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

PRLog (Press Release) - Dec 24, 2007 -
Scope of this report
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
Research and analysis 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.
Key reasons to read this report
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
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

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