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.)
PPT Slide
PPT Slide
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