Molecular Targeted Cancer Therapies - More drugs on the market, more targets in the pipeline
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Oncology pharmaceutical analysis team - page 2
- Nish Saini - Director of Oncology - page 2
- About the Oncology pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of analysis - page 3
- Datamonitor insight into the targeted therapies market - page 3
- CHAPTER 2 PIPELINE OVERVIEW - page 11
- Pipeline overview - page 11
- Pipeline by developmental phase and class of drug - page 14
- The cell cycle and apoptosis targeted agents make up the largest number of MTTs in the pipeline - page 14
- Segmentation of drugs by developmental phase reflects attrition rate of drug development in the oncology market - page 17
- Targeted therapy remains a promising anticancer drug development strategy - page 17
- Developmental agents by phase for each class - page 17
- Pipeline by indication - page 21
- MTTs are being investigated in 29 different cancers - page 21
- The 'big four' tumor types are the most popular indications for development - page 23
- MTTs are being investigated in 29 different cancers - page 21
- Pipeline by mode of action - page 24
- Pipeline MTTs are being directed against a huge variety and combination of molecular targets - page 24
- The VEGF/VEGFR family remains the focus of development for MTTs - page 26
- Pipeline by company - page 28
- There are over 150 different companies developing targeted therapies - page 28
- Top three companies in terms of number of pipeline MTT products are Pfizer, Novartis and GlaxoSmithKline - page 29
- Pfizer - page 30
- Novartis - page 32
- GlaxoSmithKline - page 34
- Key metrics - page 37
- Datamonitor pipeline assessment summary - page 44
- CHAPTER 3 PIPELINE DYNAMICS - page 51
- A diverse range of disease subtypes - page 51
- Genetic basis of cancer evolution - page 51
- Tumorigenesis is the result of co-operative accumulated mutations - page 53
- Existing pharmacotherapy approaches provide limited treatment benefit - page 53
- Cytotoxic drugs lack specificity - page 54
- Hormonal or endocrine therapy provides incremental benefit in selected tumors - page 54
- Optimizing current treatment strategies is paramount - page 54
- The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy - page 54
- Dynamic cancer market offers significant commercial opportunity - page 55
- Ongoing sales growth drives the market - page 55
- Intensive R&D produces a rich developmental pipeline - page 56
- Growing patient population and significant unmet needs propel innovation in the cancer market - page 57
- Cancer epidemiology - an expanding patient base - page 57
- Significant areas of unmet need persist - page 62
- Clinical and strategic threats to the commercialization of cancer drugs - page 66
- Progressively rising R&D costs threaten industry productivity - page 66
- High attrition rates can be mitigated by improved strategic decision-making - page 67
- Lengthening drug approval process - a consequence of increased regulatory demands - page 67
- Pharmacoeconomic pressures drive payers to implement restrictive pricing and reimbursement policies - page 68
- Therapeutic and generic competition reduces periods of market exclusivity - page 68
- Segmentation of market will require changes in clinical trial methodology - page 69
- Progressively rising R&D costs threaten industry productivity - page 66
- CHAPTER 4 MARKET DEFINITION & PIPELINE CLASSIFICATION - page 70
- Targeted therapies overview - page 70
- The development of molecular targeted therapies - page 70
- Current therapies are less cancer cell-specific - page 70
- The strategy is to target the specific survival factors of a tumor - page 70
- Key issue is the identification of targets unique to cancer cells - page 71
- The development of molecular targeted therapies - page 70
- Market definition - page 71
- L1X3 - Antineoplastic monoclonal antibodies - page 71
- L1X9 - All other antineoplastics - page 72
- Classification of pipeline products - page 73
- Angiogenesis inhibitors - page 73
- Angiogenesis as a normal biological process - page 73
- Angiogenesis is known to be abberant in tumor cell proliferation - page 74
- Angiogenesis inhibitors as viable antitumor agents can target a number of pathways - page 75
- At present, only one angiogenesis inhibitor exists in the market - page 76
- Single-target signal transduction inhibitors - page 76
- A plethora of potential targets exist along the signaling cascade - page 76
- Several signal transduction inhibitors have reached the market, bringing with them their own sets of issues for consideration - page 77
- Multi-targeted inhibitors - page 78
- Multi-targeted inhibitors have certain advantages over single targeted agents - page 78
- Approval of three multi-targeted inhibitors - page 79
- Cell cycle and apoptosis targeted inhibitors - page 80
- Only one cell cycle inhibitor has entered Phase III - page 80
- Cell death can be induced via a number of different pathways - page 80
- To date, only one apoptosis stimulator has reached the market - page 81
- Epigenetic modulators - page 81
- Despite relative immaturity of development in this class of drugs, the potential to enhance current therapies exists - page 82
- Immunomodulatory and immunoconjugated therapeutics - page 82
- Antibody-based technologies are an effective anticancer approach - page 82
- Angiogenesis inhibitors - page 73
- Pipeline comparator - page 83
- Current market situation - page 84
- Targeted therapies overview - page 70
- CHAPTER 5 MARKETED PRODUCTS FORECAST ANALYSIS - page 87
- Country-specific assumptions and effects - page 87
- Effect of Medicare Modernization Act in the US - page 87
- Biennial price cuts in Japan - page 87
- National Institute of Clinical Excellence in the UK - page 87
- Generic erosion assumptions - page 88
- Product assumptions and effects - page 89
- Angiogenesis inhibitors - page 89
- Genentech/Roche's Avastin (bevacizumab) - page 89
- Single-target signal transduction inhibitors - page 92
- ImClone/Bristol-Myers Squibb/Merck KGaA's Erbitux (cetuximab) - page 92
- Novartis's Gleevec/Glivec (imatinib) - page 95
- Genentech/Roche's Herceptin (trastuzumab) - page 97
- AstraZeneca's Iressa (gefitinib) - page 99
- OSI Pharmaceuticals/Genentech/Roche's Tarceva (erlotinib) - page 101
- Eisai's Targretin (bexarotene) - page 103
- Multi-targeted inhibitors - page 105
- Onyx Pharmaceuticals/Bayer AG's Nexavar (sorafenib) - page 105
- Bristol-Myers Squibb's Sprycel (dasatinib) - page 108
- Pfizer's Sutent (sunitinib) - page 110
- Cell cycle and apoptosis targeted agents - page 113
- Ortho Biotech/Millennium Pharmaceuticals' Velcade (bortezomib) - page 113
- Immunomodulatory and immunoconjugated therapeutics - page 115
- GlakoSmithKline's Bexxar (tositumomab) - page 115
- Schering AG/Berlex's Campath (MabCampath; alemtuzumab) - page 116
- Wyeth's Mylotarg (gemtuzumab) - page 117
- Biogen IDEC/Genentech/Roche's Rituxan/MabThera (rituximab) - page 118
- Biogen Idec/Schering AG's Zevalin (ibritumomab) - page 120
- Eisai's Ontak (Onzar; denileukin) - page 120
- Angiogenesis inhibitors - page 89
- Forecasts - page 121
- Country-specific assumptions and effects - page 87
- CHAPTER 6 PIPELINE ANGIOGENESIS INHIBITORS ANALYSIS & FORECASTS - page 122
- Pipeline overview - page 122
- AstraZeneca's AZD2171 - page 125
- Drug Profile - page 125
- Clinical Trial Data - page 126
- AZD2171 as a monotherapeutic agent - page 128
- AZD2171 in combination with chemotherapy appears to be a promising approach - page 128
- AZD2171 has potential in NSCLC in combination with standard chemotherapy regimens and with Iressa - page 129
- Datamonitor Comments - page 130
- As a potentially more potent inhibitor of angiogenesis, and given its formulation, AZD2171's future may be very promising - page 130
- AstraZeneca's strength in the oncology market will be key in AZD2171's success - page 130
- GlaxoSmithKline's Pazopanib (GW 786034) - page 131
- Drug Profile - page 131
- Clinical Trial Data - page 131
- Pazopanib as a possible second-line monotherapy treatment for metastatic RCC - page 132
- Co-administration with Tykerb may alter the pharmacokinetics of pazopanib - page 133
- Other Indications - page 133
- Datamonitor Comments - page 134
- Initial approval in RCC will force pazopanib to compete against the already approved Sutent and Nexavar - page 134
- Tykerb may well enhance the success of pazopanib but at what price? - page 135
- Novartis/Schering AG's Vatalanib (PTK-787) - page 135
- Drug Profile - page 135
- Clinical Trial Data - page 135
- Anticipated regulatory filing for vatalanib in CRC is becoming increasingly unlikely following disappointing CONFIRM-1 and CONFIRM-2 interim results - page 137
- Recent update of vatalanib in Gleevec-resistant GIST patients - page 138
- Recent update of the Phase II GOAL Study in NSCLC - page 138
- Novartis/Schering AG adopt an aggressive approach, investigating vatalanib in a number of indications - page 139
- Datamonitor Comments - page 139
- Vatalanib unlikely to compete with Avastin in the metastatic CRC market - page 139
- Schering AG's and particularly Novartis's prior oncology experience will be invaluable to vatalanib - page 140
- Novartis and Schering AG are determined to exploit any commercial potential vatalanib may have - page 140
- Sanofi Aventis/Regeneron's VEGF-Trap - page 141
- Drug Profile - page 141
- Clinical Trial Data - page 141
- VEGF-Trap enters Phase III for ovarian cancer - page 142
- VEGF-Trap in Phase II for NSCLC and RCC - page 143
- Selecetd Phase I clinical studies in solid tumors - page 143
- VEGF-Trap demonstrates similar side effects to Avastin - page 145
- Datamonitor Comments - page 145
- Fierce competition with Avastin in the ovarian cancer market - page 145
- Presence in oncology field will aid commercialisation of VEGF-Trap - page 147
- Forecasts - page 147
- Datamonitor drug assessment summary - page 149
- CHAPTER 7 PIPELINE SINGLE-TARGET SIGNAL TRANSDUCTION INHIBITORS ANALYSIS & FORECASTS - page 152
- Pipeline overview - page 152
- Amgen's Vectibix (panitumumab; ABX-EGF) - page 155
- Drug Profile - page 155
- Overexpression of EGFR makes an ideal target for Vectibix development - page 155
- Clinical Trial Data - page 155
- Vectibix is approved for metastatic CRC and showing promise in a range of other treatment settings - page 157
- Addition of Vectibix does not enhance standard chemotherapy in NSCLC - page 158
- Vectibix fails as a single agent in RCC - page 159
- Main side effect is a potential indicator of Vectibix activity - page 159
- Datamonitor Comments - page 159
- Humanized nature of Vectibix will challenge its competitor EGFR inhibitors - page 159
- Vectibix versus Erbitux - page 160
- Third-line setting for metastatic CRC is a good place to start - page 161
- Amgen should focus on combination regimens while considering the intellectual property issues - page 162
- Potential development of a biomarker for Vectibix - page 162
- Amgen's presence will ensure success with profitability increasing by targeting earlier lines of therapy - page 163
- Drug Profile - page 155
- Schering-Plough's Sarasar (Lonafarnib) - page 163
- Drug Profile - page 163
- Clinical Trial Data - page 163
- Main focus of Sarasar development in MDS, where greatest antitumor activity is shown - page 164
- Farnesyl transferase inhibitors predominately in hematological disorders - page 165
- Lack of efficacy has led to termination of pivotal Phase III trial in NSCLC - page 165
- Lack of clinical data makes it difficult to judge Sarasar's potential in breast cancer - page 166
- Initiation of a Phase II trial in Ovarian Cancer - page 166
- Benefit shown in advanced head and neck cancer, although no further trials have been announced - page 166
- Currently no further trials planned for pancreatic cancer, urothelial carcinoma and colorectal cancer - page 167
- Mild toxicity in the majority of patients, although grade 3 events do occur - page 167
- Datamonitor Comments - page 167
- Sarasar's chances for approval will be delayed beyond 2007 - page 167
- Sarasar racing against Johnson & Johnson's Zarnestra as the first farnesyl transferase inhibitor to reach the market - page 168
- Presence in oncology market will aid commercialization of Sarasar - page 169
- Abbott Laboratories' Xinlay (atrasentan) - page 169
- Drug Profile - page 169
- Xinlay's target receptor plays a key role in cancer cell proliferation - page 169
- Clinical Trial Data - page 170
- FDA do not approve Xinlay for prostate cancer - page 170
- Other trials - page 172
- Datamonitor Comments - page 173
- Despite its rejection by the FDA, Xinlay's future may still be promising - page 173
- Abbott's favorable position in the prostate cancer market will be invaluable - page 173
- Drug Profile - page 169
- Wyeth's Torisel (Temsirolimus; CCI-779) - page 174
- Drug Profile - page 174
- Temsirolimus inhibits a key pathway in tumor cell proliferation - page 174
- Clinical Trial Data - page 174
- Promising Phase III results in RCC reported at ASCO 2006 - page 175
- Torisel showing promise in mantle cell lymphoma - page 176
- Torisel trial in breast cancer is discontinued - page 177
- Combination studies with Torisel initiated in malignant melanoma - page 177
- Combination studies with Torisel initiated in glioblastome multiforme - page 177
- Torisel as a monotherapy - page 178
- Mild toxicity means Torisel is well tolerated - page 178
- Datamonitor Comments - page 178
- Targeting poor prognosis patients may eventually accelerate Torisel's expansion within RCC - page 178
- Torisel will have to face Velcade in the MCL market - page 179
- Prior commercialization of Mylotarg and Neumega will provide Wyeth with valuable insight into the oncology market - page 179
- Drug Profile - page 174
- Janssen/Johnson & Johnson's Zarnestra (tipifarnib) - page 180
- Drug Profile - page 180
- Clinical Trial Data - page 180
- Following rejection of NDA, the FDA requires Phase III data for Zarnestra in AML before regulatory approval can be considered - page 182
- Zarnestra shows activity in MDS - page 184
- Zarnestra development in breast cancer remains in Phase II trials - page 184
- Following modest activity in brain cancer, further trials have been initiated - page 184
- Initiation of Phase II trials in large granular lymphocyte leukemia and malignant melanoma - page 186
- Negative Phase III trial results caused termination of development in solid tumors - page 187
- Phase I trial is ongoing for Zarnestra in combination with chemotherapy in advanced NSCLC - page 188
- Mild toxicity is particularly significant since Zarnestra's main indication is for elderly AML patients where quality of life is a major issue - page 188
- Datamonitor Comments - page 188
- Schering-Plough's Sarasar catching up with Zarnestra as the first farnesyl transferase inhibitor to reach the market - page 188
- Johnson & Johnson limiting Zarnestra's target population in the short term - page 189
- Johnson & Johnson's experience will be invaluable to Zarnestra - page 190
- YM Bioscience's TheraCIM (Theraloc; Nimotuzumab) - page 190
- Drug Profile - page 190
- Clinical Trial Data - page 191
- Phase III for pediatric pontine (brain stem) glioma - page 191
- Phase II pediatric trial demonstrated activity - page 191
- Positive efficacy and favorable toxicity data for Phase II trial results of TheraCIM - page 192
- Datamonitor Comments - page 192
- Phase III trial results required to verify the efficacy of this agent - page 192
- Forecasts - page 193
- Datamonitor drug assessment summary - page 196
- CHAPTER 8 PIPELINE MULTI-TARGETED INHIBITORS ANALYSIS & FORECASTS - page 199
- Pipeline overview - page 199
- GlaxoSmithKline's Tykerb/Tycerb (Lapatinib) - page 203
- Drug Profile - page 203
- Tykerb is unique among the EGFR inhibitors, targeting two receptor tyrosine kinases - page 203
- Clinical Trial Data - page 203
- Tykerb set to penetrate the breast cancer market - page 205
- Tykerb did not meet the primary endpoint in mRCC Phase III study - page 211
- Tykerb monotherapy shows no activity in BTC but shows promise in HCC - page 212
- Tykerb appears to have little activity in SCCHN - page 212
- Other clinical trials - page 213
- Datamonitor Comments - page 213
- Tykerb's dual ErbB targeting mechanism will lead to a significant patient potential - page 213
- Tykerb and capecitabine combination looking to become the gold-standard for second-line metastatic beast cancer - page 213
- Tykerb's ability to threaten Herceptin still hangs in the balance - page 214
- GSK also looks to secure a future for Tykerb as part of combination regimens - page 215
- GSK's limited oncology portfolio will be bolstered by the arrival of Tykerb - page 215
- Drug Profile - page 203
- ChemGenex Pharmaceuticals' Ceflatonin (CGX-635, Myelostat) - page 216
- Drug Profile - page 216
- Clinical Trial Data - page 216
- Ceflatonin aims to restore Gleevec sensitivity in CML patients - page 217
- Datamonitor Comments - page 218
- Despite convincing clinical benefit, Ceflatonin will face strong competition from Bristol-Myers Squibb's Sprycel and Novartis's Tasigna - page 218
- Ipsen's Somatuline (Lanreotide) - page 219
- Drug Profile - page 219
- Clinical Trial Data - page 219
- Somatuline enters Phase III for entero-pancreatic endocrine tumors - page 220
- Somatuline in neuroendocrine tumors - page 220
- Datamonitor Comments - page 220
- Somatuline will benefit from its marketed status - page 220
- Somatuline may end up competing with Sutent in neuroendocrine tumors - page 221
- Novartis's Tasigna (Nilotinib, AMN-107) - page 221
- Drug Profile - page 221
- Clinical Trial Data - page 221
- Tasigna receives fast track and orphan drug status for Gleevec-resistant CML - page 222
- Promising Phase II interim data reported - page 222
- Only one BCR-ABL mutation is insensitive to Tasigna - page 224
- Tasigna shows promise for Gleevec-resistant metastatic GIST patients - page 224
- Datamonitor Comments - page 225
- Tasigna ready to challenge Bristol-Myers Squibb's already approved Sprycel - page 225
- Novartis looking to expand its leading role in the CML therapy market - page 225
- AstraZeneca's Zactima (Vandetanib; ZD6474) - page 225
- Drug Profile - page 225
- Clinical Trial Data - page 226
- Zactima granted Orphan Drug designation and Fast Track status for Thyroid cancer - page 227
- Following promising Phase II results, a Phase III trial of Zactima in combination with Taxotere has begun in NSCLC - page 228
- Zactima shown to be more effective than Gefitinib in NSCLC - page 229
- Initiation of Phase II trial in Glioma - page 229
- Datamonitor Comments - page 230
- Zactima set to enjoy a monopoly of thyroid cancer niche market - page 230
- Only two other agents share the multi-targeted characteristics of Zactima - page 230
- Zactima will need to overcome Tarceva in the NSCLC market - page 231
- AstraZeneca's strength in the oncology market will be key in Zactima's success - page 231
- Eli Lilly's Enzastaurin (LY317615) - page 232
- Drug Profile - page 232
- Clinical Trial Data - page 232
- Enzastaurin granted Orphan Drug status by the EMEA and FDA - page 234
- Enzastaurin in Phase III for Glioblastoma Multiforme - page 234
- Enzastaurin in Phase III for B-Cell Lymphoma - page 235
- Other clinical trials - page 235
- Datamonitor Comments - page 236
- Enzastaurin fulfills significant unmet needs in recurrent GBM setting - page 236
- Eli Lilly adopt a risky stragtegy for enzastaurin in BCL - page 236
- Eli Lilly - page 237
- Cephalon's Lestaurtinib (CEP-701) - page 237
- Drug Profile - page 237
- Clinical Trial Data - page 238
- Datamonitor Comments - page 239
- Lestaurtinib may be the first in its class to reach the market - page 239
- Cephalon's recent acquisition of Trisenox will provide invaluable experience of the leukemia market - page 240
- Forecasts - page 240
- Datamonitor drug assessment summary - page 243
- CHAPTER 9 PIPELINE CELL CYCLE AND APOPTOSIS TARGETED AGENTS ANALYSIS & FORECASTS - page 247
- Pipeline overview - page 247
- Genta's Genasense (Oblimersen) - page 252
- Drug Profile - page 252
- Despite termination of Genta's agreement with Sanofi-Aventis, Genasense remains in development for a multitude of indications - page 252
- Clinical Trial Data - page 252
- Benefits of Genasense in CLL may not be enough to offset the addition of significant toxicity - page 253
- Long-term survival results of Genasense in malignant melanoma are of significance - page 255
- Disappointing Phase III trial results in multiple myeloma means status of further development is unclear - page 256
- Early-phase benefits of Genasense in AML require confirmation in Phase III clinical trial - page 257
- Promise shown in combination with rituximab in NHL, but randomized trials have yet to be initiated - page 258
- Lack of clinical data in NSCLC makes it difficult to judge Genasense's potential - page 259
- Encouraging Phase II results in prostate cancer, though Phase III trials have yet to be initiated - page 259
- Ongoing Phase II trial in SCLC will determine if patient benefit counters additional toxicity - page 259
- Genasense did not enhance activity of standard interferon-alfa in RCC - page 260
- Other trials - page 260
- Datamonitor Comments - page 260
- Approval of Genasense is looking increasingly unlikely - page 260
- Termination of agreement with Sanofi-Aventis is a major setback for Genta - page 262
- Drug Profile - page 252
- Telik's Telcyta (TLK286) - page 262
- Drug Profile - page 262
- Telcyta: a small molecule prodrug with dual antitumor activity developed using Telcyta's TRAP technology - page 262
- Clinical Trial Data - page 263
- Telcyta has Fast Track status for both NSCLC and Ovarian cancer - page 264
- Telcyta in NSCLC - page 264
- Telcyta in ovarian cancer - page 267
- Telcyta shows some activity as a single agent in breast cancer, although final Phase II results have yet to be published - page 269
- Datamonitor Comments - page 269
- Telik was unfortunate to use Iressa as a comparator in Telcyta's ASSIST-2 trial - page 269
- Penetrating the second- and third-line ovarian cancer market - page 270
- Without a partner, Telik will struggle to commercialize Telcyta - page 271
- Drug Profile - page 262
- Celtic Pharma/Xenova's TransMID (XR-311) - page 271
- Drug Profile - page 272
- TransMID's target is highly relevant in glioma - page 272
- Clinical Trial Data - page 273
- Encouraging Phase II results, active clinical trial program and Fast Track designation will drive development of TransMID - page 273
- Datamonitor Comments - page 274
- Cumbersome infusion schedule and administration may detract from TransMID's broad clinical benefit - page 274
- Although Xenova has secured several marketing partnerships, a glaring omission is one in the lucrative US market - page 275
- Drug Profile - page 272
- Sanofi-Aventis's Alvocidib (Flavopiridol) - page 275
- Drug Profile - page 275
- Clinical Trial Data - page 276
- Continuous infusion dosing schedules fail to demonstrate clinical activity - page 278
- Modified dosing regimen drives further development in CLL - page 278
- Alvocidib proves ineffective in hepatocellular carcinoma - page 279
- Initiation of a Phase II trial involving alvocidib in pancreatic cancer - page 279
- Datamonitor Comments - page 279
- Alvocidib's checkered history leaves KOLs cynical about its future clinical potential - page 279
- Alvocidib may show more promise as part of a combination regimen - page 280
- Presence in oncology field will aid commercialization of alvocidib - page 280
- Novogen's Phenoxodiol - page 281
- Drug Profile - page 281
- Clinical Trial Data - page 281
- Phenoxodiol's Fast Track status in Ovarian Cancer - page 282
- The OVATURE trials - page 282
- Initiation of a Phase I/II trial for Phenoxodiol plus Taxotere in ovarian cancer - page 283
- Phenoxodiol in Phase I for a variety of solid tumors - page 283
- Datamonitor Comments - page 284
- Toxicity will be the key factor for phenoxodiol's success - page 284
- Sanofi-Aventis as a marketing partner? - page 284
- Forecasts - page 285
- Datamonitor drug assessment summary - page 287
- CHAPTER 10 PIPELINE EPIGENETIC MODULATORS ANALYSIS & FORECASTS - page 291
- Pipeline overview - page 291
- Merck's Zolinza (Vorinostat, SAHA) - page 293
- Drug Profile - page 293
- Clinical Trial Data - page 293
- Zolinza granted Priority Review for CTCL following promising Phase IIb results - page 295
- FDA granted Orphan Drug designation for multiple myeloma - page 296
- Zolinza in Phase III trial for malignant pleural mesothelioma - page 296
- Other clinical trials - page 297
- Datamonitor Comments - page 297
- Zolinza will serve to increase Merck's oncology portfolio - page 297
- Merck conscious to not limit the use of Zolinza to just CTCL and myeloma - page 298
- Zolinza may face competition from Gloucester Pharmaceuticals' romidepsin - page 298
- Gloucester Pharmaceuticals' Romidepsin (FK-228, depsipeptide) - page 299
- Drug Profile - page 299
- Broad range of HDAC inhibition should theoretically provide increased efficacy - page 299
- Clinical Trial Data - page 299
- Romidepsin has fast track status and orphan drug status for CTCL - page 300
- Encouraging results in CTCL require replication in a Phase III clinical trial - page 300
- Romidepsin also showing promise in PTCL - page 301
- Romidepsin in Phase II for HRPC despite lack of preclinical evidence for this indication - page 301
- Datamonitor Comments - page 302
- Romidepsin may have difficulty competing with Merck's Zolinza in the CTCL market - page 302
- Further evaluation is needed to establish the clinical activity of combination therapy using HDAC inhibitors with cytotoxic drugs - page 302
- Commercial success of romidepsin will rely on Gloucester Pharmaceuticals collaborating with large pharma - page 303
- Drug Profile - page 299
- Forecasts - page 303
- Datamonitor drug assessment summary - page 305
- CHAPTER 11 PIPELINE IMMUNOMODULATORY AND IMMUNOCONJUGATED THERAPEUTICS ANALYSIS & FORECASTS - page 307
- Pipeline overview - page 307
- Wilex's Rencarex (WX-G250) - page 311
- Drug Profile - page 311
- MN/CA IX Antigen - A Highly Specific Tumor Target - page 311
- Mode of Action of Rencarex - ADCC - page 311
- Clinical Trial Data - page 312
- Rencarex in Phase III for non-metastatic RCC (the ARISER trial) - page 312
- Completed Phase I & II trials for metastatic RCC - page 312
- Datamonitor Comments - page 315
- Rencarex may face a number of hurdles - page 315
- Drug Profile - page 311
- Genmab's Ofatumumab (HuMax-CD20) - page 316
- Drug Profile - page 316
- Clinical Trial Data - page 317
- Genmab hoping ofatumumab will demonstrate a preferred efficacy profile over Rituxan in the clinic - page 317
- Ofatumumab receives fast track status for CLL and enters a Phase III trial - page 318
- Genmab initiate a pivotal trial in NHL - page 319
- Datamonitor Comments - page 320
- Genmab should look to compare ofatumumab with Rituxan in a Phase III trial - page 320
- Commercial success of ofatumumab will rely on Genmab collaborating with large pharma - page 321
- Forecasts - page 321
- Datamonitor drug assessment summary - page 323
- CHAPTER 12 COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT: CASE STUDIES - page 325
- Introduction - page 325
- Case study one - page 325
- Clinical, developmental and commercial challenges to combining molecular targeted therapies - page 325
- How to optimally utilize molecular targeted therapies in the context of combinatorial regimens - page 325
- Intellectual property implications associated with combining targeted therapies - page 327
- Lessons to be learnt from already marketed targeted therapies - page 328
- Differences and similarities between monoclonal antibodes and small molecules - page 331
- Effectively demonstrating the clinical and pharmacoeconomic value of combinatorial MTT strategies is critical - page 333
- Clinical, developmental and commercial challenges to combining molecular targeted therapies - page 325
- Case study two - page 339
- Comparing marketed and pipeline MTTs: The evolving trends - page 339
- Segmentation of MTTs by structural class - page 341
- Segmentation of MTTs by indication - page 343
- Approval paths experienced by the marketed MTTs - page 349
- Developing a targeted therapy for a niche tumor over one of the 'big four' tumor types - Which strategy should Pharma pursue? - page 351
- Comparing marketed and pipeline MTTs: The evolving trends - page 339
- APPENDIX A - MARKET DATA & MAJOR BRAND KEY FACTS - page 355
- L1X3 (antineoplastic monoclonal antibodies) class market data - page 355
- L1X9 (all other neoplastics) class market data - page 360
- Sales data and forecasts - page 364
- PowerPoint Executive Presentation - page 364
- APPENDIX B - SALES FORECASTS - page 365
- US Forecasts - page 365
- Japan Forecasts - page 366
- France Forecasts - page 367
- Germany Forecasts - page 368
- Italy Forecasts - page 369
- Spain Forecasts - page 370
- UK Forecasts - page 371
- Five Major European Markets (EU5) Forecasts - page 372
- Seven Major Markets Forecasts - page 373
- APPENDIX C - page 374
- List of Tables
- List of Figures
- Methodology - page 376
- Datamonitor forecast methodology - page 376
- Forecasts for marketed drugs - page 376
- Forecasts for pipeline drugs - page 377
- Datamonitor drug assessment methodology - page 378
- Datamonitor forecast methodology - page 376
- Abbreviations - page 381
- Contributing experts - page 383
- Bibliography - page 383
- About Datamonitor - page 407
- About Datamonitor Healthcare - page 407
- About the Oncology analysis team - page 408
- Disclaimer - page 409
- List of Tables
- Table 1: Molecular targeted therapies in preregistration, 2006 - page 11
- Table 2: Molecular targeted therapies in Phase III development, 2006 - page 12
- Table 3: Pipeline molecular targeted therapies by development phase and class of drug, 2006 - page 14
- Table 4: Pipeline molecular targeted therapies by indication, 2006 - page 21
- Table 5: Specific target/targets with two candidates in the pipeline, 2006 - page 24
- Table 6: Specific target/targets with three or more candidates in the pipeline, 2006 - page 25
- Table 7: Number of products in the pipeline targeting key molecular drivers of cancer, 2006 - page 26
- Table 8: Companies with two candidates in the molecular targeted therapies pipeline, 2006 - page 28
- Table 9: Companies with three candidates in the molecular targeted therapies pipeline, 2006 - page 29
- Table 10: Companies with four or more candidates in the molecular targeted therapies pipeline, 2006 - page 29
- Table 11: Pfizer's marketed oncology portfolio, 2006 - page 31
- Table 12: Pfizer's molecular targeted cancer therapies portfolio, 2006 - page 31
- Table 13: Novartis' marketed oncology portfolio, 2006 - page 32
- Table 14: Novartis' molecular targeted cancer therapies portfolio, 2006 - page 33
- Table 15: GSK's marketed oncology portfolio, 2006 - page 35
- Table 16: GSK's molecular targeted cancer therapies portfolio, 2006 - page 35
- Table 17: Late-phase pipeline targeted therapies sales forecasts for the seven major markets ($m), 2006-2015 - page 37
- Table 18: Datamonitor drug assessment summary for late-phase pipeline molecular targeted cancer therapies, 2006 - page 44
- Table 19: Common mutations involved in tumor development - page 52
- Table 20: Forecast incidence of cancer across the seven major markets, 2005-2013 - page 58
- Table 21: Examples of naturally occurring angiogenesis stimulators - page 75
- Table 22: Recently approved multi-targeted inhibitors, 2006 - page 79
- Table 23: Current targeted therapy marketed products, 2006 (1 of 2) - page 84
- Table 24: Current targeted therapy marketed products, 2006 (1 of 2) - page 85
- Table 25: Targeted therapies sales in the seven major markets, 2005 - page 86
- Table 26: Clinical pipeline for Nexavar, 2006 - page 106
- Table 27: Clinical pipeline for Sprycel, 2006 - page 108
- Table 28: Summary of Phase II Sprycel clinical trial results - page 109
- Table 29: Clinical pipeline for Sutent, 2006 - page 110
- Table 30: Approved indications for Rituxan in the US and EU, 2006 - page 119
- Table 31: Late-phase pipeline angiogenesis inhibitors, 2006 - page 122
- Table 32: Phase II pipeline angiogenesis inhibitors, 2006 - page 123
- Table 33: Phase I pipeline angiogenesis inhibitors, 2006 - page 124
- Table 34: Ongoing clinical trials involving AZD2171, 2006 - page 126
- Table 35: Ongoing clinical trials involving pazopanib, 2006 - page 132
- Table 36: Ongoing clinical trials involving vatalanib, 2006 - page 136
- Table 37: Ongoing clinical trials involving VEGF-Trap, 2006 - page 142
- Table 38: Forecasting assumptions for late-phase angiogenesis inhibitors, 2006 - page 147
- Table 39: Angiogenesis inhibitors sales forecasts ($m), 2006-2015 - page 148
- Table 40: Research/clinical and commercial attractiveness of pipeline angiogenesis inhibitors, 2006 - page 149
- Table 41: Late-phase pipeline single-target signal transduction inhibitors, 2006 - page 152
- Table 42: Phase II pipeline single-target signal transduction inhibitors, 2006 - page 153
- Table 43: Phase I pipeline single-target signal transduction inhibitors, 2006 - page 154
- Table 44: Ongoing clinical trials involving Vectibix, 2006 - page 156
- Table 45: Ongoing clinical trials involving Sarasar, 2006 - page 164
- Table 46: Ongoing clinical trials involving Xinlay, 2006 - page 170
- Table 47: Historical development of Xinlay, 1994-2005 - page 172
- Table 48: Ongoing Phase II/III trials involving temsirolimus, 2006 - page 174
- Table 49: Ongoing clinical trials involving Zarnestra, 2006 - page 180
- Table 50: Phase I/II trial involving Nexavar, Tarceva, Torisel and Zarnestra, 2006 - page 186
- Table 51: Forecasting assumptions for late-stage pipeline single-target signal transduction inhibitors (1 of 2) - page 193
- Table 52: Forecasting assumptions for late-stage pipeline single-target signal transduction inhibitors (2 of 2) - page 194
- Table 53: Single-target signal transduction inhibitors sales forecasts ($m), 2006-2015 - page 194
- Table 54: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors (1 of 2) - page 197
- Table 55: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors (2 of 2) - page 197
- Table 56: Late-phase pipeline multi-targeted inhibitors, 2006 - page 199
- Table 57: Phase II pipeline multi-targeted inhibitors, 2006 - page 200
- Table 58: Phase I pipeline multi-targeted inhibitors, 2006 - page 201
- Table 59: Ongoing breast cancer clinical trials involving Tykerb, 2006 - page 203
- Table 60: Ongoing non-breast cancer clinical trials involving Tykerb, 2006 - page 204
- Table 61: Summary of key Tykerb breast cancer clinical trials, 2006 - page 206
- Table 62: Ongoing clinical trials involving Ceflatonin, 2006 - page 217
- Table 63: Ongoing trials involving Somatuline, 2006 - page 219
- Table 64: Ongoing clinical trials involving Tasigna, 2006 - page 222
- Table 65: Zactima's multiple anticancer targets - page 226
- Table 66: Ongoing clinical trials involving Zactima - page 226
- Table 67: Ongoing clinical trials involving enzastaurin, 2006 - page 233
- Table 68: Ongoing clinical trials involving lestaurtinib - page 238
- Table 69: Forecasting assumptions for late-stage pipeline multi-targeted inhibitors (1 of 2) - page 241
- Table 70: Forecasting assumptions for late-stage pipeline multi-targeted inhibitors (2 of 2) - page 241
- Table 71: Multi-targeted inhibitors sales forecasts ($m), 2006-2015 - page 242
- Table 72: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors (1 of 2) - page 244
- Table 73: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors (2 of 2) - page 244
- Table 74: Late-phase pipeline cell cycle and apoptosis targeted agents, 2006 - page 247
- Table 75: Phase II pipeline cell cycle and apoptosis targeted agents, 2006 - page 248
- Table 76: Phase I pipeline cell cycle and apoptosis targeted agents, 2006 - page 250
- Table 77: Ongoing clinical trials involving Genasense, 2006 - page 253
- Table 78: Ongoing clinical trials involving Telcyta, 2006 - page 264
- Table 79: NSCLC clinical trial data summary for Telcyta, 2006 - page 265
- Table 80: Key Phase III trials of Telcyta for ovarian cancer, 2006 - page 267
- Table 81: Ongoing clinical trials involving TransMID, 2006 - page 273
- Table 82: Ongoing clinical trials involving alvocidib, 2006 - page 277
- Table 83: Ongoing clinical trials involving phenoxodiol, 2006 - page 281
- Table 84: Forecasting assumptions for late-stage pipeline cell cycle and apoptosis targeted agents (1 of 2) - page 285
- Table 85: Forecasting assumptions for late-stage pipeline cell cycle and apoptosis targeted agents (2 of 2) - page 285
- Table 86: Cell cycle and apoptosis targeted agents sales forecasts ($m), 2006-2015 - page 286
- Table 87: Research/clinical and commercial attractiveness of pipeline cell cycle and apoptosis targeted agents - page 288
- Table 88: Late-phase pipeline epigenetic modulators, 2006 - page 291
- Table 89: Phase II pipeline epigenetic modulators, 2006 - page 291
- Table 90: Phase I pipeline epigenetic modulators, 2006 - page 292
- Table 91: Ongoing clinical trials involving Zolinza, 2006 - page 293
- Table 92: Ongoing clinical trials involving romidepsin, 2006 - page 300
- Table 93: Zolinza forecasting assumptions - page 303
- Table 94: Zolinza sales forecasts ($m), 2006-2015 - page 304
- Table 95: Research/clinical and commercial attractiveness of Zolinza - page 305
- Table 96: Late-phase pipeline immunomodulatory and immunoconjugated therapeutics, 2006 - page 307
- Table 97: Phase II pipeline immunomodulatory and immunoconjugated therapeutics, 2006 - page 307
- Table 98: Phase I pipeline immunomodulatory and immunoconjugated therapeutics, 2006 - page 309
- Table 99: Ongoing clinical trial involving Rencarex, 2006 - page 312
- Table 100: Ongoing clinical trial involving ofatumumab, 2006 - page 317
- Table 101: Forecasting assumptions for late-phase immunomodulatory and immunoconjugated therapeutics - page 321
- Table 102: Late-phase immunomodulatory and immunoconjugated therapeutics sales forecasts ($m), 2006-2015 - page 322
- Table 103: Research/clinical and commercial attractiveness of the late-phase immunomodulatory and immunoconjugated therapeutics - page 323
- Table 104: Phase I/II trial involving Nexavar, Tarceva, Torisel and Zarnestra in GBM or gliosarcoma patients, 2006 - page 326
- Table 105: Examples of combinatorial approaches of MAbs with chemotherapy - page 329
- Table 106: Comparative characteristics of small molecules and MAbs - page 332
- Table 107: Single agents versus multiple agents in combination - page 334
- Table 108: Marketed molecular targeted cancer therapies, 2006 - page 340
- Table 109: Rituxan: key facts - page 355
- Table 110: Herceptin: key facts - page 356
- Table 111: Campath: key facts - page 356
- Table 112: Mylotarg: key facts - page 357
- Table 113: Bexxar: key facts - page 357
- Table 114: Avastin: key facts - page 358
- Table 115: Erbitux: key facts - page 358
- Table 116: Zevalin: key facts - page 359
- Table 117: Gleevec: key facts - page 360
- Table 118: Targretin: key facts - page 360
- Table 119: Iressa: key facts - page 361
- Table 120: Velcade: key facts - page 361
- Table 121: Tarceva: key facts - page 362
- Table 122: Sprycel: key facts - page 362
- Table 123: Nexavar: key facts - page 363
- Table 124: Sutent: key facts - page 363
- Table 125: Ontak: key facts - page 364
- Table 126: Forecasts for marketed targeted therapies for the US ($m), 2005-2015 - page 365
- Table 127: Forecasts for marketed targeted therapies for Japan ($m), 2005-2015 - page 366
- Table 128: Forecasts for marketed targeted therapies for France ($m), 2005-2015 - page 367
- Table 129: Forecasts for marketed targeted therapies for Germany ($m), 2005-15 - page 368
- Table 130: Forecasts for marketed targeted therapies for Italy ($m), 2005-15 - page 369
- Table 131: Forecasts for marketed targeted therapies for Spain ($m), 2005-15 - page 370
- Table 132: Forecasts for marketed targeted therapies in the UK ($m), 2005-15 - page 371
- Table 133: Forecasts for marketed targeted therapies for the EU5 ($m), 2005-2015 - page 372
- Table 134: Forecasts for marketed targeted therapies for the seven major markets ($m), 2005-2015 - page 373
- Table 135: Datamonitor drug assessment parameters - page 378
- Table 136: Abbreviations used in Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies (1 of 2) - page 381
- Table 137: Abbreviations used in Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies (2 of 2) - page 382
- List of Figures
- Figure 1: Pipeline molecular targeted therapies by development phase and class of drug, 2006 - page 15
- Figure 2: Pipeline molecular targeted therapies by class of drug, 2006 - page 16
- Figure 3: Pipeline molecular targeted therapies by development phase, 2006 - page 17
- Figure 4: Angiogenesis inhibitors by developmental phase, 2006 - page 18
- Figure 5: Single-target signal transduction inhibitors by developmental phase, 2006 - page 18
- Figure 6: Multi-targeted inhibitors by developmental phase, 2006 - page 19
- Figure 7: Cell cycle and apoptosis targeted agents by developmental phase, 2006 - page 19
- Figure 8: Epigenetic inhibitors by developmental phase, 2006 - page 20
- Figure 9: Immunomodulatory and immunoconjugated therapeutics by developmental phase, 2006 - page 20
- Figure 10: Pipeline molecular targeted therapies by solid tumor indication, 2006 - page 22
- Figure 11: Pipeline molecular targeted therapies by hematological malignancy, 2006 - page 23
- Figure 12: Number of products in the pipeline targeting key molecular drivers of cancer, 2006 - page 27
- Figure 13: Companies with four or more candidates in the molecular targeted therapies pipeline, 2006 - page 30
- Figure 14: Pipeline angiogenesis inhibitors sales forecasts for the seven major markets ($m), 2006-2015 - page 38
- Figure 15: Pipeline single-target signal transduction inhibitors sales forecasts for the seven major markets ($m), 2006-2015 - page 39
- Figure 16: Pipeline multi-targeted inhibitors sales forecasts for the seven major markets ($m), 2006-2015 - page 40
- Figure 17: Pipeline cell cycle and apoptosis targeted agents sales forecasts for the seven major markets ($m), 2006-2015 - page 41
- Figure 18: Pipeline epigenetic modulators sales forecasts for the seven major markets ($m), 2006-2015 - page 42
- Figure 19: Pipeline immunomodulatory and immunoconjugated therapeutics sales forecasts for the seven major markets ($m), 2006-2015 - page 43
- Figure 20: Datamonitor drug assessment summary for pipeline angiogenesis inhibitors, 2006 - page 45
- Figure 21: Datamonitor drug assessment summary for pipeline single-target signal transduction inhibitors, 2006 - page 46
- Figure 22: Datamonitor drug assessment summary for pipeline multi-targeted inhibitors, 2006 - page 47
- Figure 23: Datamonitor drug assessment summary for pipeline cell cycle and apoptosis targeted agents, 2006 - page 48
- Figure 24: Datamonitor drug assessment summary for epigenetic modulators, 2006 - page 49
- Figure 25: Datamonitor drug assessment summary for immunomodulatory and immunoconjugated therapeutics, 2006 - page 50
- Figure 26: Global oncology sales ($m), 2002-09 - page 56
- Figure 27: Oncology pipeline including supportive care, 2006 - page 57
- Figure 28: Forecast incidence of cancer across the seven major markets, 2005-2013 - page 59
- Figure 29: Combined incidence for breast, lung, prostate and colorectal cancer rises with age in seven major markets, 2003 - page 60
- Figure 30: Incidence increases, while the rate of cure and death reduces disease prevalence - page 61
- Figure 31: Point prevalence for colorectal and lung cancer differs markedly despite similar rates of incidence - page 62
- Figure 32: Unmet needs in cancer, 2006 - page 66
- Figure 33: The process of tumor angiogenesis - page 74
- Figure 34: Approaches to inhibition of VEGF signaling - page 126
- Figure 35: Angiogenesis inhibitors sales forecasts ($m), 2006-2015 - page 148
- Figure 36: Research/clinical and commercial attractiveness of pipeline angiogenesis inhibitors, 2006 - page 150
- Figure 37: Single-target signal transduction inhibitors sales forecasts ($m), 2006-2015 - page 195
- Figure 38: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors, 2006 - page 198
- Figure 39: Design of Phase III Tykerb plus capecitabine versus capecitabine alone trial - page 208
- Figure 40: Multi-targeted inhibitors sales forecasts ($m), 2006-2015 - page 242
- Figure 41: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors - page 245
- Figure 42: Telcyta's mechanism of action - page 263
- Figure 43: TransMID's mode of action - page 272
- Figure 44: Cell cycle and apoptosis targeted agents sales forecasts ($m), 2006-2015 - page 286
- Figure 45: Research/clinical and commercial attractiveness of pipeline cell cycle and apoptosis targeted agents - page 289
- Figure 46: Zolinza sales forecasts ($m), 2006-2015 - page 304
- Figure 47: Research/clinical and commercial attractiveness of Zolinza - page 306
- Figure 48: Rencarex induced ADCC - page 311
- Figure 49: Rencarex Phase II results: median survival - page 314
- Figure 50: Late-phase immunomodulatory and immunoconjugated therapeutics sales forecasts ($m), 2006-2015 - page 322
- Figure 51: Research/clinical and commercial attractiveness of the late-phase immunomodulatory and immunoconjugated therapeutics, 2006 - page 324
- Figure 52: Number of marketed MAbs and small molecules, 2006 - page 341
- Figure 53: Number of late-phase MAbs and small molecules, 2006 - page 342
- Figure 54: Number of marketed molecular targeted therapies for solid tumors and hematological malignancies, 2006 - page 343
- Figure 55: Number of late-phase molecular targeted therapies for solid tumors and hematological malignancies, 2006 - page 344
- Figure 56: Number of molecular targeted therapies approved in the 'big four' tumor types, 2006 - page 345
- Figure 57: Number of late-phase molecular targeted therapies in the 'big four' tumor types, 2006 - page 346
- Figure 58: Marketed molecular targeted therapies by indication, 2006 - page 348
- Figure 59: Phase I, II and III molecular targeted therapies by indication, 2006 - page 349
- Figure 60: Approval paths of the marketed molecular targeted therapies - page 350
- Figure 61: Advantages and disadvantages of developing an MTT in one of the 'Big Four' tumor types - page 352
- Figure 62: Advantages and disadvantages of developing an MTT in a niche tumor type - page 353
- Figure 63: Example of Datamonitor drug assessment scorecard - page 379
- Figure 64: Example of Datamonitor drug assessment graph - page 380
Other users found this report page using the following search terms: targeted therapy Rituxan Herceptin Avastin gleevec laptinib sorafinib kinase vorinostat hdac ppt cancer targeted molecular therapy market drugs therapies drug action
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.
Refund and Cancellation Policy: The descriptions of the products and services sold on LeadDiscovery.co.uk are as complete and accurate as possible, and customers are encouraged to read all available information about a product before placing an order. Due to the nature of the information being sold, orders for reports cannot be canceled.