MELACINE® Vaccine

3/14/02


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Table of Contents

MELACINE® Vaccine

Background for Intermediate Thickness Stage II Melanoma

Brief Summary of SWOG-9035

Background for Approval of Melacine

GOAL

Issues for Further Development of Melacine as Adjuvant Therapy for Intermediate Thickness Stage II Melanoma

Issues for Further Development of Melacine as Adjuvant Therapy for Intermediate Thickness Stage II Melanoma (cont’d)

Outline of Presentation

Overview of Melanoma

Outcome Depends on Stage: 15-Year Disease Specific Survival

Intermediate Thickness Stage II Melanoma

15-Year Disease Specific Survival: Stage II Melanoma - New AJCC Staging System

Options for Adjuvant Therapy of Intermediate Thickness Stage II Melanoma

Outline of Presentation

PPT Slide

Clinical Development of Melacine: Advanced Stage Patients

Clinical Development of Melacine: Stage II Patients

Clinical Development of Melacine: Stage II Patients (cont’d)

Clinical Development of Melacine: Stage II Patients (cont’d)

Clinical Development of Melacine: Stage II Patients (cont’d)

Clinical Development of Melacine: Stage II Patients (cont’d)

Clinical Development of Melacine: Stage II Patients (cont’d)

Clinical Development of Melacine: Stage II Patients (cont’d)

Outline of Presentation

SWOG-9035: “RANDOMIZED TRIAL OF ADJUVANT IMMUNOTHERAPY WITH AN ALLOGENEIC MELANOMA VACCINE FOR PATIENTS WITH INTERMEDIATE THICKNESS, NODE NEGATIVE MALIGNANT MELANOMA (T3N0M0)”

SWOG-9035: Study Coordinators

SWOG-9035: Objectives

PPT Slide

SWOG-9035: Inclusion Criteria

SWOG-9035: T3N0M0

SWOG-9035: Study Design

SWOG-9035: Patient Disposition

SWOG-9035: Timing of RFS Analysis

SWOG-9035: Baseline Comparability: ITT Population (N=689)

SWOG-9035: RFS Analyses by SWOG: ITT Population (Feb 2000 Database)

SWOG-9035: RFS Analyses by SWOG: ITT Population (Feb 2000 Database)

SWOG-9035: RFS Analyses by SWOG ITT Patients (Feb 2000 Database)

SWOG-9035: RFS Analyses ITT Patients (May 2001 Database)

Association of HLA and Melacine Benefit

SWOG-9035: Frequency of Patients with the Predefined HLA Phenotypes

SWOG-9035: RFS Benefit for Melacine in Patients Expressing ? 2 of the 5 Predefined HLA Phenotypes (SWOG Analyses)

SWOG-9035: RFS Benefit for Melacine in Patients Expressing Each of the 5 Predefined HLA (SWOG Multivariate Analysis)

SWOG-9035: Vaccine Benefit in A2C3+ Patients (Feb 2000 Database)

SWOG-9035: RFS Analysis A2C3+ Patients (Feb 2000 Database)

SWOG-9035: RFS Analysis A2C3+ Patients (May 2001 Database)

SWOG-9035: RFS Analysis A2C3– Patients (May 2001 Database)

SWOG-9035: RFS Analysis Observation Patients (May 2001 Database)

5-Year RFS Estimate

SWOG-9035: Overall Survival A2C3+ Patients (May 2001 Database)

SWOG-9035: Overall Survival A2C3– Patients (May 2001 Database)

SWOG-9035: Overall Survival Observation Patients (May 2001 Database)

SWOG-9035: Summary of Follow-up Analysis by Corixa of May 2001 Database

SWOG-9035: Vaccine Safety

SWOG-9035: AE Summary

SWOG-9035: AE Summary

SWOG-9035: Summary

Human Leukocyte Antigens (HLA)

Correlation of HLA-A2 and/or -C3 with Vaccine Benefit

PPT Slide

Outline of Presentation

Issues Affecting Further Development of the Vaccine

Impact of INTRON A on Study Design

AJCC Staging System (Edition 6): Issues

Lymphatic Mapping and Sentinel Node Biopsy

Lymphatic Mapping and Sentinel Node Biopsy: Issues

Outline of Presentation

Proposed Trial: Patient Population

Major Eligibility Criteria

Proposed Stages for Second Pivotal Trial

Stratification Factors

Sample Size & Timing of Primary Analysis

PPT Slide

Endpoints

Outline of Presentation

Issues for ODAC and the FDA

Issues for ODAC and the FDA

Proposed Stages for Second Pivotal Trial

Summary

Summary (cont.)

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PPT Slide

Author: Christine Kim