Stakeholder Insight: Acute Leukemias - Reaching the Limits of Cytotoxic Chemotherapy

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1 Brochure More information from Stakeholder Insight: Acute Leukemias - Reaching the Limits of Cytotoxic Chemotherapy Description: The drug therapy of acute myeloid leukemia (AML) and adult acute lymphoblastic leukemia (ALL) is largely based on chemotherapy regimens that have changed little in the past few decades. Patient outcomes for both diseases remain poor, particularly for elderly and high-risk patients. As the limits of cytotoxic chemotherapy are being reached, an unmet need remains for novel, improved therapies. Scope - Analysis of the AML and adult ALL market based on a survey of 180 acute leukemia specialists, supported by interviews with key opinion leaders. - Segmentation of the AML and adult ALL populations by age group and risk group, respectively - In-depth analysis of treatment patterns, regimens prescribed and treatment outcomes for AML and adult ALL by age group and risk group, respectively - Discussion of unmet needs and overview of late-stage pipeline drugs and marketed drugs investigated for expansion into the AML and adult ALL settings Highlights of this title The only molecular targeted therapy approved for use in AML is Mylotarg (gemtuzumab ozogamicin; Wyeth) but it's use is limited to elderly, relapsed patients who are not candidates for other chemotherapy. A number of molecular targeted therapies are currently in development for AML but are expected to have minimal impact on patient outcomes. Gleevec (imatinib; Novartis) is the only molecular targeted therapy used extensively in the treatment of adult ALL. To date, the second generation tyrosine kinase inhibitors Sprycel (dasatinib; Bristol-Myers Squibb) and Tasigna (nilotinib; Novartis) have limited use in the treatment of the disease. Hematopoietic stem cell transplantation (HSCT) has a central role in the management of both AML and adult ALL. However, it remains an underutilized procedure and its use is often delayed beyond its optimal timing. Research efforts are required to optimize the use of this potentially curative approach. Key reasons to purchase this title - Understand prescribing trends in the AML and adult ALL markets - Examine unmet need within the AML and adult ALL markets and identify opportunities for new product development - Enhance commercial positioning by increasing understanding of current dynamics within the AML and adult ALL markets Contents: CHAPTER 1 EXECUTIVE SUMMARY Scope of the analysis Datamonitor insight into the acute leukemias market Datamonitor insight into the AML market Datamonitor insight into the adult ALL market Contributing experts Related reports

2 Upcoming reports CHAPTER 2 INTRODUCTION AND SCOPE Coverage of the Stakeholder Insight Survey Disease definition and epidemiology Segmentation of the acute leukemia population Current drug treatment practice for AML and adult ALL Key unmet needs within the AML and adult ALL market Overview of pipeline drugs for AML and adult ALL CHAPTER 3 AML: COUNTRY TREATMENT TREES Introduction Acute myeloid leukemia (AML) country treatment trees US Japan France Germany Italy Spain UK CHAPTER 4 AML: PATIENT SEGMENTATION AND EPIDEMIOLOGY Key findings Definition of acute myeloid leukemia (AML) AML is a disease of older age Presentation and diagnosis Symptoms can vary for AML patients Segmentation of the acute myeloid leukemia (AML) population Two classification systems are used in AML Cytogenetics is the most important prognostic factor Age is a major determinant of survival Epidemiology of acute myeloid leukemia (AML) AML accounts for about 30-35% of all leukemias in the seven major markets Forecast incidence of AML in the seven major markets, CHAPTER 5 AML: TREATMENT TRENDS Key findings Summary of acute myeloid leukemia (AML) treatment strategies Treatment rates Induction treatment Induction treatment overview Induction treatment trends in patients less than 60 years old Standard-dose cytarabine with idarubicin is the most popular regimen There is a low uptake of the hypomethylating agents Vidaza and Dacogen Induction treatment trends in patients aged 60 or above The treatment of older AML patients deviates from treatment guidelines The uptake of Vidaza and Dacogen is significant in the US Post-induction treatment Post-induction treatment overview Post-induction treatment trends in patients less than 60 years old Post-induction treatment trends in patients aged 60 or above Consolidation treatment Consolidation treatment overview Consolidation treatment trends in patients less than 60 years old Consolidation treatment trends in patients aged 60 or above Relapse treatment Relapse treatment overview Relapse treatment trends in patients less than 60 years old Relapse treatment trends in patients aged 60 or above Mylotarg accounts for about 10% of the market in older, relapsed AML patients Hematopoietic stem cell transplantation in acute myeloid leukemia (AML) CHAPTER 6 AML: IMPROVING TREATMENT OUTCOMES Key findings Treatment outcomes Unmet needs More effective therapies are required for AML HSCT remains an underutilized procedure

3 Molecular markers may help improve risk-adapted therapeutic strategies New product development A number of new approaches are being investigated in AML Novel drugs in Phase III development for AML Onrigin (laromustine; Vion) Zarnestra (tipifarnib; Johnson & Johnson) Amonafide malate (AS1413; Antisoma) Midostaurin (Novartis) PR1 peptide antigen vaccine (The Vaccine Company) Selected marketed drugs investigated in AML Clolar (clofarabine; Genzyme) Dacogen (decitabine; Eisai/Johnson & Johnson) Vidaza (azacitidine; Celgene) Trisenox (arsenic trioxide; Cephalon) CHAPTER 7 ALL: COUNTRY TREATMENT TREES Introduction Acute lymphoblastic leukemia (ALL) country treatment trees US Japan France Germany Italy Spain UK CHAPTER 8 ALL: PATIENT SEGMENTATION AND EPIDEMIOLOGY Definition of acute lymphoblastic leukemia (ALL) ALL represents less than 1% of all adult cancers Genetic alterations provide insight into the pathogenesis of ALL Presentation and diagnosis Non-specific syndromes are common in ALL Segmentation of the ALL population The classification of ALL is still evolving Patients are usually stratified according to risk Age: treatment outcomes decline with increasing patient age Immunophenotype: the outcome of T-lineage ALL is more favorable Cytogenetics and molecular genetics: the Philadelphia chromosome Response to therapy: early response to treatment is a critical prognostic factor Epidemiology of ALL ALL accounts for about 10-15% of all leukemias in the seven major markets Forecast incidence of ALL in the seven major markets, CHAPTER 9 ALL: TREATMENT TRENDS Summary of acute lymphoblastic leukemia (ALL) treatment strategies Treatment rates Induction treatment Induction treatment overview The treatment of Philadelphia chromosome-positive ALL Induction treatment trends A vincristine-corticosteroid combination is the backbone of induction therapy The toxicity of asparaginase compromises its use HyperCVAD is a standard induction therapy in the US Gleevec is the only molecular targeted therapy used extensively in the induction treatment of adult ALL Consolidation treatment Consolidation treatment overview Consolidation treatment trends Consolidation therapy of standard-risk ALL patients is largely based on methotrexate Gleevec is used as a consolidation therapy in Ph+ patients who cannot receive a stem cell transplant Maintenance treatment Maintenance treatment overview Maintenance treatment trends A very small, off-label use of Tasigna is taking place in the maintenance setting Clinical trials in ALL Hematopoietic stem cell transplantation in ALL CHAPTER 10 ALL: IMPROVING TREATMENT OUTCOMES

4 Treatment outcomes Unmet needs More effective therapies are required for adult ALL Research efforts should focus on older ALL patients Prognostic markers are required for risk-adapted therapeutic strategies New product development R&D activity in ALL is limited Novel drugs in late-phase development for adult ALL Marqibo (liposomal vincristine; Hana BioSciences) Selected marketed drugs investigated in adult ALL Arranon (nelarabine; GlaxoSmithKline) Clolar (clofarabine; Genzyme) Rituxan (rituximab; Biogen Idec/Genentech/Roche) BIBLIOGRAPHY Journals Websites Datamonitor reports APPENDIX A List of tables List of figures Physician research methodology Physician sample breakdown US Japan France Germany Italy Spain UK Contributing experts APPENDIX B The survey questionnaire About Datamonitor About Datamonitor Healthcare About the Oncology analysis team Disclaimer List of Figures Figure 1: Acute myeloid leukemia (AML) incidence and patient segmentation data in the US for patients less Figure 2: Acute myeloid leukemia (AML) incidence and patient segmentation data in the US for patients aged 60 or older, 2009 Figure 3: Acute myeloid leukemia (AML) treatment data in the US for patients less Figure 4: Acute myeloid leukemia (AML) treatment data in the US for patients aged 60 or older, 2009 Figure 5: Acute myeloid leukemia (AML) incidence and patient segmentation data in Japan for patients less Figure 6: Acute myeloid leukemia (AML) incidence and patient segmentation data in Japan for patients aged 60 or older, 2009 Figure 7: Acute myeloid leukemia (AML) treatment data in Japan for patients less Figure 8: Acute myeloid leukemia (AML) treatment data in Japan for patients aged 60 or older, 2009 Figure 9: Acute myeloid leukemia (AML) incidence and patient segmentation data in France for patients less Figure 10: Acute myeloid leukemia (AML) incidence and patient segmentation data in France for patients aged 60 or older, 2009 Figure 11: Acute myeloid leukemia (AML) treatment data in France for patients less Figure 12: Acute myeloid leukemia (AML) treatment data in France for patients aged 60 or older, 2009 Figure 13: Acute myeloid leukemia (AML) incidence and patient segmentation data in Germany for patients less Figure 14: Acute myeloid leukemia (AML) incidence and patient segmentation data in Germany for patients aged 60 or older, 2009 Figure 15: Acute myeloid leukemia (AML) treatment data in Germany for patients less than 60 years old, 2009 Figure 16: Acute myeloid leukemia (AML) treatment data in Germany for patients aged 60 or older, 2009 Figure 17: Acute myeloid leukemia (AML) incidence and patient segmentation data in Italy for patients less

5 Figure 18: Acute myeloid leukemia (AML) incidence and patient segmentation data in Italy for patients aged 60 or older, 2009 Figure 19: Acute myeloid leukemia (AML) treatment data in Italy for patients less Figure 20: Acute myeloid leukemia (AML) treatment data in Italy for patients aged 60 or older, 2009 Figure 21: Acute myeloid leukemia (AML) incidence and patient segmentation data in Spain for patients less Figure 22: Acute myeloid leukemia (AML) incidence and patient segmentation data in Spain for patients aged 60 or older, 2009 Figure 23: Acute myeloid leukemia (AML) treatment data in Spain for patients less Figure 24: Acute myeloid leukemia (AML) treatment data in Spain for patients aged 60 or older, 2009 Figure 25: Acute myeloid leukemia (AML) incidence and patient segmentation data in the UK for patients less Figure 26: Acute myeloid leukemia (AML) incidence and patient segmentation data in the UK for patients aged 60 or older, 2009 Figure 27: Acute myeloid leukemia (AML) treatment data in the UK for patients less Figure 28: Acute myeloid leukemia (AML) treatment data in the UK for patients aged 60 or older, 2009 Figure 29: Age distribution of acute myeloid leukemia (AML) patients Figure 30: Percentage distribution of leukemia subtypes in the US, Japan and the five major EU markets, 2009 Figure 31: Average treatment rate for acute myeloid leukemia (AML) patients less than 60 years old in the seven major pharmaceutical markets, 2009 Figure 32: Average treatment rate for acute myeloid leukemia (AML) patients aged 60 or above in the seven major pharmaceutical markets, 2009 Figure 33: Top three chemotherapy regimens used in the induction therapy of acute myeloid leukemia (AML) patients less than 60 years old in the seven major pharmaceutical markets, 2009 Figure 34: Top three chemotherapy regimens used in the induction therapy of acute myeloid leukemia (AML) patients aged 60 or above in the seven major pharmaceutical markets, 2009 Figure 35: Uptake of Dacogen and Vidaza in the treatment of acute myeloid leukemia (AML) in the US, 2009 Figure 36: Top three chemotherapy regimens used in the post-induction therapy of acute myeloid leukemia (AML) patients less than 60 years old in the seven major pharmaceutical markets, 2009 Figure 37: Top three chemotherapy regimens used in the post-induction therapy of acute myeloid leukemia (AML) patients aged 60 or above in the seven major pharmaceutical markets, 2009 Figure 38: Top three chemotherapy regimens used in the consolidation therapy of acute myeloid leukemia (AML) patients less than 60 years old in the seven major pharmaceutical markets, 2009 Figure 39: Top three chemotherapy regimens used in the consolidation therapy of acute myeloid leukemia (AML) patients aged 60 or above in the seven major pharmaceutical markets, 2009 Figure 40: Top three chemotherapy regimens used in the relapse therapy of acute myeloid leukemia (AML) patients less than 60 years old in the seven major pharmaceutical markets, 2009 Figure 41: Top three chemotherapy regimens used in the relapse therapy of acute myeloid leukemia (AML) patients aged 60 or above in the seven major pharmaceutical markets, 2009 Figure 42: Uptake of Mylotarg in the treatment of acute myeloid leukemia (AML) in patients aged under 60 and in patients aged 60 or above, 2009 Figure 43: Average use of hematopoietic stem cell transplantation (HSCT) in the induction, post-induction, consolidation, and relapse treatment of AML in the seven major pharmaceutical markets, 2009 Figure 44: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in the US, 2009 Figure 45: Adult acute lymphoblastic leukemia (ALL) treatment data in the US, 2009 Figure 46: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in Japan, 2009 Figure 47: Adult acute lymphoblastic leukemia (ALL) treatment data in Japan, 2009 Figure 48: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in France, 2009 Figure 49: Adult acute lymphoblastic leukemia (ALL) treatment data in France, 2009 Figure 50: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in Germany, 2009 Figure 51: Adult acute lymphoblastic leukemia (ALL) treatment data in Germany, 2009 Figure 52: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in Italy, 2009 Figure 53: Adult acute lymphoblastic leukemia (ALL) treatment data in Italy, 2009 Figure 54: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in Spain, 2009 Figure 55: Adult acute lymphoblastic leukemia (ALL) treatment data in Spain, 2009 Figure 56: Adult acute lymphoblastic leukemia (ALL) incidence and patient segmentation data in the UK, 2009 Figure 57: Adult acute lymphoblastic leukemia (ALL) treatment data in the UK, 2009 Figure 58: Risk stratification of adult acute lymphoblastic leukemia (ALL) patients in the seven major pharmaceutical markets, 2009 Figure 59: Philadelphia chromosome status in high-risk adult acute lymphoblastic leukemia (ALL) patients in

6 the seven major pharmaceutical markets, 2009 Figure 60: Percentage distribution of leukemia subtypes in the US, Japan and the five major EU markets, 2009 Figure 61: Age distribution of childhood and adult acute lymphoblastic leukemia (ALL) in the seven major markets, 2009 Figure 62: Average treatment rates for adult acute lymphoblastic leukemia (ALL) patients in the seven major pharmaceutical markets, 2009 Figure 63: Top three chemotherapy regimens used in the induction therapy of adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Figure 64: Top three chemotherapy regimens used in the consolidation therapy of standard-risk adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Figure 65: Top three chemotherapy regimens used in the consolidation therapy of high-risk adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Figure 66: Top three chemotherapy regimens used in the maintenance therapy of standard-risk adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Figure 67: Top three chemotherapy regimens used in the maintenance therapy of high-risk adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Figure 68: Average use of clinical trials in the induction, consolidation, and maintenance therapy of adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Figure 69: Average use of hematopoietic stem cell transplantation in the consolidation and maintenance therapy of adult acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2009 Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

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