Abstract
Overview
Introduction
The incidence of multiple myeloma is forecast to total 40,885 cases across the seven major pharmaceutical markets in 2007. Current drug therapy is planned around stem cell transplantation. The recent approval of three new agents-Thalomid (thalidomide; Celgene), Revlimid (lenalidomide; Celgene) and Velcade (bortezomib; Millenium/Johnson & Johnson)-has significantly advanced treatment.
Scope
- Multiple myeloma epidemiology, disease features and progress in current treatment
- Remaining unmet needs in the treatment of multiple myeloma
- Research and analysis of the multiple myeloma pipeline with in-depth clinical and commercial assessment of Phase III drug candidates
- Stakeholder opinions based on qualitative interviews with key opinion leaders from the US and EU
Report Highlights
The approval of three new agents, Thalomid (thalidomide; Celgene), Revlimid (lenalidomide; Celgene) and Velcade (bortezomib; Millenium/Johnson & Johnson), has significantly changed the MM treatment approach for both newly diagnosed and relapsed/refractory disease.
Despite the recent advances in treatment, MM remains largely incurable as disease relapse is inevitable. There remains a strong need for more efficacious and tolerable drugs that affect new therapeutic targets and enhance patient outcomes.
There is great opportunity for novel agents to enter the myeloma market as patients often require multiple lines of therapy. Furthermore, the major approach to myeloma drug therapy is the use of combined regimens. A drug that shows potential synergistic activity with other approved or emerging drugs would be well received.
Reasons to Purchase
- Gain an insight into the epidemiology trends and disease characteristics of multiple myeloma
- Analyze the current status of multiple myeloma treatment and consider the remaining unmet needs
- Acquire a detailed appreciation and impartial perspective of the multiple myeloma pipeline and identify the key products in late-phase development
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
- Diagnosis and clinical manifestations of MM
- 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
- Thalomid (thalidomide)
- 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
- Panobinostat (Novartis)
- 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
- Actimid (pomalidomide, Celgene)
- Multiple myeloma pipeline overview
- 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
- Bibliography
