Presentation on theme: "1 Oncologic Drugs Advisory Committee on MTP for Osteosarcoma IDM Pharma, Inc. May 9, 2007 Silver Spring, MD IDM Pharma, Inc. May 9, 2007 Silver Spring,"— Presentation transcript:
1 Oncologic Drugs Advisory Committee on MTP for Osteosarcoma IDM Pharma, Inc. May 9, 2007 Silver Spring, MD IDM Pharma, Inc. May 9, 2007 Silver Spring, MD
3 MTP Sponsors Ciba-Geigy Non-clinical and Phase 1/2 studies NCI Cooperative Group Phase 3 trial Jenner Biotherapies IDM 2003-present Completed Phase 3 primary final analysis2004 Submitted NDA
4 Phase 3 Trial Large, well conducted, multi-center study in osteosarcoma (NCI/COG) Clinically meaningful effect –DFS (primary):p = , HR = 0.76, 95% CI (0.58, 0.98) –Survival: p = , HR = 0.68, 95% CI (0.49, 0.95) Subset analyses support internal consistency Confirmatory study “practically or ethically impossible”
5 AgendaAgenda Unmet NeedIan Lewis, MB ChB, FRCP, FRCPCH Paediatric and Adolescent Oncologist St James University Hospital, Leeds Product Characteristics Bonnie Mills, PhD IDM Pharma Efficacy/SafetyPaul Meyers, MD Vice-Chairman, Dept of Pediatrics Memorial Sloan-Kettering Cancer Center Statistical Interpretation Brent Blumenstein, PhD Trial Architecture Consulting Benefit/RiskEugenie Kleinerman, MD Professor and Head, Division of Pediatrics MD Anderson Cancer Center
6 Resources and References Clinical –Curt Scribner, MD –Cheryl Graham, MD Statistics –Mark Munsell –Neby Bekele, PhD Nonclinical –Olivier Faure, PhD Regulatory –Tung Koh COG Statistician –Mark Krailo, PhD Software Citation: Surveillance Research Program, National Cancer Institute SEER*Stat software (www.seer.cancer.gov/seerstat) version Data Citation: Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 9 Regs Limited-Use, Nov 2004 Sub ( ), National Cancer Institute, DCCPS, Surveillance Research Program, Cancer Statistics Branch, released April 2005, based on the November 2004 submission.