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Oncologic Drugs Advisory Committee on MTP for Osteosarcoma

Oncologic Drugs Advisory Committee on MTP for Osteosarcoma. IDM Pharma, Inc. May 9, 2007 Silver Spring, MD. 2001.01. Bonnie Mills, PhD. Vice President, Clinical Operations IDM Pharma. 2002.01. MTP Sponsors. Ciba-Geigy 1988-1996 Non-clinical and Phase 1/2 studies NCI 1993-1997

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Oncologic Drugs Advisory Committee on MTP for Osteosarcoma

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  1. Oncologic Drugs Advisory CommitteeonMTP for Osteosarcoma IDM Pharma, Inc. May 9, 2007Silver Spring, MD 2001.01

  2. Bonnie Mills, PhD Vice President, Clinical Operations IDM Pharma 2002.01

  3. MTP Sponsors Ciba-Geigy 1988-1996 Non-clinical and Phase 1/2 studies NCI 1993-1997 Cooperative Group Phase 3 trial Jenner Biotherapies 1996-2003 IDM 2003-present Completed Phase 3 primary final analysis 2004 Submitted NDA 2006 2008.01

  4. Phase 3 Trial • Large, well conducted, multi-center study in osteosarcoma (NCI/COG) • Clinically meaningful effect • DFS (primary): p = 0.0245, HR = 0.76, 95% CI (0.58, 0.98) • Survival: p = 0.0183, HR = 0.68, 95% CI (0.49, 0.95) • Subset analyses support internal consistency • Confirmatory study “practically or ethically impossible” 2107.01

  5. Agenda 2011.02

  6. 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 Resources and References Software Citation: Surveillance Research Program, National Cancer Institute SEER*Stat software (www.seer.cancer.gov/seerstat) version 6.3.5. 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 (1973-2002), National Cancer Institute, DCCPS, Surveillance Research Program, Cancer Statistics Branch, released April 2005, based on the November 2004 submission. 2117.03

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