Pipeline Insight: Hematological Malignancies - Pursuit for the next blockbuster intensifies
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the hematological malignancies market - page 4
- Key metrics - page 6
- Datamonitor pipeline assessment summary - page 10
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS - page 24
- Pipeline overview - page 24
- Products in late-phase development for hematological malignancies - page 24
- Products in Phase II development for hematological malignancies - page 27
- Products in Phase I development for hematological malignancies - page 36
- Pipeline by developmental phase and class - page 43
- There are 180 different products in the clinical developmental pipeline for hematological malignancies - page 43
- Segmentation of products by developmental phase reflects high attrition rate in oncology drug development - page 44
- Segmentation of products by class reflects shift in oncology drug development away from cytotoxics - page 49
- There are 180 different products in the clinical developmental pipeline for hematological malignancies - page 43
- Pipeline by indication - page 52
- Over 50% of the pipeline products are being investigated in leukemia - page 52
- The 22 late-phase pipeline products target eight different hematological malignancies - page 55
- Pipeline by company - page 57
- Developmental pipeline dominated by small pharma/biotech players - page 57
- Only 17 (12%) companies/institutes have more than two candidates in the developmental pipeline for hematological malignancies - page 58
- Novartis has six candidates in clinical development - page 59
- Biogen Idec draws on the success of Rituxan - page 61
- Pipeline overview - page 24
- CHAPTER 3 HEMATOLOGICAL MALIGNANCIES - MARKET POTENTIAL - page 64
- A diverse range of disease subtypes - page 64
- Genetic basis of cancer evolution - page 64
- Tumorigenesis is the result of co-operative accumulated mutations - page 66
- Existing pharmacotherapy approaches provide limited treatment benefit - page 66
- Cytotoxic drugs lack specificity - page 67
- Hormonal or endocrine therapy provides incremental benefit in selected tumors - page 67
- Optimizing current treatment strategies is paramount - page 67
- The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy - page 67
- Dynamic cancer market offers significant commercial opportunity - page 68
- Ongoing sales growth drives the market - page 68
- Intensive R&D produces a rich developmental pipeline - page 69
- Epidemiology - Hematological Malignancies - page 70
- Cancer epidemiology - an expanding patient base - page 70
- Leukemia - page 73
- Lymphoma - page 77
- Multiple myeloma - page 81
- Myelodysplastic syndrome - page 83
- Disproportionate increase in prevalence results from improvements in diagnosis and treatment - page 86
- Significant areas of unmet need persist - page 88
- The need for more sophisticated pharmacotherapy - page 88
- Long-term control of advanced tumors is suboptimal - page 88
- Novel strategies required to reduce relapse rates in early-stage disease - page 89
- Toxicity of existing treatments jeopardizes quality of life and rates of treatment uptake - page 89
- Improvements in diagnostics and prognostic analysis will enhance cost-effectiveness of treatment - page 90
- Enhanced preventative strategies will ease the disease burden - page 90
- Clinical and strategic threats to the commercialization of cancer drugs - page 91
- Progressively rising R&D costs threaten industry productivity - page 91
- High attrition rates can be mitigated by improved strategic decision-making - page 92
- Lengthening drug approval process - a consequence of increased regulatory demands - page 92
- Pharmacoeconomic pressures drive payers to implement restrictive pricing and reimbursement policies - page 92
- Therapeutic and generic competition reduces periods of market exclusivity - page 93
- Segmentation of market will require changes in clinical trial methodology - page 94
- Progressively rising R&D costs threaten industry productivity - page 91
- CHAPTER 4 R&D APPROACH - page 95
- Classification of pipeline products - page 95
- Molecular targeted therapies - page 95
- Angiogenesis inhibitors - page 95
- Single-target signal transduction inhibitors - page 99
- Multi-targeted inhibitors - page 99
- Cell cycle and apoptosis targeted inhibitors - page 101
- Epigenetic modulators - page 103
- Cytotoxic Therapies - page 104
- Antimetabolites - page 104
- Mitotic inhibitors - page 105
- DNA-interactive chemotherapeutic agents - page 105
- Immunotherapeutic agents - page 110
- Antibody-based technologies are an effective anticancer approach - page 110
- Active, specific immunotherapy - page 111
- Molecular targeted therapies - page 95
- Evolution in oncology clinical trial design - page 112
- Patient selection is increasingly significant in the era of targeted treatment - page 113
- Clinical trials must have sufficient follow-up to establish true clinical benefit - page 114
- Diversity of targeted treatments will require an evolution in clinical trial design - page 114
- Most oncology clinical trials designate multiple endpoints - page 115
- Survival - page 115
- Quality of life - page 115
- Tumor response rates - page 116
- Toxicity - page 116
- Time to tumor progression - page 116
- Modification of accelerated approval process may impact significantly on approval times for hematologic oncology drugs - page 117
- Classification of pipeline products - page 95
- CHAPTER 5 MOLECULAR TARGETED THERAPIES ANALYSIS AND FORECASTS - page 120
- Overview of molecular targeted therapies for hematological malignancies - page 120
- Pipeline summary - page 120
- Late-phase pipeline of molecular targeted therapies - page 121
- Phase II pipeline of molecular targeted therapies - page 122
- Phase I pipeline of molecular targeted therapies - page 125
- Comparative forecasts - page 127
- Definition of current comparator therapy - page 130
- Novartis's Gleevec/Glivec (imatinib) - page 130
- Pipeline summary - page 120
- Tasigna (Nilotinib, AMN-107; Novartis) - page 133
- Drug overview - page 133
- Clinical trial data - page 133
- Tasigna enters preregistration in the US and EU for Gleevec-resistant CML - page 133
- Promising Phase II interim data reported - page 134
- Tasigna appears effective in CML patients who have failed or are intolerant to both Gleevec and Sprycel - page 138
- Only one BCR-ABL mutation is insensitive to Tasigna - page 139
- Datamonitor comments - page 140
- Tasigna ready to challenge Bristol-Myers Squibb's already approved Sprycel - page 140
- Novartis looking to expand its leading role in the CML therapy market - page 140
- Forecasts to 2016 - page 141
- Datamonitor drug assessment summary - page 142
- Ceflatonin (Myelostat; ChemGenex Pharmaceuticals) - page 143
- Drug overview - page 143
- Clinical trial data - page 144
- Ceflatonin receives Fast Track status for chronic myeloid leukemia - page 145
- Ceflatonin aims to restore Gleevec sensitivity in CML patients - page 145
- ChemGenex looking to expand Ceflatonin into the AML/APL market - page 147
- Datamonitor comments - page 148
- Despite convincing clinical benefit, Ceflatonin will face strong competition from Bristol-Myers Squibb's Sprycel and Novartis's Tasigna - page 148
- Forecasts to 2016 - page 149
- Datamonitor drug assessment summary - page 150
- Sarasar (Lonafarnib; Schering-Plough) - page 151
- Drug overview - page 151
- Clinical trial data - page 152
- Main focus of Sarasar development in MDS, where greatest antitumor activity is shown - page 152
- Farnesyl transferase inhibitors predominately in hematological disorders - page 153
- Mild toxicity in the majority of patients, although grade 3 events do occur - page 153
- Datamonitor comments - page 154
- Sarasar's chances for approval will be delayed beyond 2007 - page 154
- Sarasar racing against Johnson & Johnson's Zarnestra as the first farnesyl transferase inhibitor to reach the market - page 154
- Presence in oncology market will aid commercialization of Sarasar - page 155
- Forecasts to 2016 - page 155
- Datamonitor drug assessment summary - page 157
- Torisel (Temsirolimus; Wyeth) - page 158
- Drug overview - page 158
- Torisel inhibits a key pathway in tumor cell proliferation - page 158
- Clinical trial data - page 159
- Torisel showing promise in mantle cell lymphoma - page 159
- Torisel also making headway in other NHL subtypes - page 161
- Datamonitor comments - page 163
- Torisel will have to face Velcade in the MCL market - page 163
- Prior commercialization of Mylotarg and Neumega will provide Wyeth with valuable insight into the oncology market - page 164
- Forecasts to 2016 - page 164
- Datamonitor drug assessment summary - page 165
- Drug overview - page 158
- Zarnestra (Tipifarnib; Janssen/Johnson & Johnson) - page 166
- Drug overview - page 166
- Clinical trial data - page 167
- Following rejection of NDA, the FDA requires Phase III data for Zarnestra in AML before regulatory approval can be considered - page 168
- Results from Phase III studies have yet to be announced - page 168
- Zarnestra has demonstrated a favorable profile in a variety of Phase II studies - page 169
- Single-agent Zarnestra demonstrates antitumor activity in relapsed/refractory aggressive NHL - page 171
- Zarnestra holding promise in juvenile myelomonocytic leukemia - page 172
- Initiation of Phase II trials in large granular lymphocyte leukemia and multiple myeloma - page 173
- Mild toxicity is particularly significant since Zarnestra's main indication is for elderly AML patients where quality of life is a major issue - page 173
- Datamonitor comments - page 173
- Schering-Plough's Sarasar catching up with Zarnestra as the first farnesyl transferase inhibitor to reach the market - page 173
- Johnson & Johnson limiting Zarnestra's target population in the short term - page 174
- Johnson & Johnson's experience will be invaluable to Zarnestra - page 175
- Forecasts to 2016 - page 175
- Datamonitor drug assessment summary - page 177
- Alvocidib (Flavopiridol; Sanofi-Aventis) - page 178
- Drug overview - page 178
- Clinical trial data - page 179
- Continuous infusion dosing schedules fail to demonstrate clinical activity - page 180
- Modified dosing regimen drives further development in CLL - page 182
- Datamonitor comments - page 183
- Given alvocidib's checkered history, Sanofi-Aventis may face an uphill struggle communicating the drug's potential - page 183
- Alvocidib may show more promise as part of a combination regimen - page 183
- Presence in oncology field will aid commercialization of alvocidib - page 183
- Enzastaurin (LY317615; Eli Lilly) - page 184
- Drug overview - page 184
- Clinical trial data - page 184
- Enzastaurin looking to make its mark in the B-Cell Lymphoma market - page 185
- Enzastaurin holding promise as a maintenance therapy in mantle cell lymphoma - page 186
- Datamonitor comments - page 186
- Eli Lilly adopt a risky stragtegy for enzastaurin in DLBCL - page 186
- Termination of Phase III trial for enzastaurin in glioma may hamper its potential in other indications - page 187
- Forecasts to 2016 - page 188
- Datamonitor drug assessment summary - page 189
- Lestaurtinib (CEP-701; Cephalon) - page 190
- Drug overview - page 190
- Clinical trial data - page 191
- Lestaurtinib emerging as a promising agent for AML patients harboring Flt-3 activating mutations - page 191
- Datamonitor comments - page 193
- Lestaurtinib may be the first in its class to reach the market - page 193
- Cephalon's recent acquisition of Trisenox will provide invaluable experience of the leukemia market - page 194
- Forecasts to 2016 - page 194
- Datamonitor drug assessment summary - page 195
- Genasense (Oblimersen; Genta) - page 196
- Drug overview - page 196
- Clinical trial data - page 197
- FDA reject Genasense for use in combination with chemotherapy in CLL - page 197
- Early-phase benefits of Genasense in AML require confirmation in Phase III clinical trial - page 198
- Disappointing Phase III trial results in multiple myeloma means status of further development is unclear - page 199
- Promise shown in combination with Rituxan in NHL, but randomized trials have yet to be initiated - page 200
- Datamonitor comments - page 201
- Approval of Genasense is looking increasingly unlikely - page 201
- Termination of agreement with Sanofi-Aventis is a major setback for Genta - page 202
- Forecasts to 2016 - page 202
- Datamonitor drug assessment summary - page 204
- Overview of molecular targeted therapies for hematological malignancies - page 120
- CHAPTER 6 CYTOTOXIC THERAPIES ANALYSIS AND FORECASTS - page 206
- Overview of cytotoxic therapies for hematological malignancies - page 206
- Pipeline summary - page 206
- Late-phase pipeline of cytotoxic therapies - page 207
- Phase II pipeline of cytotoxic therapies - page 208
- Phase I pipeline of cytotoxic therapies - page 210
- Comparative forecasts - page 210
- Pipeline summary - page 206
- Clolar/Evoltra (Clofarabine; Genzyme/Bioenvision) - page 212
- Drug overview - page 212
- Clinical trial data - page 213
- FDA and EMEA approve Clolar for ALL but further data in AML are required - page 215
- Clolar and cytarabine appears to be an active and well tolerated regimen for elderly AML patients for which a Phase III trial has recently been initiated - page 215
- Single-agent Clolar may provide an important treatment option for AML patients with adverse cytogenetics who are unsuitable for standard chemotherapy - page 217
- Despite further data now required for approval, Clolar demonstrates activity in pediatric AML - page 219
- Datamonitor comments - page 220
- While approval in AML will significantly broaden Clolar's label, increased economic constraints on healthcare systems may restrict its uptake - page 220
- Forecasts to 2016 - page 222
- Datamonitor drug assessment summary - page 223
- Dacogen (decitabine; MGI Pharma) - page 224
- Drug overview - page 224
- Clinical trial data - page 225
- Elderly AML is an attractive indication for horizontal expansion of Dacogen - page 226
- Dacogen as a maintenance therapy in AML - page 226
- Dacogen plus Zolinza may be an effective combination - page 227
- Datamonitor comments - page 227
- Dacogen would fulfill a high unmet need in unfavorable risk AML - page 227
- Dacogen may face competition from Vidaza, another approved DNA demethylating agent in development for AML - page 228
- Dacogen will compete with Mylotarg in the relapsed elderly AML market - page 228
- Forecasts to 2016 - page 229
- Datamonitor drug assessment summary - page 230
- Cloretazine (VNP40101M; Vion Pharmaceuticals) - page 231
- Drug overview - page 231
- Clinical trial data - page 232
- Cloretazine will enjoy the advantages of Orphan Drug and Fast Track status for AML - page 232
- Cloretazine and cytarabine appears a feasible combination for second-line AML - page 233
- Single agent Cloretazine appears effective in elderly poor risk AML - page 234
- High-risk MDS patients may also benefit from Cloretazine monotherapy - page 235
- Cloretazine and Temodar in hematological malignancies appears to be a rational combination - page 236
- Vion discontinues Cloretazine development in CLL to focus on AML - page 237
- Datamonitor comments - page 237
- Given persistent high unmet needs and the lack of a gold-standard in relapsed/refractory AML, Cloretazine demonstrates promise - page 237
- Vion should seek a collaborative agreement with a more experienced oncology partner - page 238
- Forecasts to 2016 - page 239
- Datamonitor drug assessment summary - page 240
- Pixantrone (BBR-2778; Cell Therapeutics) - page 241
- Drug overview - page 241
- Clinical trial data - page 242
- Use of pixantrone for aggressive NHL - page 243
- Use of pixantrone for indolent NHL - page 246
- Datamonitor comments - page 248
- Problems associated with trying to replace genericized drugs must be overcome - page 248
- Patient recruitment to trials and physician awareness may be an uphill struggle - page 248
- Pixantrone set to benefit from co-licensing agreement with Novartis - page 249
- Forecasts to 2016 - page 250
- Datamonitor drug assessment summary - page 251
- Marqibo (Sphingosomal vincristine; Hana Biosciences) - page 252
- Drug overview - page 252
- Clinical trial data - page 253
- Despite an FDA non-approvable letter and recommendation to initiate a Phase III study in NHL, to date no such trial has been initiated - page 253
- Relapsed aggressive NHL - page 254
- Marqibo as a replacement for vincristine in the R-CHOP regimen for first-line NHL appears to be a promising possibility - page 256
- Marqibo is a potential candidate for the treatment of relapsed/refractory Hodgkin's disease - page 257
- Trials in ALL may hold promise for Marqibo - page 258
- Datamonitor comments - page 259
- Hana Biosciences face a difficult strategic development plan for Marqibo in NHL and shifting the focus to ALL may offer a quicker route to market - page 259
- Overview of cytotoxic therapies for hematological malignancies - page 206
- CHAPTER 7 IMMUNOTHERAPEUTIC AGENTS ANALYSIS AND FORECASTS - page 260
- Overview of immunotherapeutic agents for hematological malignancies - page 260
- Pipeline summary - page 260
- Late-phase pipeline of immunotherapeutic agents - page 261
- Phase II pipeline of immunotherapeutic agents - page 262
- Phase I pipeline of immunotherapeutic agents - page 264
- Comparative forecasts - page 267
- Definition of current comparator therapy - page 270
- Biogen Idec/Genentech/Roche's Rituxan/MabThera (rituximab) - page 270
- Pipeline summary - page 260
- Ceplene (Histamine dihydrochloride; Epicept) - page 272
- Drug overview - page 272
- Clinical trial data - page 272
- Ceplene enters preregistration in Europe as a maintenance therapy in first remission in patients with AML - page 272
- Ceplene plus IL-2 prolongs leukemia-free survival but no significant difference in overall survival observed - page 274
- Datamonitor comments - page 274
- FDA requests additional Phase III trial despite primary endpoints being met - page 274
- EpiCept's lack of oncology experience may hamper Ceplene's market success - page 275
- Forecasts to 2016 - page 275
- Datamonitor drug assessment summary - page 277
- Galiximab (Anti-CD80 MAb; Biogen Idec) - page 278
- Drug overview - page 278
- Clinical trial data - page 279
- Randomized Phase III trial will compare survival of galiximab plus Rituxan with Rituxan alone in relapsed/refractory follicular NHL patients - page 279
- Phase II results show galiximab and Rituxan can be safely combined and can produce promising response rates in follicular NHL patients - page 280
- Datamonitor comments - page 281
- Biogen Idec in a strong position to successfully market galiximab alone - page 281
- Biogen-Idec will need to effectively demonstrate the value of a combination of galiximab and Rituxan to payers - page 281
- Forecasts to 2016 - page 282
- Datamonitor drug assessment summary - page 283
- Lumiliximab (Anti-CD23 MAb; Biogen Idec) - page 284
- Drug overview - page 284
- Clinical trial data - page 285
- Lumiliximab receives Fast Track and Orphan Drug designation for relapsed CLL - page 285
- The addition of lumiliximab to the FCR regimen may produce a higher response rate without additional toxicity - page 286
- Datamonitor comments - page 288
- Lumiliximab on course to become an established addition to the standard treatment for CLL - page 288
- Biogen Idec should look to investigate Lumiliximab as a maintenance therapy - page 289
- Cluster of Differentiation (CD) drugs have become Biogen Idec's specialty - page 289
- Forecasts to 2016 - page 290
- Datamonitor drug assessment summary - page 291
- Ofatumumab (HuMax-CD20; Genmab/GlaxoSmithKline) - page 292
- Drug overview - page 292
- Clinical trial data - page 293
- Genmab hoping ofatumumab will demonstrate a preferred efficacy profile over Rituxan in the clinic - page 293
- Ofatumumab receives Fast Track status for CLL and enters a Phase III trial - page 294
- Genmab initiate a pivotal Phase III trial in follicular NHL - page 296
- Datamonitor comments - page 297
- Ofatumumab may offer hope for Rituxan-insensitive patients - page 298
- Approval of other MAbs being developed by Biogen Idec for NHL and CLL may restrict ofatumumab's potential even further - page 299
- GlaxoSmithKline will offer invaluable experience to Genmab and aid commercialization of ofatumumab - page 299
- Forecasts to 2016 - page 300
- Datamonitor drug assessment summary - page 302
- Zanolimumab (HuMax-CD4; Merck Serono/Genmab) - page 303
- Drug overview - page 303
- Clinical trial data - page 304
- Zanolimumab's Orphan Drug and Fast Track status reflects the high unmet needs in CTCL - page 304
- Zanolimumab may also hold promise for PTCL patients - page 306
- Datamonitor comments - page 307
- The T-cell lymphoma market offers zanolimumab a limited commercial potential - page 307
- Depletion of CD4+ T-cells by zanolimumab may render the patient susceptible to opportunistic infections - page 307
- Forecasts to 2016 - page 308
- Datamonitor drug assessment summary - page 309
- BIOVAXID (Accentia Biopharmaceuticals) - page 310
- Drug overview - page 310
- Clinical trial data - page 311
- BIOVAXID inches closer to approval in the US and European markets for follicular NHL - page 311
- Phase III trial initiated in February 2000 is ongoing and continues to show favorable survival benefits of BIOVAXID - page 312
- Possible association between a specific negative chromasomal translocation following vaccination and disease free survival in follicular NHL - page 313
- Phase II results of BIOVAXID in mantle cell lymphoma are promising - page 313
- Datamonitor comments - page 314
- BIOVAXID competing with FavId and MyVax for first-to-market status - page 314
- BIOVAXID's price-tag should reflect the anticipated competition and current treatment costs - page 314
- Forecasts to 2016 - page 315
- Datamonitor drug assessment summary - page 316
- FavId (Id-KLH; Favrille) - page 317
- Drug overview - page 317
- Clinical trial data - page 318
- FavId receives Fast Track status by the FDA for follicular NHL - page 318
- Single-agent FavId demonstrates an objective response in indolent B-cell NHL - page 321
- Favrille initiates FavId Phase III trial in DLBCL NHL - page 322
- Datamonitor comments - page 323
- FavId competing with BIOVAXID and MyVax to reach the market first - page 323
- Favrille's lack of commercial experience will be a barrier to optimizing market penetration - page 323
- Forecasts to 2016 - page 324
- Datamonitor drug assessment summary - page 325
- MyVax (GTOP-99; Genitope) - page 326
- Drug overview - page 326
- Clinical trial data - page 327
- MyVax received Fast Track status for follicular NHL while Phase III clinical trial approaches completion - page 328
- Phase II clinical trials show greater number of immune responses among previously untreated patients - page 328
- Genitope initiates Phase I/II trial for MyVax in chronic lymphocytic leukemia - page 329
- Follow-up Phase II data of MyVax in mantle cell and diffuse large B-cell lymphoma warrants further investigation - page 329
- Datamonitor comments - page 331
- Despite competition from BIOVAXID and FavId, MyVax increases its commercial potential by targeting an earlier stage treatment - page 331
- With trials ongoing in CLL, MyVax may ultimately emerge as the most adaptable anti-idiotype vaccine - page 331
- Forecasts to 2016 - page 331
- Datamonitor drug assessment summary - page 333
- Comparison of anti-idiotype vaccines - page 335
- Overview of immunotherapeutic agents for hematological malignancies - page 260
- APPENDIX - page 338
- List of tables - page 338
- List of figures - page 348
- Methodology - page 353
- Datamonitor forecast methodology - page 353
- Datamonitor drug assessment summary - page 354
- Abbreviations - page 356
- Contributing experts - page 358
- Key opinion leader interview transcripts - page 358
- Bibliography - page 359
- About Datamonitor - page 371
- About Datamonitor Healthcare - page 371
- Datamonitor Healthcare's therapy area capabilities - page 372
- About the Disease analysis team - page 372
- Disclaimer - page 374
- List of Tables
- Table 1: Late-phase pipeline products for hematological malignancies sales forecasts in the seven major markets ($m), 2007-2016 - page 6
- Table 2: Products in late-phase development for hematological malignancies, 2007 - page 24
- Table 3: Products in Phase II development for hematological malignancies, 2007 - page 27
- Table 4: Products in Phase I development for hematological malignancies, 2007 - page 36
- Table 5: Pipeline products in development for hematological malignancies by Phase and class, 2007 - page 43
- Table 6: Pipeline products by specific hematological malignancy, 2007 - page 53
- Table 7: Companies/Institutes with three or more products in the hematological malignancies pipeline, 2007 - page 58
- Table 8: Novartis' marketed oncology portfolio, 2007 - page 59
- Table 9: Novartis' hematological malignancies pipeline portfolio, 2007 - page 60
- Table 10: Biogen Idec's marketed oncology portfolio, 2007 - page 61
- Table 11: Biogen Idec's hematological malignancies pipeline portfolio, 2007 - page 62
- Table 12: Common mutations involved in tumor development - page 65
- Table 13: Forecast incidence of hematological malignancies in the seven major pharmaceutical markets, 2002-2016 - page 71
- Table 14: Country-specific forecast incidence of the hematological malignancies, 2007 - page 72
- Table 15: Leukemia incidence in the seven major markets, 2002-2016 - page 73
- Table 16: Crude incidence rates of leukemia (per 100,000 population) - page 74
- Table 17: Frequency of leukemia subtypes in the seven major markets - page 75
- Table 18: Incidence of leukemia subtypes in the seven major markets, 2002-2016 - page 75
- Table 19: Country-specific incidence of leukemia subtypes, 2007 - page 76
- Table 20: Lymphoma incidence in the seven major markets, 2002-2016 - page 78
- Table 21: Crude incidence rates of lymphoma (per 100,000 population) - page 79
- Table 22: Non-Hodgkin's lymphoma incidence in the seven major markets, 2002-2016 - page 80
- Table 23: Hodgkin's disease incidence in the seven major markets, 2002-2016 - page 81
- Table 24: Multiple myeloma incidence in the seven major markets, 2002-2016 - page 82
- Table 25: Crude incidence rates of multiple myeloma (per 100,000 population) - page 83
- Table 26: Myelodysplastic syndrome incidence in the seven major markets, 2002-2016 - page 84
- Table 27: Myelodysplastic syndrome incidence in patients aged 65 and over in the seven major markets, 2002-2016 - page 85
- Table 28: Myelodysplastic syndrome incidence in patients under the age of 65 in the seven major markets, 2002-2016 - page 85
- Table 29: Examples of naturally-occurring angiogenesis stimulators - page 97
- Table 30: Recently approved multi-targeted inhibitors, 2007 - page 101
- Table 31: Three main categories of cancer vaccines exist - page 112
- Table 32: FDA information for drugs that received accelerated approval for use to treat hematological malignancies,1999-2006 - page 118
- Table 33: Late-phase pipeline molecular targeted therapies in hematological malignancies, 2007 - page 121
- Table 34: Phase II pipeline molecular targeted therapies in hematological malignancies, 2007 - page 122
- Table 35: Phase I pipeline molecular targeted therapies in hematological malignancies, 2007 - page 125
- Table 36: Forecasting assumptions for late-phase molecular targeted therapies in hematological malignancies in the seven major pharmaceutical markets, 2007 (1 of 2) - page 128
- Table 37: Forecasting assumptions for late-phase molecular targeted therapies in hematological malignancies in the seven major pharmaceutical markets, 2007 (2 of 2) - page 129
- Table 38: Ongoing clinical trials involving Tasigna in hematological malignancies, 2007 - page 133
- Table 39: Trial design and clinical outcomes for a small patient subgroup from the ENACT trial - page 134
- Table 40: Interim Phase II data for Tasigna in Gleevec-resistant or intolerant patients with CML in chronic phase - page 135
- Table 41: Interim Phase II data for Tasigna in Gleevec-resistant or intolerant patients with CML in accelerated phase - page 136
- Table 42: Interim Phase II data for Tasigna in Gleevec-resistant or intolerant patients with CML in blast crisis phase or relapsed/refractory Ph+ ALL - page 137
- Table 43: Phase II results for Tasigna in Gleevec and Sprycel-resistant or intolerant patients with CML in all stages of the disease - page 139
- Table 44: Forecasting assumptions for Tasigna in the seven major pharmaceutical markets, 2007 - page 141
- Table 45: Tasigna sales forecasts in Gleevec-refractory CML ($m), 2007-2016 - page 141
- Table 46: Ongoing clinical trials involving Ceflatonin in hematological malignancies, 2007 - page 144
- Table 47: Interim data for Ceflatonin monotherapy in patients with Gleevec-refractory CML harboring the T315I Bcr-Abl point mutation - page 145
- Table 48: Interim data for Ceflatonin in combination with Gleevec in patients with Gleevec-refractory CML - page 147
- Table 49: Forecasting assumptions for Ceflatonin in the seven major pharmaceutical markets, 2007 - page 149
- Table 50: Ceflatonin sales forecasts in Gleevec-resistant CML ($m), 2007-2016 - page 149
- Table 51: Ongoing clinical trials involving Sarasar in hematological malignancies, 2007 - page 152
- Table 52: Phase I/II study results of Sarasar monotherapy in advanced MDS and CMML - page 153
- Table 53: Forecasting assumptions for Sarasar in the seven major pharmaceutical markets, 2007 - page 156
- Table 54: Sarasar sales forecasts in second-line MDS ($m), 2007-2016 - page 156
- Table 55: Ongoing clinical trials involving Torisel in hematological malignancies, 2007 - page 159
- Table 56: Phase II results of low-dose Torisel in relapsed/refractory MCL patients - page 160
- Table 57: Phase II study of Torisel in relapsed NHL patients - page 162
- Table 58: Forecasting assumptions for Torisel in the seven major pharmaceutical markets, 2007 - page 164
- Table 59: Torisel sales forecasts in third-line MCL ($m), 2007-2016 - page 165
- Table 60: Ongoing clinical trials involving Zarnestra in hematological malignancies, 2007 - page 167
- Table 61: Phase I/II study of Zarnestra in combination with chemotherapy in newly diagnosed AML or high-risk MDS patients - page 170
- Table 62: Phase II results of Zarnestra monotherapy in relapsed/refractory aggressive NHL, 2006 - page 171
- Table 63: Phase II study results of Zarnestra in Juvenile Myelomonocytic leukemia (JMML), 2005 - page 172
- Table 64: Forecasting assumptions for Zarnestra in the seven major pharmaceutical markets, 2007 - page 176
- Table 65: Zarnestra sales forecasts in first-line elderly AML ($m), 2007-2016 - page 176
- Table 66: Ongoing clinical trials involving alvocidib in hematological malignancies, 2007 - page 180
- Table 67: Phase II results of alvocidib followed by cytarabine and Novantrone in AML and ALL - page 182
- Table 68: Ongoing clinical trials involving enzastaurin in hematological malignancies, 2007 - page 184
- Table 69: Phase II results of enzastaurin in relapsed DLBCL - page 185
- Table 70: Forecasting assumptions for enzastaurin in the seven major pharmaceutical markets, 2007 - page 188
- Table 71: Enzastaurin sales forecasts in DLBCL ($m), 2007-2016 - page 188
- Table 72: Ongoing clinical trial involving lestaurtinib in hematological malignancies, 2007 - page 191
- Table 73: Interim Phase II/III results of lestaurtinib and chemotherapy in patients with relapsed AML harboring Flt-3 activating mutations - page 192
- Table 74: Forecasting assumptions for lestaurtinib in the seven major pharmaceutical markets, 2007 - page 194
- Table 75: Lestaurtinib sales forecasts in second-line AML ($m), 2007-2016 - page 195
- Table 76: Ongoing clinical trials involving Genasense in hematological malignancies, 2007 - page 197
- Table 77: Forecasting assumptions for Genasense in the seven major pharmaceutical markets, 2007 - page 203
- Table 78: Genasense sales forecasts in first-line elderly AML ($m), 2007-2016 - page 203
- Table 79: Late-phase pipeline cytotoxic therapies in hematological malignancies, 2007 - page 207
- Table 80: Phase II pipeline cytotoxic therapies in hematological malignancies, 2007 - page 208
- Table 81: Phase I pipeline cytotoxic therapies in hematological malignancies, 2007 - page 210
- Table 82: Forecasting assumptions for late-phase cytotoxic therapies in hematological malignancies in the seven major pharmaceutical markets, 2007 - page 211
- Table 83: Ongoing clinical trials involving Clolar in hematological malignancies, 2007 - page 214
- Table 84: Phase I study of Clolar with or without low-dose cytarabine as induction therapy for elderly AML patients - page 216
- Table 85: Phase II results of Clolar and cytarabine in elderly AML patients - page 217
- Table 86: Phase II results of single-agent Clolar in elderly AML patients with an unfavorable cytogenetic profile (1 of 2) - page 218
- Table 87: Phase II results of single-agent Clolar in elderly AML patients with an unfavorable cytogenetic profile (2 of 2) - page 218
- Table 88: Phase II results of Clolar in pediatric relapsed/refractory AML - page 219
- Table 89: Forecasting assumptions for Clolar in the seven major pharmaceutical markets, 2007 - page 222
- Table 90: Clolar sales forecasts in relapsed/refractory AML ($m), 2007-2016 - page 223
- Table 91: Ongoing clinical trials involving Dacogen in hematological malignancies, 2007 - page 225
- Table 92: Phase II study of low-dose Dacogen in newly diagnosed elderly AML patients - page 226
- Table 93: Forecasting assumptions for Dacogen in the seven major pharmaceutical markets, 2007 - page 229
- Table 94: Dacogen sales forecasts in AML ($m), 2007-2016 - page 230
- Table 95: Ongoing clinical trials involving Cloretazine in hematological malignancies, 2007 - page 232
- Table 96: Distribution by stratum of AML patients in Phase III trial of Cloretazine - page 234
- Table 97: Phase II results of Cloretazine in AML and high-risk MDS patients (1 of 2) - page 235
- Table 98: Treatment schedule of Temodar and Cloretazine in a Phase I study in hematological malignancies - page 236
- Table 99: Forecasting assumptions for Cloretazine in the seven major pharmaceutical markets, 2007 - page 239
- Table 100: Cloretazine sales forecasts in relapsed/refractory AML ($m), 2007-2016 - page 239
- Table 101: Ongoing clinical trials involving pixantrone in hematological malignancies, 2007 - page 243
- Table 102: Phase II interim results of pixantrone in the CPOP regimen in relapsed aggressive NHL - page 245
- Table 103: Phase II results of pixantrone as part of the BSHAP regimen in aggressive NHL patients experiencing their first relapse - page 246
- Table 104: Phase I/II trial results of pixantrone as part of the FPD-R regimen, to replace mitoxantrone in FND-R in indolent NHL - page 247
- Table 105: Forecasting assumptions for pixantrone in the seven major pharmaceutical markets, 2007 - page 250
- Table 106: Pixantrone sales forecasts in aggressive NHL ($m), 2007-2016 - page 251
- Table 107: Ongoing clinical trials involving Marqibo in hematological malignancies, 2007 - page 253
- Table 108: Phase II results of Marqibo in secondary relapsed NHL patients - page 255
- Table 109: Phase II results of Marqibo plus Rituxan in multiply relapsed DLBCL patients - page 256
- Table 110: Phase II results of Marqibo replacing vincristine in the R-CHOP regimen for first-line aggressive NHL - page 257
- Table 111: Phase II results of single agent Marqibo in relapsed/refractory Hodgkin's disease patients - page 258
- Table 112: Late-phase pipeline immunotherapeutic agents in hematological malignancies, 2007 - page 261
- Table 113: Phase II pipeline immunotherapeutic agents in hematological malignancies, 2007 - page 262
- Table 114: Phase I pipeline immunotherapeutic agents in hematological malignancies, 2007 - page 264
- Table 115: Forecasting assumptions for late-phase immunotherapeutic agents in hematological malignancies in the seven major pharmaceutical markets, 2007 (1 of 3) - page 267
- Table 116: Forecasting assumptions for late-phase immunotherapeutic agents in hematological malignancies in the seven major pharmaceutical markets, 2007 (2 of 3) - page 268
- Table 117: Forecasting assumptions for late-phase immunotherapeutic agents in hematological malignancies in the seven major pharmaceutical markets, 2007 (3 of 3) - page 269
- Table 118: Approved indications for Rituxan in the US and EU, 2006 - page 271
- Table 119: Outline of Phase III trial involving Ceplene in AML - page 273
- Table 120: Forecasting assumptions for Ceplene in the seven major pharmaceutical markets, 2007 - page 276
- Table 121: Ceplene sales forecasts in AML ($m), 2007-2016 - page 276
- Table 122: Ongoing clinical trial involving galiximab in hematological malignancies, 2007 - page 279
- Table 123: Phase II study of galiximab in combination with Rituxan in relapsed/refractory follicular NHL - page 280
- Table 124: Forecasting assumptions for galiximab in the seven major pharmaceutical markets, 2007 - page 282
- Table 125: Galiximab sales forecasts in follicular NHL ($m), 2007-2016 - page 283
- Table 126: Ongoing clinical trial involving lumiliximab in hematological malignancies, 2007 - page 285
- Table 127: Comparison of results from a Phase I/II study of lumiliximab in combination with FCR in relapsed/refractory CLL - page 287
- Table 128: Biogen Idec's Cluster of Differentiation (CD) targeted drugs, 2007 - page 290
- Table 129: Forecasting assumptions for lumiliximab in the seven major pharmaceutical markets, 2007 - page 290
- Table 130: Lumiliximab sales forecasts in relapsed/refractory CLL ($m), 2007-2016 - page 291
- Table 131: Ongoing clinical trial involving ofatumumab in hematological malignancies, 2007 - page 293
- Table 132: Phase I/II results of ofatumumab in relapsed/refractory CLL - page 295
- Table 133: Interim Phase I/II results of ofatumumab in relapsed/refractory follicular NHL - page 297
- Table 134: GlaxoSmithKline's marketed oncology portfolio, 2007 - page 300
- Table 135: Forecasting assumptions for ofatumumab in the seven major pharmaceutical markets, 2007 - page 301
- Table 136: Ofatumumab sales forecasts in relapsed/refractory CLL and follicular NHL ($m), 2007-2016 - page 301
- Table 137: Ongoing clinical trial involving zanolimumab in hematological malignancies, 2007 - page 304
- Table 138: Phase II results of zanolimumab in mycosis fungoides CTCL - page 305
- Table 139: Interim Phase II results of zanolimumab in PTCL patients - page 306
- Table 140: Forecasting assumptions for zanolimumab in the seven major pharmaceutical markets, 2007 - page 308
- Table 141: Zanolimumab sales forecasts in CTCL ($m), 2007-2016 - page 309
- Table 142: Ongoing clinical trials involving BIOVAXID in hematological malignancies, 2007 - page 311
- Table 143: Forecasting assumptions for BIOVAXID in the seven major pharmaceutical markets, 2007 - page 315
- Table 144: BIOVAXID sales forecasts in follicular NHL ($m), 2007-2016 - page 315
- Table 145: Ongoing clinical trials involving FavId in hematological malignancies, 2007 - page 318
- Table 146: Interim results of FavId monotherapy Phase III trial in follicular NHL: Response to Rituxan, December 2006 - page 319
- Table 147: Forecasting assumptions for FavId in the seven major pharmaceutical markets, 2007 - page 324
- Table 148: FavId sales forecasts in follicular NHL and DLBCL ($m), 2007-2016 - page 324
- Table 149: Ongoing clinical trial involving MyVax in hematological malignancies, 2007 - page 328
- Table 150: Phase II interim results of MyVax in MCL and DLBCL NHL patients, (1 of 2) - page 330
- Table 151: Phase II interim results of MyVax in MCL and DLBCL NHL patients, (2 of 2) - page 330
- Table 152: Forecasting assumptions for MyVax in the seven major pharmaceutical markets, 2007 - page 332
- Table 153: MyVax sales forecasts in follicular NHL ($m), 2007-2016 - page 332
- Table 154: Comparisons of the late-phase anti-idiotype vaccines, 2007 - page 335
- Table 155: Datamonitor drug assessment parameters - page 354
- Table 156: Abbreviations used in Pipeline Insight: Hematological Malignancies (1 of 2) - page 356
- Table 157: Abbreviations used in Pipeline Insight: Hematological Malignancies (2 of 2) - page 357
- List of Figures
- Figure 1: Pipeline molecular targeted therapies sales forecasts ($m), 2007-2016 - page 7
- Figure 2: Pipeline cytotoxic therapies sales forecasts ($m), 2007-2016 - page 8
- Figure 3: Pipeline immunotherapeutic agents sales forecasts ($m), 2007-2016 - page 9
- Figure 4: Clinical and commercial attractiveness of pipeline molecular targeted therapies in development for hematological malignancies, 2007 - page 10
- Figure 5: Clinical and commercial attractiveness of pipeline cytotoxic therapies in development for hematological malignancies, 2007 - page 11
- Figure 6: Clinical and commercial attractiveness of pipeline immunotherapeutic agents in development for hematological malignancies, 2007 - page 12
- Figure 7: Pipeline products in development for hematological malignancies by Phase and class, 2007 - page 44
- Figure 8: Pipeline products in development for hematological malignancies by phase, 2007 - page 45
- Figure 9: Molecular targeted therapies pipeline candidates for hematological malignancies by developmental phase, 2007 - page 46
- Figure 10: Cytotoxic pipeline candidates for hematological malignancies by developmental phase, 2007 - page 47
- Figure 11: Immunotherapeutic pipeline candidates for hematological malignancies by developmental phase, 2007 - page 48
- Figure 12: Pipeline products in development for hematological malignancies by class, 2007 - page 49
- Figure 13: Pipeline products in development for hematological malignancies by subcategory within each class, 2007 - page 50
- Figure 14: Leukemia, lymphoma and myeloma pipeline products, 2007 - page 52
- Figure 15: Pipeline products by specific hematological malignancy, 2007 - page 54
- Figure 16: Late-phase pipeline products by specific hematological malignancy, 2007 - page 56
- Figure 17: Pipeline products in development for hematological malignancies by type of company, 2007 - page 57
- Figure 18: Global oncology sales ($m), 2002-2011 - page 69
- Figure 19: Oncology pipeline including supportive care, 2006 - page 70
- Figure 20: Forecast incidence of hematological malignancies in the seven major pharmaceutical markets, 2007 and 2016 - page 71
- Figure 21: Country specific forecast incidence of the hematological malignancies in 2007 - page 72
- Figure 22: Leukemia incidence in the seven major markets, 2007 and 2016 - page 74
- Figure 23: Incidence of leukemia subtypes in the seven major markets, 2007 and 2016 - page 76
- Figure 24: Country-specific incidence of acute leukemias, 2007 - page 77
- Figure 25: Country-specific incidence of chronic leukemias, 2007 - page 77
- Figure 26: Lymphoma incidence in the seven major markets, 2007 and 2016 - page 79
- Figure 27: Non-Hodgkin's lymphoma incidence in the seven major markets, 2007 and 2016 - page 80
- Figure 28: Hodgkin's disease incidence in the seven major markets, 2007 and 2016 - page 81
- Figure 29: Multiple myeloma incidence in the seven major markets, 2007 and 2016 - page 83
- Figure 30: Myelodysplastic syndrome incidence in the seven major markets, 2007 and 2016 - page 84
- Figure 31: Myelodysplastic syndrome incidence by age in the seven major markets, 2007 - page 86
- Figure 32: Incidence increases, while the rate of cure and death reduces disease prevalence - page 87
- Figure 33: Unmet needs in cancer, 2007 - page 91
- Figure 34: The process of tumor angiogenesis - page 97
- Figure 35: Clinical and commercial attractiveness of pipeline molecular targeted therapies in development for hematological malignancies, 2007 - page 120
- Figure 36: Pipeline molecular targeted therapies sales forecasts ($m), 2007-2016 - page 130
- Figure 37: Tasigna sales forecasts in Gleevec-refractory CML($m), 2007-2016 - page 142
- Figure 38: Clinical and commercial attractiveness of Tasigna, 2007 - page 143
- Figure 39: Ceflatonin sales forecasts in Gleevec-resistant CML ($m), 2007-2016 - page 150
- Figure 40: Clinical and commercial attractiveness of Ceflatonin, 2007 - page 151
- Figure 41: Sarasar sales forecasts in second-line MDS ($m), 2007-2016 - page 157
- Figure 42: Clinical and commercial attractiveness of Sarasar, 2007 - page 158
- Figure 43: Stratification of patients in Phase II study of Torisel plus Rituxan in second-line MCL patients - page 161
- Figure 44: Torisel sales forecasts in third-line MCL ($m), 2007-2016 - page 165
- Figure 45: Clinical and commercial attractiveness of Torisel, 2007 - page 166
- Figure 46: Zarnestra sales forecasts in first-line elderly AML ($m), 2007-2016 - page 177
- Figure 47: Clinical and commercial attractiveness of Zarnestra, 2007 - page 178
- Figure 48: Enzastaurin sales forecasts in DLBCL ($m), 2007-2016 - page 189
- Figure 49: Clinical and commercial attractiveness of enzastaurin, 2007 - page 190
- Figure 50: Lestaurtinib sales forecasts in second-line AML ($m), 2007-2016 - page 195
- Figure 51: Clinical and commercial attractiveness of lestaurtinib, 2007 - page 196
- Figure 52: Genasense sales forecasts in first-line elderly AML ($m), 2007-2016 - page 204
- Figure 53: Clinical and commercial attractiveness of Genasense, 2007 - page 205
- Figure 54: Clinical and commercial attractiveness of pipeline cytotoxic therapies in development for hematological malignancies, 2007 - page 206
- Figure 55: Pipeline cytotoxic therapies sales forecasts ($m), 2007-2016 - page 212
- Figure 56: Clolar sales forecasts in relapsed/refractory AML ($m), 2007-2016 - page 223
- Figure 57: Clinical and commercial attractiveness of Clolar, 2007 - page 224
- Figure 58: Dacogen sales forecasts in AML ($m), 2007-2016 - page 230
- Figure 59: Clinical and commercial attractiveness of Dacogen, 2007 - page 231
- Figure 60: Phase III clinical trial design for Cloretazine in second-line AML - page 233
- Figure 61: Cloretazine sales forecasts in relapsed/refractory AML ($m), 2007-2016 - page 240
- Figure 62: Clinical and commercial attractiveness of Cloretazine, 2007 - page 241
- Figure 63: Chemical structures of mitoxantrone and pixantrone - page 242
- Figure 64: Phase III clinical trial design for pixantrone in third-line aggressive NHL - page 244
- Figure 65: Pixantrone sales forecasts in aggressive NHL ($m), 2007-2016 - page 251
- Figure 66: Clinical and commercial attractiveness of pixantrone, 2007 - page 252
- Figure 67: Clinical and commercial attractiveness of pipeline immunotherapeutic agents in development for hematological malignancies, 2007 - page 260
- Figure 68: Pipeline immunotherapeutic agents sales forecasts ($m), 2007-2016 - page 270
- Figure 69: Protocol outline for Phase III trial involving Ceplene in AML - page 273
- Figure 70: Ceplene sales forecasts in AML ($m), 2007-2016 - page 277
- Figure 71: Clinical and commercial attractiveness of Ceplene, 2007 - page 278
- Figure 72: Galiximab sales forecasts in follicular NHL ($m), 2007-2016 - page 283
- Figure 73: Clinical and commercial attractiveness of galiximab, 2007 - page 284
- Figure 74: Lumiliximab sales forecasts in relapsed/refractory CLL ($m), 2007-2016 - page 291
- Figure 75: Clinical and commercial attractiveness of lumiliximab, 2007 - page 292
- Figure 76: Ofatumumab sales forecasts in relapsed/refractory CLL and follicular NHL ($m), 2007-2016 - page 302
- Figure 77: Clinical and commercial attractiveness of ofatumumab, 2007 - page 303
- Figure 78: Zanolimumab sales forecasts in CTCL ($m), 2007-2016 - page 309
- Figure 79: Clinical and commercial attractiveness of zanolimumab, 2007 - page 310
- Figure 80: BIOVAXID sales forecasts in follicular NHL ($m), 2007-2016 - page 316
- Figure 81: Clinical and commercial attractiveness of BIOVAXID, 2007 - page 317
- Figure 82: Trial design of Phase II study of FavId in progressive NHL - page 322
- Figure 83: FavId sales forecasts in follicular NHL and DLBCL ($m), 2007-2016 - page 325
- Figure 84: Clinical and commercial attractiveness of FavId, 2007 - page 326
- Figure 85: Genitope's personalized immunotherapy (MyVax) production system - page 327
- Figure 86: MyVax sales forecasts in follicular NHL ($m), 2007-2016 - page 333
- Figure 87: Clinical and commercial attractiveness of MyVax, 2007 - page 334
- Figure 88: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 - page 355
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