Stakeholder Opinions: Multiple Myeloma - Exploring new targets for multiple drug therapy

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Oncology pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Datamonitor insight into the multiple myeloma market
  • Related reports
  • Upcoming reports
• CHAPTER 2 MULTIPLE MYELOMA OVERVIEW
  • Introduction
  • The underlying biology of multiple myeloma
    • Genetic abnormalities are characteristic of multiple myeloma cells
    • Multiple myeloma cells interact with the bone marrow environment to trigger molecular events
  • Diagnosis, classification and staging of multiple myeloma
    • Diagnosis and clinical manifestations of MM
      • Clinical features arise through the infiltration of malignant cells in the bone marrow
    • Disease classification
      • Monoclonal gammopathy of undetermined significance
      • Smoldering myeloma
      • Symptomatic disease
    • The International Staging System improves disease assessment
  • Risk factors
    • Age, gender and race
  • Epidemiology
    • Crude incidence of multiple myeloma
    • Forecast incidence of multiple myeloma to 2016
    • Incidence of multiple myeloma by country in 2007
    • Poor survival rates for multiple myeloma patients
    • Multiple myeloma is a disease of old age
• CHAPTER 3 CURRENT MULTIPLE MYELOMA TREATMENT OPTIONS
  • Multiple myeloma treatment overview
  • Conventional therapies
    • Melphalan and prednisone
    • Dexamethasone
    • VAD and DVD regimens
  • Novel therapies
    • Thalomid (thalidomide)
      • Thalomid and dexamethasone
      • Thalomid and melphalan/prednisone
    • Revlimid (lenalidomide)
      • Revlimid and dexamethasone
      • Revlimid and melphalan/prednisone
      • Ongoing clinical trials
    • Velcade (bortezomib)
      • Velcade and Doxil
      • Velcade versus dexamethasone in relapsed/refractory MM patients
      • Velcade, melphalan/prednisone and Thalomid in relapsed patients
      • Ongoing clinical trials
      • First-line Velcade approval is likely
  • Stem cell transplantation
  • Maintenance therapy
  • Treatment of relapsed/refractory disease
  • Supportive care
• CHAPTER 4 UNMET NEEDS
  • Multiple myeloma remains largely incurable
  • Optimal sequencing of drugs across different lines of therapy remains undetermined
  • Drugs with lower toxicities required for use in all MM patients
  • More novel therapies required for relapsed MM
  • Summary of unmet needs
• CHAPTER 5 PIPELINE ANALYSIS
  • Multiple myeloma pipeline overview
    • Phase III product pipeline for multiple myeloma
    • Phase II product pipeline for multiple myeloma
    • Phase I product pipeline for multiple myeloma
  • Phase III drug profiles
    • Panobinostat (Novartis)
      • Key historical events
      • Clinical trials
      • Datamonitor comments
    • Tanespimycin (Kosan Biosciences)
      • Key historical events
      • Clinical trial data
      • Datamonitor comments
  • Key Phase II drug profiles
    • Actimid (pomalidomide, Celgene)
      • Key historical events
      • Clinical trials
      • Datamonitor comments
    • Alvocidib (flavopiridol, Sanofi-Aventis)
      • Key historical events
      • Clinical trials
      • Datamonitor comments
    • Denosumab (Amgen)
      • Key historical events
      • Clinical trials
      • Datamonitor comments
    • Romidepsin (Gloucester Pharmaceuticals/Astellas)
      • Key historical events
      • Clinical trials
      • Datamonitor comments
    • Torisel (temsirolimus, Wyeth)
      • Key historical events
      • Clinical trials
      • Datamonitor comments
    • VEGF inhibitors in Phase II development
      • Aplidin (plitidepsin, PharmaMar)
      • Aflibercept (VEGF Trap, Regeneron/Sanofi-Aventis)
      • Avastin (bevacizumab; Genentech/Roche)
      • Nexavar (sorafenib, Bayer/Onyx Pharmaceuticals)
      • Clinical development of VEGF inhibitors
      • Datamonitor comments
• APPENDIX A
  • Bibliography
    • Journals
    • Websites
    • Other
  • Key opinion leaders interviewed
  • Abbreviations
  • List of tables
  • List of figures
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the Oncology analysis team
  • Disclaimer
  • List of Tables
    • Table 1: Clinical features of MM
    • Table 2: Disease classification of MM
    • Table 3: The International Staging System for MM
    • Table 4: The Durie-Salmon staging system for MM
    • Table 5: Crude incidence rates (per 100,000) of MM, 2002
    • Table 6: Forecast incidence of MM, 2002-16
    • Table 7: Drugs approved for use in MM
    • Table 8: Phase III trial results for Thalomid combined with dexamethasone in patients with newly diagnosed MM
    • Table 9: Phase III trials of Thalomid and MP in elderly patients with MM
    • Table 10: Phase I/II study results of Revlimid and melphalan/prednisone therapy in newly diagnosed MM patients
    • Table 11: Ongoing Phase III trials for Revlimid therapy in MM
    • Table 12: Approved indications for Velcade in MM
    • Table 13: Phase I/II trials results of Velcade, melphalan/prednisone and Thalomid combined therapy in relapsed/refractory MM patients
    • Table 14: Ongoing Phase III trials for Velcade therapy in MM
    • Table 15: Supportive care therapies in MM
    • Table 16: MM treatment toxicities
    • Table 17: Pipeline drugs in Phase III development for multiple myeloma, 2007
    • Table 18: Pipeline drugs in Phase II development for multiple myeloma, 2007
    • Table 19: Pipeline drugs in Phase I development for multiple myeloma, 2007
    • Table 20: Panobinostat: key historical events
    • Table 21: Ongoing clinical trials for panobinostat in MM, 2007
    • Table 22: Tanespimycin: key historical events
    • Table 23: Ongoing clinical trials for tanespimycin in MM, 2007
    • Table 24: Phase I trial results for tanespimycin and Velcade in relapsed MM patients
    • Table 25: Actimid: key historical events
    • Table 26: Ongoing Phase II trial for Actimid in MM, 2007
    • Table 27: Phase I/II trial results for Actimid in MM
    • Table 28: Alvocidib: key historical events
    • Table 29: Ongoing clinical trials for alvocidib in MM, 2007
    • Table 30: Denosumab: key historical events
    • Table 31: Ongoing Phase II trial for denosumab in MM, 2007
    • Table 32: Romidepsin: key historical events
    • Table 33: Ongoing clinical trials for romidepsin in MM, 2007
    • Table 34: Torisel: key historical events
    • Table 35: Ongoing clinical trials for Torisel in MM, 2007
    • Table 36: Aplidin: key historical events
    • Table 37: Aflibercept: key historical events
    • Table 38: Avastin: key historical events
    • Table 39: Nexavar: key historical events
    • Table 40: Ongoing clinical trials for VEGF inhibitors in MM, 2007
    • Table 41: Abbreviations used in Stakeholder Opinions: Multiple Myeloma, 2007
  • List of Figures
    • Figure 1: B-cells develop into antibody-producing plasma cells
    • Figure 2: The formation of malignant plasma cells in MM
    • Figure 3: Inducible molecular events triggered by the interaction of MM cells and bone marrow milieu
    • Figure 4: MM incidence forecast, 2007-16
    • Figure 5: Incidence of MM in the seven major pharmaceutical markets, 2007
    • Figure 6: Survival rates over 10 years for MM patients in the US
    • Figure 7: Incidence rates (per 100,000) of MM according to age in the US
    • Figure 8: Treatment of newly diagnosed MM
    • Figure 9: Two Phase III trials of Revlimid therapy in patients with relapsed/refractory MM
    • Figure 10: Phase III trial results of Revlimid and dexamethasone in newly diagnosed MM patients
    • Figure 11: Phase III trial results for Revlimid and low dose versus high dose dexamethasone in newly diagnosed MM patients
    • Figure 12: Phase III trials results of second-line Doxil plus Velcade therapy in patients with relapsed/refractory MM
    • Figure 13: APEX study-randomized Phase III trial of Velcade therapy in patients with relapsed MM
    • Figure 14: Preliminary Phase III trial results for Velcade, Thalomid and dexamethasone in MM patients undergoing ASCT
    • Figure 15: Characteristics of MM disease progression
    • Figure 16: The MM product development pipeline
    • Figure 17: Summary of unmet needs in MM
    • Figure 18: Multiple mechanisms of HDAC inhibitors in tumor cells
    • Figure 19: Phase II trial results for alvocidib in relapsed/refractory MM patients