITT)

Study T-301: Secondary Efficacy Endpoints

Study T-301: Overall Survival (GBM Patients)

Study T-301: Overall Survival Adjusted for Prognostic Factors1 (GBM Patients)

Study T-301: Karnofsky Performance Decline (ITT)

Study T-301: Neuroperformance Decline (ITT)

Study T-301: Neuroperformance Decline in Speech (ITT)

Study T-301: Neuroperformance Decline in Cranial Nerves III, IV, VI (ITT)

Study T-301: Neuroperformance Decline in Motor Status (ITT)

Study T-301: Neuroperformance Decline in Cerebellar Status (ITT)

GLIADEL® Wafer Safety

Safety Summary GLIADEL® Wafer in Primary Surgery

Safety Summary GLIADEL® Wafer in Primary Surgery

Study T-301: Neurologic Adverse Events Occurring in ɱ% of Patients

Study T-301: Neurologic Adverse Events Occurring in ɱ% of Patients

Convulsions (T-301)

Healing Abnormality: Fluid, CSF or Subdural Collections (T-301)

Healing Abnormality: CSF Leak (T-301)

Healing Abnormality: Wound Dehiscence, Breakdown or Poor Healing (T-301)

Healing Abnormality: Subgaleal or Wound Effusion (T-301)

Study T-301: Intracranial Infections

Post-operative Surgical Complications: Comparison of T-301 to Published Series

Comparison of Post-operative Surgical Infections

Comparison of Post-operative Surgical Seizures

Comparison of Post-operative Surgical Hemorrhage/Stroke

Post-Operative Surgical Complications: Conclusion

GLIADEL® Wafer in Primary Malignant Glioma: Summary of Benefits and Risks

GLIADEL® Wafer in Primary Malignant Glioma: Summary of Benefits and Risks

Consistency of GLIADEL® Wafer Phase III Trial Results

Summary of Efficacy Results from Randomized Controlled Trials of GLIADEL® Wafer (ITT)

Summary of Efficacy Results from Randomized Controlled Trials of GLIADEL® Wafer (GBM)

Summary of Benefits and Risks

GLIADEL® Wafer Proposed Indication

Author: ebh