Pipeline Insight: Cancer Overview - Lung, Brain, Head and Neck, Thyroid
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the cancer market 3
Contributing experts 5
Related reports 5
Upcoming reports 6
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS 8
Pipeline overview 8
Late-phase pipeline 8
Pipeline by indication 11
The higher-incidence tumor types remain the most popular indications for drug
development 11
CHAPTER 3 R&D APPROACH 12
Classification of pipeline products 12
Cytotoxics 12
Antihormonal therapies 13
Molecular targeted therapies 14
Single-target signal transduction inhibitors 15
Angiogenesis inhibitors 15
Apoptosis inducers 16
Cell cycle inhibitors 16
Multi-targeted inhibitors 17
Epigenetic modulators 17
Immunotherapeutic agents 17
CHAPTER 4 NON-SMALL CELL LUNG CANCER 19
Overview of NSCLC 19
Definition 19
NSCLC accounts for about 80% of all lung cancers 19
Epidemiology 19
There will be more than 380,000 new cases of NSCLC in the seven major markets in
2017 19
Mortality from NSCLC is high 20
Treatment of NSCLC 21
Unmet needs in NSCLC 22
Summary of unmet needs 22
Effective treatments are required for both advanced and early-stage disease 23
NSCLC needs to be recognized as a heterogeneous disease 24
Less toxic treatments for poor performance status patients are required 25
The treatment of NSCLC is in need of overall refinement 25
Pipeline overview 25
Pipeline summary 25
Late-phase pipeline 28
Phase II pipeline 30
Comparative forecasts 35
Definition of current comparator therapy 42
Pipeline candidates 44
Erbitux (cetuximab; ImClone/Merck Serono/Bristol-Myers Squibb) 44
Drug overview 44
Key historical events 44
Clinical development in NSCLC 46
Datamonitor comments 50
Nexavar (sorafenib; Bayer Schering) 53
Drug overview 53
Key historical events 53
Clinical development in NSCLC 54
Datamonitor comments 59
Sutent (sunitinib; Pfizer) 61
Drug overview 61
Key historical events 61
Clinical development in NSCLC 62
Datamonitor comments 64
Tovok (BIBW 2992; Boehringer Ingelheim) 66
Drug overview 66
Key historical events 66
Clinical development in NSCLC 66
Datamonitor comments 68
Vargatef (BIBF 1120; Boehringer-Ingelheim) 69
Drug overview 69
Key historical events 70
Clinical development in NSCLC 70
Datamonitor comments 71
Zactima (vandetanib; AstraZeneca) 72
Drug overview 72
Key historical events 72
Clinical development in NSCLC 73
Datamonitor comments 77
Zolinza (vorinostat; Merck & Co) 80
Drug overview 80
Key historical events 80
Clinical development in NSCLC 80
Datamonitor comments 83
Aflibercept (VEGF-Trap; Sanofi-Aventis/Regeneron) 83
Drug overview 83
Key historical events 84
Clinical development in NSCLC 84
Datamonitor comments 86
ASA-404 (Antisoma/Novartis) 88
Drug overview 88
Key historical events 88
Clinical development in NSCLC 88
Datamonitor comments 91
CBT-1 (CBA Pharma) 92
Drug overview 92
Key historical events 92
Clinical development in NSCLC 93
Datamonitor comments 93
CP-751871 (Pfizer) 93
Drug overview 93
Key historical events 94
Clinical development in NSCLC 94
Datamonitor comments 95
Motesanib (AMG706; Amgen/Takeda Pharmaceutical) 96
Drug overview 96
Key historical events 96
Clinical development in NSCLC 96
Datamonitor comments 98
Abraxane (albumin-bound paclitaxel; Abraxis) 99
Drug overview 99
Key historical events 100
Clinical development in NSCLC 101
Datamonitor comments 103
Glutoxim (NOV-002; Novelos) 105
Drug overview 105
Key historical events 105
Clinical development in NSCLC 106
Datamonitor comments 107
Javlor (vinflunine; Pierre Fabre) 108
Drug overview 108
Key historical events 108
Clinical development in NSCLC 108
Datamonitor comments 111
Lipoplatin (liposomal cisplatin; Regulon) 112
Drug overview 112
Key historical events 112
Clinical development in NSCLC 113
Datamonitor comments 116
Taxoprexin (DHA paclitaxel; Luitpold) 116
Drug overview 116
Key historical events 117
Clinical development in NSCLC 117
Datamonitor comments 118
Opaxio (paclitaxel polyglumex; Cell Therapeutics/Novartis) 119
Drug overview 119
Key historical events 119
Clinical development in NSCLC 120
Datamonitor comments 124
Lucanix (NovaRx) 125
Drug overview 125
Key historical events 125
Clinical development in NSCLC 125
Datamonitor comments 127
Stimuvax (BLP-25; Merck Serono) 128
Drug overview 128
Key historical events 129
Clinical development in NSCLC 129
Datamonitor comments 131
MAGE-A3 ASCI (GSK1572932A; GlaxoSmithKline) 132
Drug overview 132
Key historical events 133
Clinical development in NSCLC 133
Datamonitor comments 134
Satisfaction of unmet needs 136
Approval of pipeline drugs will offer alternative treatment options, however,
are unlikely to significantly fulfil unmet needs 136
CHAPTER 5 SMALL CELL LUNG CANCER 137
Overview of SCLC 137
Definition 137
Epidemiology 138
The incidence of SCLC is decreasing with declining smoking prevalence 138
Poor survival rates result in a high mortality from SCLC 139
Treatment of SCLC 140
Unmet needs in SCLC 141
Summary of unmet needs 141
There is a need for more effective systemic therapies to improve patient
survival 142
R&D activity in the field must be intensified 143
A better understanding of the molecular basis of the disease may help in the
development of novel targeted agents 144
Pipeline overview 144
Pipeline summary 144
Late-phase pipeline 145
Phase II pipeline 146
Comparative forecasts 147
Definition of current comparator therapy 149
Pipeline candidates 150
Picoplatin (AMD-473; Poniard Pharmaceuticals) 150
Drug overview 150
Key historical events 150
Clinical development in SCLC 151
Datamonitor comments 153
Satisfaction of unmet needs 154
Picoplatin is unlikely to offer any significant improvements in terms of patient
survival 154
CHAPTER 6 MESOTHELIOMA 155
Overview of mesothelioma 155
Definition 155
Mesothelioma is almost always caused by sustained exposure to asbestos 155
Epidemiology 155
Forecast incidence is difficult to predict for mesothelioma, although the cancer
is relatively rare 155
Survival rates for mesothelioma have improved minimally over the years 157
Treatment of mesothelioma 157
Unmet need in mesothelioma 158
Summary of unmet needs 158
Increasing incidence and need for earlier diagnosis 159
Low rate of curative surgery 159
Lack of approved therapies and low R&D interest 159
Pipeline overview 160
Pipeline summary 160
Late-phase pipeline 160
Phase II pipeline 161
Comparative forecasts 162
Definition of current comparator therapy 163
Pipeline candidates 164
Onconase (Alfacell Corp; ranpirnase) 164
Drug overview 164
Key historical events 164
Clinical development in mesothelioma 164
Datamonitor comments 166
Zolinza (vorinostat; Merck & Co) 167
Drug overview 167
Key historical events 167
Clinical development in mesothelioma 167
Datamonitor comments 169
Satisfaction of unmet needs 169
Onconase and Zolinza meet some unmet needs in terms of providing much needed
alternative treatment options 169
CHAPTER 7 PRIMARY BRAIN CANCER 171
Overview of primary brain cancer 171
Definition 171
Glioma is the most common type of primary brain cancer 171
Epidemiology 171
Incidence of brain cancer is rising in line with the ageing population 171
Mortality from brain cancer is very high in comparison to its incidence 172
Treatment of primary brain cancer 173
Unmet need in primary brain cancer 174
Summary of unmet needs 174
More effective chemotherapy options needed 175
Blood-brain barrier may prove an obstacle to overcome 175
Need for neuroprotective therapy 176
Pipeline overview 176
Pipeline summary 176
Late-phase pipeline 177
Phase II pipeline 178
Comparative forecasts 180
Definition of current comparator therapy 182
Pipeline candidates 183
Theraloc (nimotuzumab; YM Biosciences/Biocon Biopharmaceuticals) 183
Drug overview 183
Key historical events 183
Clinical development in brain cancer 184
Datamonitor comments 185
Cerepro (sitimagene ceradenovec; Ark Therapeutics) 186
Drug overview 186
Key historical events 186
Clinical development in brain cancer 187
Datamonitor comments 189
Satisfaction of unmet needs 190
Temodar will retain its leading status for some time to come in the primary
brain cancer market 190
CHAPTER 8 HEAD AND NECK CANCER 191
Overview of head and neck cancer 191
Definition 191
Head and neck cancers comprise around 6% of all tumors worldwide 191
Epidemiology 192
Incidence will continue to rise in line with the ageing population 192
Mortality is high due to frequent late-stage diagnosis and lack of effective
treatments 192
Treatment of head and neck cancer 193
Unmet need in head and neck cancer 194
Summary of unmet needs 194
Currently available therapies induce modest response rates 195