Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth

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Pipeline Insight: Leukemias Underserved patient populations offer
potential for market growth
Published on March 2010

Report Summary

Introduction

Despite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmet
needs. Some key oncology companies have entered the leukemias market fairly recently while others are pursuing late-phase
development in this indication, hoping to exploit the commercial potential of patient subgroups underserved by existing treatment
options.

Scope

*Forecast sales of the drugs in late-phase development for leukemia in the seven major markets over the period 2010 to 2019

*In-depth analysis for all leukemia drugs in late-phase development, including trial data, SWOT analysis and clinical and commercial
potential

*Segmentation and analysis of the leukemia pipeline by developmental phase, class and indication

*Insight and analysis of leukemia market potential including epidemiology, patient segmentation, unmet needs and target product
profiles

Highlights

Despite high cure rates in some forms of leukemia, certain groups of patients still have high unmet needs. Drug developers are
targeting increasingly defined subsets of patients with high unmet need in order to establish a market for their products. Examples
include elderly patients and patients with certain genetic characteristics.

Chronic lymphocytic leukemia (CLL) offers the greatest potential. Datamonitor forecasts the three drugs in late-phase development to
achieve total sales of $938m in 2019. This stems from the large size of the target patient populations and a lack of effective treatment
options in these patient subgroups, which will drive high market penetration.

A number of late-phase drugs will have a notable impact on the leukemia market as they go some way towards addressing some of
the remaining unmet needs. These agents include Revlimid (lenalidomide; Celgene), RG7159 (obinutuzumab;
Glycart/Roche/Genentech/Biogen Idec/Chugai) and bosutinib (PF-5208763; Pfizer).

Reasons to Purchase

*Justify go/no-go decisions on the basis of potential return on investment

*Identifying licensing opportunities based on company portfolio and market needs

Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 1/15


*Use product profiles to aid pricing and reimbursement decisions

Table of Content

Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Oncology pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Contributing experts 5
Related reports 5
Upcoming related reports 5
TABLE OF CONTENTS 6
1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Pipeline summary 8
Acute myeloid leukemia is the form of leukemia most targeted by drug developers 9
Targeted therapies account for over half of leukemia drugs in clinical development 11
Comparative forecasts 12
Drugs in late-phase development for leukemias will achieve combined sales of $1.9 billion by 2019 12
Key companies involved in the leukemias pipeline 14
Novartis 14
Roche 15
Key R&D company strategies 16
Drug developers are targeting increasingly defined subsets of patients 16
2. R&D Approach 17
Key findings 17
Clinical trial design in leukemia 17
Patient selection 17
Increasingly significant in the era of targeted treatment 17
Clinical trial duration 18
Sufficient follow-up is necessary to establish true clinical benefit 18
The advent of novel therapies 18
Diversity of targeted therapies will require an evolution in clinical trial design 18
Clinical trial endpoints in leukemia 18
Most oncology clinical trials designate multiple endpoints 18
Survival 19
Quality of life 19
Response rates 19
Toxicity 19
Time to progression 19
3. Acute lymphoblastic leukemia 21
Key findings 21



Disease overview - market potential 22
Definition of acute lymphoblastic leukemia (ALL) 22
ALL is a group of disorders that result from aberrant proliferation and differentiation of lymphoblasts 22
Genetic alterations provide insight into the pathogenesis of ALL 22
Non-specific syndromes are common in ALL 23
Patient segmentation 23
The classification of ALL is still evolving 23
Patients are stratified according to risk 24
Response to therapy: minimal residual disease is a critical prognostic factor 25
Epidemiology 25
Incidence of ALL will reach over 11,000 in the seven major markets by 2019 25
Current treatment options 27
Remission-induction 31
Consolidation treatment 32
Maintenance treatment 32
Current comparator therapies 33
Unmet need in ALL 33
More effective therapies are required for adult ALL, particularly for relapse 33
Philadelphia chromosome-positive patients remain a patient subset with high unmet need despite new therapies 34
More research is needed for elderly ALL patients 34
Prognostic markers are required for risk-adapted therapeutic strategies 35
Target product profiles versus current level of attainment 35
Induction therapy 35
Relapse therapy 36
Pipeline analysis and forecasts 38
Pipeline summary 38
Graspa (erythrocyte-encapsulated L-asparaginase; ERYtech) 42
Drug overview 42
Drug profile 42
Key historical events 43
Clinical trial data 43
Phase II data suggest that Graspa is better tolerated than native L-asparaginase, while inducing similar asparagine depletion 44
SWOT analysis 45
Clinical and commercial attractiveness 45
Limited evidence of clinical efficacy makes it difficult to comment on Graspa's clinical potential 45
A favorable toxicity profile alone may not be sufficient for Graspa to capture significant market share 45
Forecasts to 2019 46
Marqibo (liposomal vincristine; Hana Biosciences) 47
Drug overview 47
Drug profile 47
Marqibo shows promising evidence of efficacy in heavily pretreated ALL 50
SWOT analysis 52
Datamonitor's drug assessment summary for Marqibo 53
Marqibo will only partially address the need for more effective salvage regimens in ALL 53
Data from a small single-arm study may be insufficient to support approval and drive uptake of Marqibo 54



Rituxan/MabThera (rituximab; Biogen Idec/Roche/Genentech/Zenyaku Kogyo/Chugai) 55
Drug overview 55
Drug profile 56
Rituxan/MabThera plus HyperCVAD shows promising evidence of efficacy in younger patients with CD20-positive ALL 58
Rituxan/MabThera plus HyperCVAD also shows promising efficacy in Burkitt-type ALL, particularly in elderly patients 59
SWOT analysis 61
Datamonitor drug assessment summary for Rituxan 62
Phase II data point to Rituxan/MabThera's promising potential in ALL, but provoke several questions 62
The use of Rituxan/MabThera in ALL may remain off-label for the foreseeable future 63
4. Acute myeloid leukemia 65
Key findings 65
Definition of acute myeloid leukemia (AML) 66
AML is a disease of older age 66
Symptoms can vary for AML patients 66
Two classification systems are used in AML 66
Cytogenetics is the most important prognostic factor 67
Age is a major determinant of survival 68
Secondary AML patients have particularly poor prognosis 69
Epidemiology 69
Incidence of AML will reach over 31,000 in the seven major markets by 2019, driven by population aging 69
Induction treatment 73
Post-induction treatment 73
Consolidation treatment 74
Relapse treatment 74
Current comparator therapies 74
Unmet need in AML 75
More effective and tolerable therapies are required for AML, particularly in older patients 75
HSCT remains an underutilized procedure 76
Molecular markers may help improve risk-adapted therapeutic strategies 76
Induction therapy 77
Consolidation therapy 77
Relapse therapy 78
Pipeline summary 80
AS1413 (amonafide; Antisoma) 85
Drug overview 85
Drug profile 85
Antisoma has amended the primary endpoint in AS1413's pivotal Phase III study 87
Phase II study shows encouraging evidence of activity in secondary AML 88



SWOT analysis 89
Datamonitor drug assessment summary for AS1413 90
AS1413 has the potential to address unmet need in a difficult-to-treat patient population 90
AS1413's potential in the wider AML population is uncertain 91
Clolar/Evoltra (clofarabine; Genzyme) 92
Drug overview 92
Drug profile 93
Phase II data in newly diagnosed elderly AML insufficient to support label extension for Clolar 97
Phase II data show potential of Clolar in combination with low-dose cytarabine 98
SWOT analysis 99
Datamonitor drug assessment summary for Clolar/Evoltra 100
Clolar's unsuccessful bid for accelerated approval in AML is a double blow to Genzyme 100
Clolar could receive off-label use in the absence of label expansion 101
Dacogen (decitabine; Eisai) 103
Drug overview 103
Drug profile 104
Dacogen has shown promising evidence of efficacy in previously untreated elderly AML patients 107
SWOT analysis 109
Datamonitor drug assessment summary for Dacogen 110
Dacogen's low toxicity could be a major driver of uptake 110
Vidaza will be Dacogen's principal competitor in the AML market 111
Midostaurin (PKC412; Novartis) 113
Drug overview 113
Drug profile 113
Midostaurin shows promising evidence of efficacy in AML patients with wild-type and mutant Flt-3 116
SWOT analysis 117
Datamonitor drug assessment summary for midostaurin 118
Targeting younger AML patients offers lower commercial potential for midostaurin 118
Novartis's capabilities in niche hematological indications will boost midostaurin's commercial potential 119
PR1 peptide antigen vaccine (The Vaccine Company) 121
Drug overview 121
Drug profile 122
PR1 peptide antigen induced immune and clinical responses in patients with myeloid hematological malignancies in Phase I/II trial
124



SWOT analysis 125
Datamonitor drug assessment summary for PR1 peptide antigen 126
PR1 peptide antigen could fulfill the unmet need for more tolerable treatment options in elderly AML patients 126
As a therapeutic vaccine, PR-1 peptide antigen will face particular barriers to successful commercialization 127
5. Chronic lymphocytic leukemia 128
Key findings 128
Definition of chronic lymphocytic leukemia (CLL) 129
CLL is an incurable disease characterized by an accumulation of mature B-lymphocytes 129
The definition of CLL has recently changed 130
The etiology of CLL is poorly understood 130
Rai and Binet staging systems are used to stage CLL 131
Molecular markers are used to identify high-risk patients 132
Epidemiology 133
CLL will remain the most commonly diagnosed leukemia in the seven major markets through to 2019 133
Physicians commonly initiate first-line treatment after a period of observation 137
First-line treatment 138
Second- and third-line treatment 138
Current comparator therapy 138
Rituxan/MabThera (rituximab; Biogen Idec/Genentech/Roche/Chugai/Zenyaku Kogyo) 138
Unmet need in CLL 140
More effective therapies are needed for relapsed and refractory CLL 140
CLL still lacks curative treatment options for the majority of patients 141
More tolerable treatment options are needed for elderly patients 141
First-line therapy 142
Second-line therapy 143
Pipeline summary 144
Alvocidib (flavopiridol; Sanofi-Aventis) 148
Drug overview 148
Drug profile 148
Optimization of alvocidib's dosing schedule has reawakened interest in the drug 150
Single-agent alvocidib induces responses in heavily pretreated CLL patients with unfavorable cytogenetics 150
Alvocidib has also shown promise in early stages studies in combination with fludarabine and Rituxan 152
SWOT analysis 153
Datamonitor drug assessment summary for alvocidib 154
Alvocidib has shown encouraging signs of activity in difficult-to-treat patients 154
Sanofi-Aventis will have to overturn negative perceptions of alvocidib's clinical development in CLL 155
Arzerra could prove to be a major competitor for alvocidib, given its more favorable toxicity profile 155
Revlimid (lenalidomide; Celgene) 157



Drug overview 157
Drug profile 158
Celgene has initiated an extensive clinical development program for Revlimid in CLL 160
Low dose single-agent Revlimid shows promising activity and tolerability in heavily pretreated CLL 161
Early Phase II data show that single-agent Revlimid has favorable toxicity profile in previously untreated elderly CLL 162
Revlimid may be more effective when combined with Rituxan 163
SWOT analysis 164
Datamonitor drug assessment summary for Revlimid 165
Revlimid has the potential to fill a niche in the CLL market 165
Revlimid's favorable toxicity profile could be an important attribute in the maintenance setting 166
Potential for long-term use could boost Revlimid's commercial potential in CLL 167
RG7159 (obinutuzumab; Glycart/Roche/Genentech/Biogen Idec/Chugai) 169
Drug overview 169
Drug profile 170
There is currently minimal reported evidence of RG7159's clinical efficacy 172
SWOT analysis 173
Datamonitor drug assessment summary for RG7159 174
Roche has avoided the risk of cannibalizing Rituxan's market share in CLL 174
The design of RG7159's pivotal trial is high-risk, but necessary in order to drive notable uptake 175
6. Chronic myeloid leukemia 177
Key findings 177
Definition of chronic myeloid leukemia (CML) 178
CML is characterized by a single genetic aberration 178
CML patients are commonly asymptomatic at presentation 178
CML has an unknown etiology 178
CML has a triphasic or biphasic disease course 179
Epidemiology 181
Annual CML incidence will rise to nearly 13,000 in the seven major markets by 2019 181
Improving treatment outcomes will drive significant increases in the prevalence of CML 183
The market potential for newly-diagnosed CML will grow markedly between 2010 and 2019 186
Small molecule Bcr-Abl tyrosine kinase inhibitors dominate the treatment of CML 187
Treatment of newly-diagnosed CML 188
Gleevec-refractory CML 188
Current comparator therapy 188
Gleevec/Glivec (imatinib; Novartis) 188
Unmet need in CML 190
Resistance to Bcr-Abl tyrosine kinase inhibitors is an area of high unmet need 190
Blast crisis lacks effective treatment options but is not a commercially attractive indication 192
Despite good treatment outcomes for the majority of chronic phase patients, there is room for improvement 192



Newly diagnosed CML 192
Gleevec refractory/intolerant CML 193
Pipeline summary 195
Bosutinib (PF-5208763; Pfizer) 199
Drug overview 199
Drug profile 200
Bosutinib has shown promising activity and a favorable toxicity profile in Gleevec-resistant/intolerant CML 202
SWOT analysis 204
Datamonitor drug assessment summary for bosutinib 205
Bosutinib could struggle to penetrate a crowded first-line market ... 205
...although its promising safety profile could allow Pfizer to position it effectively in the CML market 206
Omapro (omacetaxine mepesuccinate; ChemGenex/Hospira) 209
Drug overview 209
Drug profile 210
Omapro shows promising activity in Gleevec-resistant patients with the T315I mutation but ODAC vote could delay approval 213
Omapro also shows activity in patients refractory/intolerant to at least two tyrosine kinase inhibitors 214
SWOT analysis 215
Datamonitor drug assessment summary for Omapro 216
Omapro may address one of the largest remaining areas of unmet in CML in the Gleevec era 216
Prospects of approval remain uncertain for Omapro 217
Advances in first-line therapy could threaten Omapro's commercial potential 217
Bibliography 219
Journals 219
Websites 229
Datamonitor reports 232
Other 232
APPENDIX 233
Methodology 233
Datamonitor forecast methodology 233
Epidemiology forecasts 233
Product forecasts 233
Datamonitor drug assessment scorecard 234
Contributing experts 235
About Datamonitor 235
About Datamonitor Healthcare 235
About the Disease analysis team 236
Datamonitor consulting 236
Disclaimer 238
List of Tables



Table 1: Drugs in late-phase clinical development for leukemia in the seven major pharmaceutical markets, 2010 9
Table 2: Sales forecasts for drugs in late-phase clinical development for leukemia across the seven major markets, 2010-19 ($m) 12
Table 3: Novartis's portfolio of marketed and pipeline leukemia drugs, 2010 14
Table 4: Roche's portfolio or marketed and pipeline leukemia drugs, 2010 15
Table 5: The French-American-British system for the classification of acute lymphoblastic leukemia (ALL) 23
Table 6: Crude incidence rates of acute lymphoblastic leukemia (ALL) per 100,000 population in the seven major pharmaceutical
markets, 2002 26
Table 7: Forecast incidence of acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2002-2019 26
Table 8: Leading agents for acute lymphocytic leukemia (ALL), 2010 29
Table 9: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute
lymphoblastic leukemia (ALL), 2010 36
Table 10: Minimum acceptable product profile (MAPP) and target product profile (TPP) for the treatment of relapsed adult acute
lymphoblastic leukemia (ALL), 2010 37
Table 11: Drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL), 2010 38
Table 12: Forecast assumptions for drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL) across the seven
major markets, 2010 40
Table 13: Sales forecasts for drugs in late-phase clinical development for acute lymphoblastic leukemia across the seven major
markets, 2010-19 ($m) 41
Table 14: Graspa - drug profile, 2010 42
Table 15: Graspa: key historical events, 2004-2010 43
Table 16: Clinical development of Graspa in acute lymphoblastic leukemia (ALL), 2010 43
Table 17: Marqibo - drug profile, 2010 47
Table 18: Marqibo: key historical events, 2000-2010 48
Table 19: Clinical development of Marqibo in acute lymphoblastic leukemia (ALL), 2010 49
Table 20: Sales forecast for Marqibo in acute lymphoblastic leukemia (ALL) across the seven major markets, 2010-19 ($m) 54
Table 21: Rituxan/MabThera - drug profile, 2010 56
Table 22: Rituxan/MabThera: key historical events, 1997-2010 57
Table 23: Clinical development of Rituxan/MabThera in acute lymphoblastic leukemia (ALL), 2010 58
Table 24: Sales forecast for Rituxan in acute lymphoblastic leukemia (ALL) across the seven major markets, 2010-19 ($m) 64
Table 25: French-American-British classification of acute myeloid leukemia (AML) 67
Table 26: Crude incidence rates of acute myeloid leukemia (AML) per 100,000 population in the seven major pharmaceutical markets,
2002 69
Table 27: Forecast incidence of acute myeloid leukemia (AML) in the seven major pharmaceutical markets, 2002-2019 70
Table 28: Leading agents for acute myeloid leukemia (AML), 2010 72
Table 29: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute myeloid
leukemia (AML), 2010 77
Table 30: Minimum acceptable product profile (MAPP) and target product profile (TPP) for consolidation treatment of adult acute
myeloid leukemia (AML) in first remission, 2010 78
Table 31: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute myeloid
leukemia (AML), 2010 79
Table 32: Drugs in late-phase clinical development for acute myeloid leukemia (AML), 2010 80
Table 33: Forecast assumptions for drugs in late-phase clinical development for acute myeloid leukemia (AML) across the seven
major markets, 2010 (1 of 2) 82
Table 34: Forecast assumptions for drugs in late-phase clinical development for acute myeloid leukemia (AML) across the seven
major markets, 2010 (2 of 2) 83
Table 35: Sales forecasts for drugs in late-phase clinical development for acute myeloid leukemia across the seven major markets,
2010-19 ($m) 84
Table 36: AS1413 - drug profile, 2010 85
Table 37: AS1413: key historical events, 2003-2010 86
Table 38: Clinical development of AS1413 in acute myeloid leukemia, 2010 87



Table 39: Sales forecast for AS1413 in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 91
Table 40: Clolar/Evoltra - drug profile, 2010 93
Table 41: Clolar/Evoltra: key historical events, 1998-2010 94
Table 42: Clinical development of Clolar/Evoltra in acute myeloid leukemia (AML), 2010 95
Table 43: Sales forecast for Clolar/Evoltra in acute myeloid leukemia across the seven major markets, 2010-19 ($m) 102
Table 44: Dacogen - drug profile, 2010 104
Table 45: Dacogen: key historical events, 1999-2010 105
Table 46: Clinical development of Dacogen in acute myeloid leukemia (AML), 2010 106
Table 47: Sales forecast for Dacogen in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 112
Table 48: Midostaurin - drug profile, 2010 113
Table 49: Midostaurin: key historical events, 2002-2010 114
Table 50: Clinical development of midostaurin in acute myeloid leukemia (AML), 2010 115
Table 51: Sales forecast for midostaurin in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 120
Table 52: PR1 peptide antigen - drug profile, 2010 122
Table 53: PR1 peptide antigen: key historical events, 1999-2010 122
Table 54: Clinical development of PR1 peptide antigen, 2010 123
Table 55: Sales forecast for PR1 peptide antigen vaccine in acute myeloid leukemia (AML) across the seven major markets, 2010-19
($m) 127
Table 56: The Rai staging system for chronic lymphocytic leukemia (CLL) 131
Table 57: The Binet staging system for chronic lymphocytic leukemia (CLL) 131
Table 58: Crude incidence rates of chronic lymphocytic leukemia (CLL) per 100,000 population in the seven major pharmaceutical
markets, 2002 133
Table 59: Forecast incidence of chronic lymphocytic leukemia (CLL) in the seven major pharmaceutical markets, 2002-2019 134
Table 60: Leading agents for chronic lymphocytic leukemia (CLL), 2010 136
Table 61: Rituxan/MabThera (rituximab) - drug profile, 2010 139
Table 62: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of chronic lymphocytic
leukemia (CLL), 2010 142
Table 63: Minimum acceptable product profile (MAPP) and target product profile (TPP) for second-line treatment of chronic
lymphocytic leukemia (CLL), 2010 143
Table 64: Drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL), 2010 144
Table 65: Forecast assumptions for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL) across the seven
Table 66: Sales forecasts for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL) across the seven major
markets, 2010-19 ($m) 147
Table 67: Alvocidib - drug profile, 2010 148
Table 68: Alvocidib: key historical events, 2004-2010 149
Table 69: Clinical development of alvocidib in chronic lymphocytic leukemia (CLL), 2010 150
Table 70: Phase I dose-escalating study of alvocidib in combination with chemotherapy in patients with indolent B-cell non-Hodgkin's
lymphoma, chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) 152
Table 71: Sales forecast for alvocidib in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 156
Table 72: Revlimid - drug profile, 2010 158
Table 73: Revlimid: key historical events, 2005-2010 159
Table 74: Clinical development of Revlimid in chronic lymphocytic leukemia (CLL), 2010 160
Table 75: Sales forecast for Revlimid in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 168
Table 76: RG7159 - drug profile, 2010 170
Table 77: RG7159: key historical events, 2007-2010 171
Table 78: Clinical development of RG7159 in chronic lymphocytic leukemia (CLL), 2010 172
Table 79: Sales forecast for RG7159 in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 176
Table 80: Different definitions of accelerated phase chronic myeloid leukemia (AP-CML), 2010 179
Table 81: Different definitions of blast crisis chronic myeloid leukemia (BC-CML) 180



Table 82: Crude incidence rates of chronic myeloid leukemia (CML) per 100,000 population in the seven major pharmaceutical
markets, 2002 181
Table 83: Forecast incidence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2002-2019 182
Table 84: Forecast prevalence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 184
Table 85: Number of chronic phase chronic myeloid leukemia (CP-CML) patients in first complete cytogenetic remission (CCyR)
receiving a tyrosine kinase inhibitor in the seven major markets, 2010-19 186
Table 86: Leading agents for chronic myeloid leukemia (CML), 2010 187
Table 87: Gleevec (imatinib; Novartis) - drug profile, 2010 189
Table 88: Number of chronic myeloid leukemia (CML) patients developing Gleevec resistance in the seven major pharmaceutical
markets, 2010-19 191
Table 89: Minimum acceptable product profile (MAPP) and target product profile (TPP) for treatment of newly diagnosed chronic
phase chronic myeloid leukemia (CP-CML), 2010 193
Table 90: Minimum acceptable product profile (MAPP) and target product profile (TPP) treatment of Gleevec-refractory/intolerant
chronic phase chronic myeloid leukemia (CP-CML), 2010 194
Table 91: Drugs in late-phase clinical development for chronic myeloid leukemia (CML), 2010 195
Table 92: Forecast assumptions for drugs in late-phase clinical development for chronic myeloid leukemia (CML) across the seven
Table 93: Sales forecasts for drugs in late-phase clinical development for chronic myeloid leukemia (CML) across the seven major
markets, 2010-19 ($m) 198
Table 94: Bosutinib - drug profile, 2010 200
Table 95: Bosutinib: key historical events, 2006-2010 201
Table 96: Clinical development of bosutinib in chronic myeloid leukemia (CML), 2010 201
Table 97: Sales forecast for bosutinib in chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 208
Table 98: Omapro - drug profile, 2010 210
Table 99: Omapro: key historical events, 2004-2010 211
Table 100: Clinical development of Omapro in chronic myeloid leukemia (CML), 2010 212
Table 101: Sales forecast for Omapro in chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 218
Table 102: Datamonitor drug assessment parameters 234
List of Figures
Figure 1: Number of drugs in clinical development for the four principal subtypes of leukemia, by phase of development, 2010 10
Figure 2: Number of drugs in clinical development for leukemia, by phase of development and class, 2010 11
Figure 3: Forecast incidence of acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2010-19 27
Figure 4: Summary of unmet needs in acute lymphoblastic leukemia (ALL), 2010 33
Figure 5: Datamonitor drug assessment for drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL), 2010 39
Figure 6: Summary of data from GRASPALL Phase II study of Graspa in relapsed acute lymphoblastic leukemia (ALL) 44
Figure 7: Graspa - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 45
Figure 8: Summary of data from rALLy Phase II study of Marqibo in relapsed acute lymphoblastic leukemia (ALL) 50
Figure 9: Summary of data from Phase I/II study of Marqibo in relapsed/refractory acute lymphoblastic leukemia (ALL) 51
Figure 10: Marqibo - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 52
Figure 11: Datamonitor drug assessment summary for Marqibo in acute lymphoblastic leukemia (ALL), 2010 53
Figure 12: Summary of data from Phase II study of Rituxan/MabThera in newly-diagnosed Philadelphia chromosome-negative,
CD20-positive precursor B-cell acute lymphoblastic leukemia (ALL) 59
Figure 13: Summary of data from Phase II study of Rituxan/MabThera in newly-diagnosed Burkitt-type acute lymphoblastic leukemia
(ALL)/Burkitt lymphoma 60
Figure 14: Rituxan/MabThera - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 61
Figure 15: Datamonitor drug assessment summary for Rituxan in acute lymphoblastic leukemia (ALL), 2010 62
Figure 16: Forecast incidence of acute myeloid leukemia (AML) in the seven major pharmaceutical markets, 2010-19 71
Figure 17: Summary of unmet needs in acute myeloid leukemia (AML), 2010 75
Figure 18: Datamonitor drug assessment for drugs in late-phase clinical development for acute myeloid leukemia (AML), 2010 81
Figure 19: Summary of data from Phase II study of AS1413 in secondary acute myeloid leukemia (AML) 88



Figure 20: AS1413 - SWOT analysis in acute myeloid leukemia (AML), 2010 89
Figure 21: Datamonitor drug assessment summary for AS1413 in acute myeloid leukemia (AML), 2010 90
Figure 22: Summary of preliminary data from the 'CLASSIC II' Phase II study of Clolar/Evoltra in newly-diagnosed elderly acute
myeloid leukemia (AML) patients 97
Figure 23: Summary of preliminary data from a Phase II study of Clolar/Evoltra in combination with low-dose cytarabine in
newly-diagnosed elderly acute myeloid leukemia (AML) patients 98
Figure 24: Clolar/Evoltra - SWOT analysis in acute myeloid leukemia (AML), 2010 99
Figure 25: Datamonitor drug assessment summary for Clolar/Evoltra in acute myeloid leukemia (AML), 2010 100
Figure 26: Summary of data from Phase II trial of Dacogen in previously untreated elderly acute myeloid leukemia (AML) patients 107
Figure 27: Summary of data from a multicenter Phase II trial of Dacogen in previously untreated elderly acute myeloid leukemia (AML)
patients 108
Figure 28: Dacogen - SWOT analysis in acute myeloid leukemia (AML), 2010 109
Figure 29: Datamonitor drug assessment summary for Dacogen in acute myeloid leukemia (AML), 2010 110
Figure 30: Summary of data from Phase Ib study of midostaurin in newly-diagnosed acute myeloid leukemia (AML) 116
Figure 31: Midostaurin - SWOT analysis in acute myeloid leukemia (AML), 2010 117
Figure 32: Datamonitor drug assessment summary for midostaurin in acute myeloid leukemia (AML), 2010 118
Figure 33: Phase I/II trial results investigating PR1 peptide antigen in mixed myeloid hematological malignancies 124
Figure 34: PR1 peptide antigen - SWOT analysis in acute myeloid leukemia (AML), 2010 125
Figure 35: Datamonitor drug assessment summary for PR1 peptide antigen in acute myeloid leukemia (AML), 2010 126
Figure 36: Characteristic immunophenotype of accumulating malignant B-lymphocytes in chronic lymphocytic leukemia (CLL) 129
Figure 37: Forecast incidence of chronic lymphocytic leukemia (CLL) in the seven major pharmaceutical markets, 2010-19 135
Figure 38: Summary of unmet needs in chronic lymphocytic leukemia (CLL), 2010 140
Figure 39: Datamonitor drug assessment for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL), 2010
145
Figure 40: Summary of data from Phase II clinical trial of alvocidib in relapsed/refractory chronic lymphocytic leukemia (CLL) 151
Figure 41: Alvocidib - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 153
Figure 42: Datamonitor drug assessment summary for alvocidib in chronic lymphocytic leukemia (CLL), 2010 154
Figure 43: Phase II study of Revlimid in relapsed/refractory chronic lymphocytic leukemia (CLL), 161
Figure 44: Preliminary data from Phase II study of Revlimid as first-line treatment in elderly chronic lymphocytic leukemia (CLL)
patients 162
Figure 45: Preliminary data from Phase II trial of Revlimid plus Rituxan in relapsed/refractory chronic lymphocytic leukemia (CLL) 163
Figure 46: Revlimid - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 164
Figure 47: Datamonitor drug assessment summary for Revlimid in chronic lymphocytic leukemia (CLL), 2010 165
Figure 48: RG7159 - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 173
Figure 49: Datamonitor drug assessment summary for RG7159 in chronic lymphocytic leukemia (CLL), 2010 174
Figure 50: Forecast incidence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 183
Figure 51: Forecast prevalence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 185
Figure 52: Summary of unmet needs in chronic lymphocytic leukemia (CML), 2010 190
Figure 53: Datamonitor drug assessment for drugs in late-phase clinical development for chronic myeloid leukemia (CML), 2010 196
Figure 54: Phase II study of bosutinib in Gleevec-resistant/intolerant chronic myeloid leukemia (CML) in chronic phase 202
Figure 55: Phase II study of bosutinib in Gleevec-resistant/intolerant chronic myeloid leukemia (CML) in accelerated phase or blast
crisis 203
Figure 56: Bosutinib - SWOT analysis in chronic myeloid leukemia (CML), 2010 204
Figure 57: Datamonitor drug assessment summary for bosutinib in chronic myeloid leukemia (CML), 2010 205
Figure 58: Study 202: Interim data from Phase II/III study of Omapro in Gleevec-resistant chronic myeloid leukemia (CML) patients
with the T315I mutation 213
Figure 59: Study 203: Interim data from Phase II/III study of Omapro in chronic myeloid leukemia (CML) patients resistant/intolerant to
at least two tyrosine kinase inhibitors 214
Figure 60: Omapro - SWOT analysis in chronic myeloid leukemia (CML), 2010 215
Figure 61: Datamonitor drug assessment summary for Omapro in chronic myeloid leukemia (CML), 2010 216



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