Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Oncology pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of analysis
- Datamonitor insight into the molecular targeted therapies market
- Related reports
- Upcoming reports
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Late-phase pipeline molecular targeted cancer therapies
- Phase II pipeline molecular targeted cancer therapies
- Phase I pipeline molecular targeted cancer therapies
- Pipeline by developmental phase and class of drug
- There are 329 different MTTs in the clinical development pipeline
- The cell cycle and apoptosis targeted agents make up the largest
number of MTTs in the pipeline
- Segmentation of drugs by developmental phase reflects attrition rate
of drug development in the oncology market
- Targeted therapy remains a promising anticancer drug development
strategy
- Developmental agents by phase for each class
- Pipeline by indication
- Pipeline MTTs are being investigated in 29 different cancers
- The ' big four' tumor types are the most popular indications for
development
- Pipeline by mode of action
- Pipeline products are directed against a huge variety and combination
of molecular targets
- The VEGF/VEGFR family remains the focus of development for MTTs
- Pipeline by company
- There are 175 different companies developing targeted therapies
- Developmental pipeline dominated by small pharma/biotech players
- There are 19 companies with MTT products in late-phase development
- Top three companies in terms of number of pipeline MTT products are
Pfizer, AstraZeneca and Novartis
- Pfizer - 21 MTT pipeline products
- AstraZeneca - 15 MTT pipeline products
- Novartis - 12 MTT pipeline products
- Key metrics
- Datamonitor pipeline assessment summary
- CHAPTER 3 CURRENT MARKET STATUS & PIPELINE CLASSIFICATION
- Targeted therapies overview
- The development of molecular targeted therapies
- Current therapies are less cancer cell-specific
- The strategy is to target the specific survival factors of a tumor
- Key issue is the identification of targets unique to cancer cells
- Market definition
- L1X3 - Antineoplastic monoclonal antibodies
- L1X9 - All other antineoplastics
- Current market status
- Classification of pipeline products
- Angiogenesis inhibitors
- Angiogenesis as a normal biological process
- Angiogenesis is known to be aberrant in tumor cell proliferation
- Angiogenesis inhibitors as viable antitumor agents can target a
number of pathways
- At present, only one angiogenesis inhibitor exists on the market
- Single-target signal transduction inhibitors
- A plethora of potential targets exist along the signaling cascade
- Several signal transduction inhibitors have reached the market,
bringing with them their own sets of issues for consideration
- Multi-targeted inhibitors
- Multi-targeted inhibitors have certain advantages over single
targeted agents
- Approval of three multi-targeted inhibitors
- Cell cycle and apoptosis targeted inhibitors
- Only one cell cycle inhibitor has entered Phase III
- Cell death can be induced via a number of different pathways
- To date, only one apoptosis stimulator has reached the market
- Epigenetic modulators
- Despite relative immaturity of development in this class of drugs,
the potential to enhance current therapies exists
- Immunomodulatory and immunoconjugated therapeutics
- Antibody-based technologies are an effective anticancer approach
- Oncology clinical trial design
- Patient selection
- Increasingly significant in the era of targeted treatment
- Clinical trial duration
- Sufficient follow-up is necessary to establish true clinical benefit
- The advent of novel therapies
- Diversity of targeted therapies will require an evolution in
clinical trial design
- Clinical trial endpoints in oncology
- Most oncology clinical trials designate multiple endpoints
- Survival
- Quality of life
- Tumor response rates
- Toxicity
- Time to tumor progression
- CHAPTER 4 PIPELINE ANGIOGENESIS INHIBITORS ANALYSIS & FORECASTS
- Overview of angiogenesis inhibitors
- Pipeline summary
- Late-phase pipeline of angiogenesis inhibitors
- Phase II pipeline of angiogenesis inhibitors
- Phase I pipeline of angiogenesis inhibitors
- Comparative forecasts
- Definition of current comparator therapy
- Avastin (Bevacizumab; Genentech/Roche/Chugai)
- Aflibercept (VEGF-Trap; Sanofi Aventis/Regeneron)
- Drug overview
- Key historical events
- Clinical trial data
- Interim Phase II results for aflibercept in ovarian cancer
- Interim Phase II results for aflibercept in NSCLC
- Aflibercept demonstrates similar side effects to Avastin
- Datamonitor comments
- Fierce competition with Avastin in the wider cancer market
- Presence in oncology field will aid commercialization of aflibercept
- Forecasts to 2016
- Datamonitor drug assessment summary
- Pazopanib (GW786034; GlaxoSmithKline)
- Drug overview
- Key historical events
- Clinical trial data
- Pazopanib as a possible second-line monotherapy treatment for
metastatic RCC
- Co-administration with Tykerb may alter the pharmacokinetics of
pazopanib - Phase III studies planned
- Pazopanib showing applicability across a broad range of solid tumor
types
- Datamonitor comments
- Initial approval in RCC will force pazopanib to compete against the
already approved Sutent and Nexavar
- Extensive parallel development program planned
- Tykerb may well enhance the success of pazopanib but at what price?
- Forecasts to 2016
- Datamonitor drug assessment summary
- Recentin (Cediranib, AZD2171; AstraZeneca)
- Drug overview
- Key historical events
- Clinical trial data
- AstraZeneca targets first-line CRC
- Recentin has potential in NSCLC in combination with standard
chemotherapy regimens
- Phase III study planned for Recentin in glioma
- Datamonitor comments
- As a potentially more potent inhibitor of angiogenesis, and given
its formulation, Recentin' s future may be highly promising
- Phase III studies in CRC are high-risk while development in glioma
may offer a quicker route to market
- AstraZeneca' s strength in the oncology market will be key in
Recentin' s success
- Forecasts to 2016
- Datamonitor drug assessment summary
- CHAPTER 5 PIPELINE SINGLE-TARGET SIGNAL TRANSDUCTION INHIBITORS ANALYSIS
& FORECASTS
- Overview of single-target signal transduction inhibitors
- Pipeline summary
- Late-phase pipeline of single-target signal transduction inhibitors
- Phase II pipeline of single-target signal transduction inhibitors
- Phase I pipeline of single-target signal transduction inhibitors
- Comparative forecasts
- Definition of current comparator therapy
- Gleevec (Imatinib; Novartis)
- Certican (Everolimus, RAD-001; Novartis)
- Drug overview
- Key historical events
- Clinical trial data
- Certican may be a promising addition to the treatment of
neuroendocrine tumors
- Certican is also showing applicability in some of the more common
tumor types
- Datamonitor comments
- Approval as an anticancer therapy will enable Certican to achieve a
significantly higher level of sales
- NET a good place to start
- Novartis is an ideal backer for the drug
- Certican may face stiff competition from Torisel
- Forecasts to 2016
- Datamonitor drug assessment summary
- Sarasar (Lonafarnib; Schering-Plough)
- Drug overview
- Key historical events
- Clinical trial data
- Main focus of Sarasar is development in MDS, where greatest
antitumor activity is shown
- Farnesyl transferase inhibitors predominately in hematological
disorders
- Lack of efficacy has led to termination of pivotal Phase III trial
in NSCLC
- Lack of clinical data makes it difficult to judge Sarasar' s
potential in breast cancer
- Benefit shown in advanced head and neck cancer, although no further
trials have been announced
- Mild toxicity in the majority of patients, although grade 3 events
do occur
- Datamonitor comments
- Sarasar' s chances for approval will be delayed beyond 2007
- Sarasar racing against Johnson & Johnson' s Zarnestra as the
first farnesyl transferase inhibitor to reach the market
- Presence in oncology market will aid commercialization of Sarasar
- Forecasts to 2016
- Datamonitor drug assessment summary
- TheraCIM (Nimotuzumab; YM Bioscience)
- Drug overview
- Key historical events
- Clinical trial data
- Phase III underway for pediatric pontine (brain stem) glioma
- Phase II pediatric trial demonstrated activity
- Datamonitor comments
- Phase III trial results required to verify the efficacy of this agent
- YM Biosciences look to broaden TheraCIM' s horizons
- Forecasts to 2016
- Datamonitor drug assessment summary
- Xinlay (Atrasentan; Abbott Laboratories)
- Drug overview
- Xinlay' s target receptor plays a key role in cancer cell
proliferation
- Key historical events
- Clinical trial data
- FDA do not approve Xinlay for prostate cancer
- Not the end of the road for Xinlay with new Phase III trial now
underway
- Datamonitor comments
- Despite its rejection by the FDA, Xinlay' s future may still be
promising
- Abbott' s favorable position in the prostate cancer market will be
invaluable
- Forecasts to 2016
- Datamonitor drug assessment summary
- Zalutumumab (HuMax-EGFR; Genmab)
- Drug overview
- Key historical events
- Clinical trial data
- With Fast Track status granted, SCCHN offers promise as a lead
indication for zalutumumab
- Datamonitor comments
- A head-to-head study against Erbitux could work in zalutumumab' s
favor
- Zalutumumab will need to be competitively priced
- Zalutumumab may also have to compete with Tarceva and Iressa
- Forecasts to 2016
- Datamonitor drug assessment summary
- Zarnestra (Tipifarnib; Johnson & Johnson)
- Drug overview
- Key historical events
- Clinical trial data
- Following rejection of NDA, the FDA requires Phase III data for
Zarnestra in AML before regulatory approval can be considered
- Results from Phase III studies have yet to be announced
- Zarnestra has demonstrated a favorable profile in Phase II studies
- Single-agent Zarnestra demonstrates antitumor activity in
relapsed/refractory aggressive NHL
- Zarnestra holding promise in juvenile myelomonocytic leukemia
- Following modest activity in brain cancer, further trials have been
initiated
- Negative Phase III trial results cause termination of development in
pancreatic and colorectal cancer
- Datamonitor comments
- Schering-Plough' s Sarasar catching up with Zarnestra as the first
farnesyl transferase inhibitor to reach the market
- Johnson & Johnson limiting Zarnestra' s target population in the
short term
- Johnson & Johnson' s experience will be invaluable to Zarnestra
- Forecasts to 2016
- Datamonitor drug assessment summary
- CHAPTER 6 PIPELINE MULTI-TARGETED INHIBITORS ANALYSIS & FORECASTS
- Overview of multi-targeted inhibitors
- Pipeline summary
- Late-phase pipeline of multi-targeted inhibitors
- Phase II pipeline of multi-targeted inhibitors
- Phase I pipeline of multi-targeted inhibitors
- Comparative forecasts
- Definition of current comparator therapy
- Gleevec (Imatinib; Novartis)
- Tasigna (Nilotinib, AMN-107; Novartis)
- Drug overview
- Key historical events
- Clinical trial data
- Tasigna awaiting approval in the US, the EU and Japan for
Gleevec-resistant CML
- Promising Phase II data reported
- Tasigna appears effective in CML patients who have failed or are
intolerant to both Gleevec and Sprycel
- Only one Bcr-Abl mutation is insensitive to Tasigna
- Tasigna shows promise for Gleevec-resistant metastatic GIST patients
- Datamonitor comments
- Tasigna ready to challenge Bristol-Myers Squibb' s already approved
Sprycel
- Novartis looking to expand its leading role in the CML therapy market
- Forecasts to 2016
- Datamonitor drug assessment summary
- Axitinib (AG-13736; Pfizer)
- Drug overview
- Key historical events
- Clinical trial data
- Phase III trial warranted in pancreatic cancer following a 26%
reduction in the risk of death when axitinib is added to Gemzar - Phase
II results
- Axitinib demonstrates impressive activity in thyroid cancer. Phase
III trial yet to start
- Axitinib also making encouraging progress in other popular tumor
types
- Datamonitor comments
- A similar response rate to Tarceva in pancreatic cancer means
approval will be likely
- Axitinib will enjoy the global presence and unparalleled marketing
strength Pfizer can offer
- Forecasts to 2016
- Datamonitor drug assessment summary
- Ceflatonin (Myelostat; ChemGenex Pharmaceuticals)
- Drug overview
- Key historical events
- Clinical trial data
- Ceflatonin aims to restore Gleevec sensitivity in CML patients
- ChemGenex looking to expand Ceflatonin into the AML/APL market
- Datamonitor comments
- Despite convincing clinical benefit, Ceflatonin will face strong
competition from Bristol-Myers Squibb' s Sprycel and Novartis' s Tasigna
- Forecasts to 2016
- Datamonitor drug assessment summary
- Enzastaurin (LY317615; Eli Lilly)
- Drug overview
- Key historical events
- Clinical trial data
- Enzastaurin looking to make its mark in the B-cell lymphoma market
- Enzastaurin holding promise as a maintenance therapy in mantle cell
lymphoma
- Despite discontinuation of a Phase III trial in Glioma, Eli Lilly
has initiated 20 additional clinical trials
- Datamonitor comments
- Eli Lilly adopt a risky strategy for enzastaurin in DLBCL
- Termination of Phase III trial for enzastaurin in glioma may hamper
its potential in other indications
- Forecasts to 2016
- Datamonitor drug assessment summary
- Lestaurtinib (CEP-701; Cephalon)
- Drug overview
- Key historical events
- Clinical trial data
- Lestaurtinib emerging as a promising agent for AML patients
harboring Flt-3 activating mutations
- Datamonitor comments
- Lestaurtinib may be the first in its class to reach the market
- Cephalon' s recent acquisition of Trisenox will provide valuable
experience of the leukemia market
- Forecasts to 2016
- Datamonitor drug assessment summary
- Zactima (Vandetanib, ZD6474; AstraZeneca)
- Drug overview
- Key historical events
- Clinical trial data
- Zactima granted Orphan Drug designation and Fast Track status for
Thyroid cancer
- Multiple Phase III trials for Zactima underway in NSCLC
- Zactima fails to demonstrate efficacy as a maintenance therapy for
SCLC
- Datamonitor comments
- Zactima set to enjoy a monopoly of thyroid cancer niche market
- Zactima being pushed through the clinical development process for
NSCLC
- Zactima offers product differentiation with unique multi-targeted
characteristics
- AstraZeneca' s strength in the oncology market will be key in
Zactima' s success
- Forecasts to 2016
- Datamonitor drug assessment summary
- CHAPTER 7 PIPELINE CELL CYCLE AND APOPTOSIS TARGETED AGENTS ANALYSIS &
FORECASTS
- Overview of cell cycle and apoptosis targeted agents
- Pipeline summary
- Late-phase pipeline of cell cycle and apoptosis targeted agents
- Phase II pipeline of cell cycle and apoptosis targeted agents
- Phase I pipeline of cell cycle and apoptosis targeted agents
- Comparative forecasts
- Definition of current comparator therapy
- Velcade (Bortezomib; Millennium Pharmaceuticals)
- Alvocidib (Flavopiridol; Sanofi-Aventis)
- Drug overview
- Key historical events
- Clinical trial data
- Continuous infusion dosing schedules fail to demonstrate clinical
activity
- Modified dosing regimen drives further development in CLL
- Datamonitor comments
- Given alvocidib' s checkered history, Sanofi-Aventis may face an
uphill struggle communicating the drug' s potential
- Alvocidib may show more promise as part of a combination regimen
- Presence in oncology field will aid commercialization of alvocidib
- Genasense (Oblimersen; Genta)
- Drug overview
- Key historical events
- Datamonitor comments
- Approval of Genasense is looking increasingly unlikely
- Termination of agreement with Sanofi-Aventis is a major setback for
Genta
- Forecasts to 2016
- Datamonitor drug assessment summary
- Phenoxodiol (Novogen)
- Drug overview
- Key historical events
- Clinical trial data
- The OVATURE trials
- The combination of phenoxodiol and cisplatin is particularly
effective in ovarian cancer
- Datamonitor comments
- Toxicity will be the key factor for phenoxodiol' s success
- Sanofi-Aventis as a marketing partner?
- Forecasts to 2016
- Datamonitor drug assessment summary
- CHAPTER 8 PIPELINE IMMUNOMODULATORY AND IMMUNOCONJUGATED THERAPEUTICS
ANALYSIS & FORECASTS
- Overview of immunomodulatory and immunoconjugated therapeutics
- Pipeline summary
- Late-phase pipeline of immunomodulatory and immunoconjugated
therapeutics
- Phase II pipeline of immunomodulatory and immunoconjugated
therapeutics
- Phase I pipeline of immunomodulatory and immunoconjugated
therapeutics
- Comparative forecasts
- Definition of current comparator therapy
- Rituxan (Rituximab; Biogen Idec/Genentech/Roche)
- Galiximab (Anti-CD80 MAb; Biogen Idec)
- Drug overview
- Key historical events
- Clinical trial data
- Randomized Phase III trial will compare survival of galiximab plus
Rituxan with Rituxan alone in relapsed/refractory follicular NHL patients
- Phase II results show galiximab and Rituxan can be safely combined
and can produce promising response rates in follicular NHL patients
- Datamonitor comments
- Biogen Idec in a strong position to successfully market galiximab
alone
- Biogen-Idec will need to effectively demonstrate the value of a
combination of galiximab and Rituxan to payers
- Forecasts to 2016
- Datamonitor drug assessment summary
- Lumiliximab (Anti-CD23 MAb; Biogen Idec)
- Drug overview
- Key historical events
- Clinical trial data
- The addition of lumiliximab to the FCR regimen may produce a higher
response rate without additional toxicity
- Datamonitor comments
- Lumiliximab on course to become an established addition to the
standard treatment for CLL
- Biogen Idec should look to investigate Lumiliximab as a maintenance
therapy
- Cluster of Differentiation (CD) drugs have become Biogen Idec' s
specialty
- Forecasts to 2016
- Datamonitor drug assessment summary
- Ofatumumab (HuMax-CD20; Genmab/GlaxoSmithKline)
- Drug overview
- Genmab hoping ofatumumab will demonstrate a preferred efficacy
profile over Rituxan in the clinic
- Key historical events
- Clinical trial data
- Ofatumumab receives Fast Track status for CLL and enters a Phase III
trial
- Genmab initiates a pivotal Phase III trial in follicular NHL
- Datamonitor comments
- Ofatumumab may offer hope for Rituxan-insensitive patients
- Approval of other MAbs being developed by Biogen Idec for NHL and
CLL may restrict ofatumumab' s potential even further
- GlaxoSmithKline will offer invaluable experience to Genmab and aid
commercialization of ofatumumab
- Forecasts to 2016
- Datamonitor drug assessment summary
- Proxinium/Vicinium (VB4-845; Viventia Biotech)
- Drug overview
- An ' armed' antibody for the potential treatment of head and neck,
and bladder cancer
- Key historical events
- Clinical trial data
- Proxinium shows a good safety profile and preliminary evidence of
clinical efficacy in Phase I trials in head and neck cancer
- Vicinium also making headway in bladder cancer
- Datamonitor comments
- The requirement for EpCAM expression may limit Proxinium' s uptake
- Proxinium will have to compete with Erbitux
- Viventia should look to investigate Proxinium in combination with
radiotherapy
- BCG failure creates a commercial opportunity for Vicinium
- Vicinium may face competitive pressure from novel intravesical
chemotherapies in the near future
- Forecasts to 2016
- Datamonitor drug assessment summary
- Rencarex (WX-G250; Wilex)
- Drug overview
- MN/CA IX Antigen - A highly specific tumor target
- Mode of Action of Rencarex - ADCC
- Key historical events
- Clinical trial data
- Completed Phase I & II trials for metastatic RCC
- In patients responding to treatment, Rencarex monotherapy improves
survival
- The combination with IFN is well-tolerated and of clinical benefit
in metastatic RCC
- Datamonitor comments
- The high recurrence rate for RCC creates a commercial opportunity
- Rencarex may face a number of hurdles
- Forecasts to 2016
- Datamonitor drug assessment summary
- Zanolimumab (HuMax-CD4; Genmab)
- Drug overview
- Key historical events
- Clinical trial data
- Zanolimumab' s Orphan Drug and Fast Track status reflects the high
unmet needs in CTCL
- Zanolimumab may also hold promise for PTCL patients
- Datamonitor comments
- The T-cell lymphoma market offers zanolimumab a limited commercial
potential
- Depletion of CD4+ T-cells by zanolimumab may render the patient
susceptible to opportunistic infections
- Forecasts to 2016
- Datamonitor drug assessment summary
- CHAPTER 9 PIPELINE EPIGENETIC MODULATORS ANALYSIS & FORECASTS
- Overview of epigenetic modulators
- Pipeline summary
- Late-phase pipeline of epigenetic modulators
- Phase II pipeline of epigenetic modulators
- Phase I pipeline of epigenetic modulators
- APPENDIX
- List of tables
- List of figures
- Methodology
- Datamonitor forecast methodology
- Epidemiology forecasts
- Product forecasts
- Datamonitor drug assessment summary
- Abbreviations
- Contributing experts
- Bibliography
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Late-phase pipeline molecular targeted cancer therapies, 2007
- Table 2: Phase II pipeline molecular targeted cancer therapies, 2007
- Table 3: Phase I pipeline molecular targeted cancer therapies, 2007
- Table 4: Pipeline molecular targeted therapies by development phase
and class of drug, 2007
- Table 5: Pipeline molecular targeted therapies by indication, 2007
- Table 6: Potential anticancer molecular targets being exploited by
only one candidate in the clinical development pipeline, 2007
- Table 7: Potential anticancer molecular targets being exploited by two
candidates in the clinical development pipeline, 2007
- Table 8: Potential anticancer molecular targets being exploited by
three candidates in the clinical development pipeline, 2007
- Table 9: Pfizer' s marketed cancer portfolio, 2007
- Table 10: Pfizer' s molecular targeted cancer therapies pipeline, 2007
- Table 11: AstraZeneca' s marketed cancer portfolio, 2007
- Table 12: AstraZeneca' s molecular targeted cancer therapies pipeline,
2007
- Table 13: Novartis' s marketed cancer portfolio, 2007
- Table 14: Novartis' s molecular targeted cancer therapies pipeline, 2007
- Table 15: Late-phase pipeline molecular targeted therapy products
sales forecasts in the seven major markets ($m), 2007-2016
- Table 16: Currently approved molecular targeted cancer therapies, 2007
- Table 17: Examples of naturally occurring angiogenesis stimulators
- Table 18: Recently approved multi-targeted inhibitors, 2007
- Table 19: Late-phase pipeline angiogenesis inhibitors, 2007
- Table 20: Phase II pipeline angiogenesis inhibitors, 2007
- Table 21: Phase I pipeline angiogenesis inhibitors, 2007
- Table 22: Forecasting assumptions for late-phase angiogenesis
inhibitors in the seven major pharmaceutical markets, 2007 (1 of 2)
- Table 23: Forecasting assumptions for late-phase angiogenesis
inhibitors in the seven major pharmaceutical markets, 2007 (2 of 2)
- Table 24: Avastin: Key facts
- Table 25: Aflibercept: Key historical events
- Table 26: Ongoing clinical trials involving aflibercept, 2007
- Table 27: Interim Phase II results for aflibercept in NSCLC
- Table 28: Forecasting assumptions for aflibercept in the seven major
pharmaceutical markets, 2007
- Table 29: Aflibercept 7MM sales forecast in second-line ovarian
cancer, second-line NSCLC and second-line HRPC ($m), 2007-2016
- Table 30: Pazopanib: Key historical events
- Table 31: Ongoing clinical trials involving pazopanib, 2007
- Table 32: Phase II interim analysis for pazopanib monotherapy in
second-line RCC at 12 weeks
- Table 33: Phase II interim analysis for pazopanib monotherapy in
relapsed soft tissue sarcoma at 12 weeks
- Table 34: Phase II interim analysis for pazopanib monotherapy in
high-risk relapsed ovarian cancer at 12 weeks
- Table 35: Forecasting assumptions for pazopanib in the seven major
pharmaceutical markets, 2007
- Table 36: Pazopanib 7MM sales forecast in first/second-line RCC and
second-line Her2+ breast cancer ($m), 2007-2016
- Table 37: Recentin: Key historical events
- Table 38: Ongoing clinical trials involving Recentin, 2007
- Table 39: Phase I results of Recentin plus standard chemotherapy in
NSCLC
- Table 40: Forecasting assumptions for Recentin in the seven major
pharmaceutical markets, 2007
- Table 41: Recentin 7MM sales forecast in first-line NSCLC, first-line
CRC and recurrent/ progressive glioma ($m), 2007-2016
- Table 42: Late-phase pipeline single-target signal transduction
inhibitors, 2007
- Table 43: Phase II pipeline single-target signal transduction
inhibitors, 2007
- Table 44: Phase I pipeline single-target signal transduction
inhibitors, 2007
- Table 45: Forecasting assumptions for late-phase single-target signal
transduction inhibitors in the seven major pharmaceutical markets, 2007 (1
of 3)
- Table 46: Forecasting assumptions for late-phase single-target signal
transduction inhibitors in the seven major pharmaceutical markets, 2007 (2
of 3)
- Table 47: Forecasting assumptions for late-phase single-target signal
transduction inhibitors in the seven major pharmaceutical markets, 2007 (3
of 3)
- Table 48: Gleevec: Key facts
- Table 49: Certican: Key historical events
- Table 50: Ongoing clinical trials involving Certican, 2007
- Table 51: Phase II study results for Certican plus octreotide in NET
- Table 52: Interim Phase II results of Certican monotherapy in
metastatic RCC
- Table 53: Interim Phase II results of Certican monotherapy in lymphoma
- Table 54: Forecasting assumptions for Certican in the seven major
pharmaceutical markets, 2007
- Table 55: Certican 7MM sales forecast in second-line NET, second-line
RCC, salvage therapy CRC and second-line GIST ($m), 2007-2016
- Table 56: Sarasar: Key historical events
- Table 57: Ongoing clinical trials involving Sarasar, 2007
- Table 58: Phase I/II study results of Sarasar monotherapy in advanced
MDS and CMML (1 of 2)
- Table 59: Phase I/II study results of Sarasar monotherapy in advanced
MDS and CMML (2 of 2)
- Table 60: Phase II results of Sarasar in Head and Neck cancer
- Table 61: Forecasting assumptions for Sarasar in the seven major
pharmaceutical markets, 2007
- Table 62: Sarasar 7MM sales forecast in second-line MDS ($m), 2007-2016
- Table 63: TheraCIM: Key historical events
- Table 64: Ongoing clinical trials involving TheraCIM, 2007
- Table 65: Forecasting assumptions for TheraCIM in the seven major
pharmaceutical markets, 2007
- Table 66: TheraCIM 7MM sales forecast in first-line glioma ($m),
2007-2016
- Table 67: Xinlay: Key historical events
- Table 68: Ongoing clinical trials involving Xinlay, 2007
- Table 69: Meta-analysis of pooled data from two randomized Phase III
trials (M96-594 and M00-211) of Xinlay versus placebo in metastatic HRPC
- Table 70: Forecasting assumptions for Xinlay in the seven major
pharmaceutical markets, 2007
- Table 71: Xinlay 7MM sales forecast in first-line metastatic HRPC
($m), 2007-2016
- Table 72: Zalutumumab: Key historical events
- Table 73: Ongoing clinical trials involving zalutumumab, 2007
- Table 74: Phase I/II study results of zalutumumab in recurrent SCCHN
- Table 75: Forecasting assumptions for zalutumumab in the seven major
pharmaceutical markets, 2007
- Table 76: Zalutumumab 7MM sales forecast in first/second-line SCCHN
($m), 2007-2016
- Table 77: Zarnestra: Key historical events
- Table 78: Ongoing clinical trials involving Zarnestra, 2007
- Table 79: Phase I/II study of Zarnestra in combination with
chemotherapy in newly diagnosed AML or high-risk MDS patients
- Table 80: Phase II results for Zarnestra in elderly, previously
untreated poor-risk AML patients who were not suitable for chemotherapy
- Table 81: Phase II results of Zarnestra monotherapy in
relapsed/refractory aggressive NHL, 2006
- Table 82: Phase II study results of Zarnestra in juvenile
myelomonocytic leukemia (JMML), 2005
- Table 83: Phase I/II trial involving Nexavar, Tarceva, Torisel and
Zarnestra, 2006
- Table 84: Phase III trial results of Zarnestra in pancreatic cancer
- Table 85: Phase III trial results of Zarnestra in CRC
- Table 86: Forecasting assumptions for Zarnestra in the seven major
pharmaceutical markets, 2007
- Table 87: Zarnestra 7MM sales forecasts in first-line elderly AML
($m), 2007-2016
- Table 88: Late-phase pipeline multi-targeted inhibitors, 2007
- Table 89: Phase II pipeline multi-targeted inhibitors, 2007
- Table 90: Phase I pipeline multi-targeted inhibitors, 2007
- Table 91: Forecasting assumptions for late-phase multi-targeted
inhibitors in the seven major pharmaceutical markets, 2007 (1 of 2)
- Table 92: Forecasting assumptions for late-phase multi-targeted
inhibitors in the seven major pharmaceutical markets, 2007 (2 of 2)
- Table 93: Gleevec: Key facts
- Table 94: Tasigna: Key historical events
- Table 95: Ongoing clinical trials involving Tasigna, 2007
- Table 96: Trial design and clinical outcomes for a small patient
subgroup from the ENACT trial
- Table 97: Phase II results for Tasigna in Gleevec-resistant or
intolerant patients with CML in chronic phase
- Table 98: Phase II results for Tasigna in Gleevec-resistant or
intolerant patients with CML in accelerated phase
- Table 99: Phase II results for Tasigna in Gleevec-resistant or
intolerant patients with CML in blast crisis phase or relapsed/refractory
Ph+ ALL
- Table 100: Phase II results for Tasigna in hypereosinophilic syndrome
(HES)
- Table 101: Phase II results for Tasigna in systemic mastocytosis
- Table 102: Phase II results for Tasigna in Gleevec and
Sprycel-resistant or intolerant patients with CML in all stages of the
disease
- Table 103: Phase I results for Tasigna with or without Gleevec in
Gleevec-resistant GIST
- Table 104: Forecasting assumptions for Tasigna in the seven major
pharmaceutical markets, 2007
- Table 105: Tasigna sales forecast in Gleevec-refractory CML and
third-line GIST ($m), 2007-2016
- Table 106: Axitinib: Key historical events
- Table 107: Ongoing clinical trials involving axitinib, 2007
- Table 108: Phase II results for axitinib in thyroid cancer
- Table 109: Phase II results for axitinib in Nexavar-refractory mRCC
- Table 110: Phase II results for axitinib in relapsed NSCLC
- Table 111: Forecasting assumptions for axitinib in the seven major
pharmaceutical markets, 2007
- Table 112: Axitinib 7MM sales forecast in first-line pancreatic cancer
and second-line thyroid cancer ($m), 2007-2016
- Table 113: Ceflatonin: Key historical events
- Table 114: Ongoing clinical trials involving Ceflatonin, 2007
- Table 115: Interim data for Ceflatonin monotherapy in patients with
Gleevec-refractory CML harboring the T315I Bcr-Abl point mutation
- Table 116: Phase II trial outline for Ceflatonin plus Gleevec in
Gleevec-refractory patients
- Table 117: Interim data for Ceflatonin in combination with Gleevec in
patients with Gleevec-refractory CML
- Table 118: Forecasting assumptions for Ceflatonin in the seven major
pharmaceutical markets, 2007
- Table 119: Ceflatonin 7MM sales forecast in Gleevec-resistant CML
($m), 2007-2016
- Table 120: Enzastaurin: Key historical events
- Table 121: Ongoing clinical trials involving enzastaurin, 2007
- Table 122: Phase II results of enzastaurin in relapsed DLBCL
- Table 123: Phase II results of enzastaurin in relapsed MCL
- Table 124: Phase II results of enzastaurin in second/third-line NSCLC
- Table 125: Forecasting assumptions for enzastaurin in the seven major
pharmaceutical markets, 2007
- Table 126: Enzastaurin 7MM sales forecast as a maintenance therapy in
DLBCL ($m), 2007-2016
- Table 127: Lestaurtinib: Key historical events
- Table 128: Ongoing clinical trial involving lestaurtinib, 2007
- Table 129: Interim Phase II/III results of lestaurtinib and
chemotherapy in patients with relapsed AML harboring Flt-3 activating
mutations
- Table 130: Forecasting assumptions for lestaurtinib in the seven major
pharmaceutical markets, 2007
- Table 131: Lestaurtinib 7MM sales forecast in second-line AML ($m),
2007-2016
- Table 132: Zactima' s multiple anticancer targets
- Table 133: Zactima: Key historical events
- Table 134: Ongoing clinical trials involving Zactima, 2007
- Table 135: Phase II results for Zactima monotherapy in metastatic
hereditary medullary thyroid cancer
- Table 136: Phase II results for Zactima plus chemotherapy in
first-line NSCLC
- Table 137: Phase II results for Zactima plus Taxotere in second-line
NSCLC
- Table 138: Phase I results for Zactima plus Alimta in second-line NSCLC
- Table 139: Forecasting assumptions for Zactima in the seven major
pharmaceutical markets, 2007
- Table 140: Zactima 7MM sales forecast in NSCLC ($m), 2007-2016
- Table 141: Late-phase pipeline cell cycle and apoptosis targeted
agents, 2007
- Table 142: Phase II pipeline cell cycle and apoptosis targeted agents,
2007
- Table 143: Phase I pipeline cell cycle and apoptosis targeted agents,
2007
- Table 144: Forecasting assumptions for late-phase cell cycle and
apoptosis targeted agents in the seven major pharmaceutical markets, 2007
- Table 145: Velcade: Key facts
- Table 146: Alvocidib: Key historical events
- Table 147: Ongoing clinical trials involving alvocidib, 2007
- Table 148: Genasense: Key historical events
- Table 149: Forecasting assumptions for Genasense in the seven major
pharmaceutical markets, 2007
- Table 150: Genasense 7MM sales forecast in first-line elderly AML and
first-line metastatic melanoma ($m), 2007-2016
- Table 151: Phenoxodiol: Key historical events
- Table 152: Ongoing clinical trials involving phenoxodiol, 2007
- Table 153: Forecasting assumptions for phenoxodiol in the seven major
pharmaceutical markets, 2007
- Table 154: Phenoxodiol 7MM sales forecast in third-line ovarian cancer
($m), 2007-2016
- Table 155: Late-phase pipeline immunomodulatory and immunoconjugated
therapeutics, 2007
- Table 156: Phase II pipeline immunomodulatory and immunoconjugated
therapeutics, 2007
- Table 157: Phase I pipeline immunomodulatory and immunoconjugated
therapeutics, 2007
- Table 158: Forecasting assumptions for late-phase immunomodulatory and
immunoconjugated therapeutics in the seven major pharmaceutical markets,
2007 (1 of 2)
- Table 159: Forecasting assumptions for late-phase immunomodulatory and
immunoconjugated therapeutics in the seven major pharmaceutical markets,
2007 (2 of 2)
- Table 160: Approved indications for Rituxan in the US and EU, 2006
- Table 161: Rituxan: Key facts
- Table 162: Galiximab: Key historical events
- Table 163: Ongoing clinical trial involving galiximab, 2007
- Table 164: Phase II study of galiximab in combination with Rituxan in
relapsed/refractory follicular NHL
- Table 165: Retrospective comparison of galiximab plus Rituxan with
Rituxan monotherapy in relapsed/refractory follicular NHL
- Table 166: Forecasting assumptions for galiximab in the seven major
pharmaceutical markets, 2007
- Table 167: Galiximab 7MM sales forecast in follicular NHL ($m),
2007-2016
- Table 168: Lumiliximab: Key historical events
- Table 169: Ongoing clinical trial involving lumiliximab, 2007
- Table 170: Comparison of results from a Phase I/II study of
lumiliximab in combination with FCR in relapsed/refractory CLL
- Table 171: Biogen Idec' s Cluster of Differentiation (CD) targeted
drugs, 2007
- Table 172: Forecasting assumptions for lumiliximab in the seven major
pharmaceutical markets, 2007
- Table 173: Lumiliximab 7MM sales forecast in relapsed/refractory CLL
($m), 2007-2016
- Table 174: Ofatumumab: Key historical events
- Table 175: Ongoing clinical trial involving ofatumumab, 2007
- Table 176: Phase I/II results of ofatumumab in relapsed/refractory CLL
- Table 177: Interim Phase I/II results of ofatumumab in
relapsed/refractory follicular NHL
- Table 178: Phase I/II adverse events data from ofatumumab in
relapsed/refractory follicular NHL
- Table 179: GlaxoSmithKline' s marketed oncology portfolio, 2007
- Table 180: Forecasting assumptions for ofatumumab in the seven major
pharmaceutical markets, 2007
- Table 181: Ofatumumab 7MM sales forecast in relapsed/refractory CLL
and second-line follicular NHL ($m), 2007-2016
- Table 182: Proxinium: Key historical events
- Table 183: Ongoing clinical trials involving Proxinium, 2007
- Table 184: Forecasting assumptions for Proxinium in the seven major
pharmaceutical markets, 2007
- Table 185: Proxinium 7MM sales forecast in second-line SCCHN ($m),
2007-2016
- Table 186: Rencarex: Key historical events
- Table 187: Ongoing clinical trials involving Rencarex, 2007
- Table 188: Phase I/II study of Rencarex plus IFN in metastatic RCC
- Table 189: Ongoing Phase III trials in the adjuvant RCC setting
- Table 190: Forecasting assumptions for Rencarex in the seven major
pharmaceutical markets, 2007
- Table 191: Rencarex 7MM sales forecast in adjuvant RCC ($m), 2007-2016
- Table 192: Zanolimumab: Key historical events
- Table 193: Ongoing clinical trial involving zanolimumab, 2007
- Table 194: Phase II results of zanolimumab in mycosis fungoides CTCL
- Table 195: Interim Phase II results of zanolimumab in PTCL patients
- Table 196: Forecasting assumptions for zanolimumab in the seven major
pharmaceutical markets, 2007
- Table 197: Zanolimumab 7MM sales forecast in relapsed CTCL ($m),
2007-2016
- Table 198: Zolinza: Key facts
- Table 199: Phase II pipeline epigenetic modulators, 2007
- Table 200: Phase I pipeline epigenetic modulators, 2007
- Table 201: Datamonitor drug assessment parameters
- Table 202: Abbreviations used in Pipeline Insight: Molecular Targeted
Cancer Therapies
- List of Figures
- Figure 1: Pipeline molecular targeted therapies by development phase
and class of drug, 2007
- Figure 2: Pipeline molecular targeted therapies by class of drug, 2007
- Figure 3: Pipeline molecular targeted therapies by development phase,
2007
- Figure 4: Angiogenesis inhibitors by developmental phase, 2007
- Figure 5: Single-target signal transduction inhibitors by
developmental phase, 2007
- Figure 6: Multi-targeted inhibitors by developmental phase, 2007
- Figure 7: Cell cycle and apoptosis targeted agents by developmental
phase, 2007
- Figure 8: Immunomodulatory and immunoconjugated therapeutics by
developmental phase, 2007
- Figure 9: Epigenetic modulators by developmental phase, 2007
- Figure 10: Pipeline molecular targeted therapies by indication, 2007
- Figure 11: Pipeline molecular targeted therapies by hematological
malignancy, 2007
- Figure 12: Potential anticancer molecular targets being exploited by
four or more candidates in the clinical development pipeline, 2007
- Figure 13: Molecular targeted therapies product pipeline by type of
company, 2007
- Figure 14: Segmentation of companies according to number of products
in the MTT pipeline, 2007
- Figure 15: Companies with MTT candidates in late-phase development,
2007
- Figure 16: Companies with four or more candidates in the molecular
targeted therapies pipeline, 2007
- Figure 17: Pipeline angiogenesis inhibitors sales forecasts across the
seven major markets ($m), 2007-2016
- Figure 18: Pipeline single-target signal transduction inhibitors sales
forecasts across the seven major markets ($m), 2007-2016
- Figure 19: Pipeline multi-targeted inhibitors sales forecasts across
the seven major markets ($m), 2007-2016
- Figure 20: Pipeline cell cycle and apoptosis targeted agents sales
forecasts across the seven major markets ($m), 2007-2016
- Figure 21: Pipeline immunomodulatory and immunoconjugated therapeutics
sales forecasts across the seven major markets ($m), 2007-2016
- Figure 22: Clinical and commercial attractiveness of pipeline
angiogenesis inhibitors, 2007
- Figure 23: Clinical and commercial attractiveness of pipeline
single-target signal transduction inhibitors, 2007
- Figure 24: Clinical and commercial attractiveness of pipeline
multi-targeted inhibitors, 2007
- Figure 25: Clinical and commercial attractiveness of pipeline cell
cycle and apoptosis targeted agents, 2007
- Figure 26: Clinical and commercial attractiveness of pipeline
immunomodulatory and immunoconjugated therapeutics, 2007
- Figure 27: The process of tumor angiogenesis
- Figure 28: Clinical and commercial attractiveness of pipeline
angiogenesis inhibitors, 2007
- Figure 29: Pipeline angiogenesis inhibitors sales forecasts in the
seven major markets ($m), 2007-2016
- Figure 30: Interim Phase II results of aflibercept in ovarian cancer
- Figure 31: Aflibercept 7MM sales forecast in second-line ovarian
cancer, second-line NSCLC and second-line HRPC ($m), 2007-2016
- Figure 32: Clinical and commercial attractiveness of aflibercept, 2007
- Figure 33: Pazopanib' s mode of action
- Figure 34: Phase III study design for pazopanib monotherapy in
second-line RCC
- Figure 35: Phase II study design for pazopanib monotherapy in
second-line RCC
- Figure 36: Phase II study design for pazopanib monotherapy in relapsed
soft tissue sarcoma
- Figure 37: Phase II study design for pazopanib monotherapy in
high-risk relapsed ovarian cancer
- Figure 38: Pazopanib 7MM sales forecast in first/second-line RCC and
second-line Her2+ breast cancer ($m), 2007-2016
- Figure 39: Clinical and commercial attractiveness of pazopanib, 2007
- Figure 40: Recentin (cediranib; AZD2171) mode of action
- Figure 41: Phase I interim results for Recentin in second-line CRC
- Figure 42: HORIZON II and HORIZON III clinical trials designs
involving Recentin in first-line CRC
- Figure 43: Recentin 7MM sales forecast in first-line NSCLC, first-line
CRC and recurrent/ progressive glioma ($m), 2007-2016
- Figure 44: Clinical and commercial attractiveness of Recentin, 2007
- Figure 45: Clinical and commercial attractiveness of pipeline
single-target signal transduction inhibitors, 2007
- Figure 46: Pipeline single-target signal transduction inhibitors sales
forecasts in the seven major markets ($m), 2007-2016
- Figure 47: Phase II results of Certican monotherapy in breast cancer
- Figure 48: Phase II results of Certican monotherapy in NSCLC
- Figure 49: Certican 7MM sales forecast in second-line NET, second-line
RCC, salvage therapy CRC and second-line GIST ($m), 2007-2016
- Figure 50: Clinical and commercial attractiveness of Certican, 2007
- Figure 51: Sarasar 7MM sales forecast in second-line MDS ($m),
2007-2016
- Figure 52: Clinical and commercial attractiveness of Sarasar, 2007
- Figure 53: Phase II trial results for TheraCIM in pediatric glioma
- Figure 54: TheraCIM 7MM sales forecast in first-line glioma ($m),
2007-2016
- Figure 55: Clinical and commercial attractiveness of TheraCIM, 2007
- Figure 56: Clinical trial design for the recently initiated Phase III
trial involving Xinlay in HRPC
- Figure 57: Xinlay 7MM sales forecast in first-line metastatic HRPC
($m), 2007-2016
- Figure 58: Clinical and commercial attractiveness of Xinlay, 2007
- Figure 59: Types of monoclonal antibodies
- Figure 60: Zalutumumab 7MM sales forecast in first/second-line SCCHN
($m), 2007-2016
- Figure 61: Clinical and commercial attractiveness of zalutumumab, 2007
- Figure 62: Phase I/II trial design of Zarnestra in combination with
chemotherapy in newly diagnosed AML or high-risk MDS patients
- Figure 63: Zarnestra 7MM sales forecasts in first-line elderly AML
($m), 2007-2016
- Figure 64: Clinical and commercial attractiveness of Zarnestra, 2007
- Figure 65: Clinical and commercial attractiveness of pipeline
multi-targeted inhibitors, 2007
- Figure 66: Pipeline multi-targeted inhibitors sales forecasts ($m),
2007-2016
- Figure 67: Phase I study outline for Tasigna with or without Gleevec
in Gleevec-resistant GIST
- Figure 68: Tasigna sales forecast in Gleevec-refractory CML and
third-line GIST ($m), 2007-2016
- Figure 69: Clinical and commercial attractiveness of Tasigna, 2007
- Figure 70: Phase II results for axitinib plus Gemzar in first-line
pancreatic cancer
- Figure 71: Randomized Phase II study results for axitinib plus
Taxotere in first-line metastatic breast cancer
- Figure 72: Axitinib 7MM sales forecast in first-line pancreatic cancer
and second-line thyroid cancer ($m), 2007-2016
- Figure 73: Clinical and commercial attractiveness of axitinib, 2007
- Figure 74: Phase II/III trial for Ceflatonin in Gleevec-refractory CML
- Figure 75: Ceflatonin 7MM sales forecast in Gleevec-resistant CML
($m), 2007-2016
- Figure 76: Clinical and commercial attractiveness of Ceflatonin, 2007
- Figure 77: Enzastaurin 7MM sales forecast as a maintenance therapy in
DLBCL ($m), 2007-2016
- Figure 78: Clinical and commercial attractiveness of enzastaurin, 2007
- Figure 79: Lestaurtinib 7MM sales forecast in second-line AML ($m),
2007-2016
- Figure 80: Clinical and commercial attractiveness of lestaurtinib, 2007
- Figure 81: Phase II results for maintenance Zactima in SCLC
- Figure 82: Zactima 7MM sales forecast in NSCLC ($m), 2007-2016
- Figure 83: Clinical and commercial attractiveness of Zactima, 2007
- Figure 84: Clinical and commercial attractiveness of pipeline cell
cycle and apoptosis targeted agents, 2007
- Figure 85: Pipeline cell cycle and apoptosis targeted agents sales
forecasts ($m), 2007-2016
- Figure 86: Phase I results for alvocidib monotherapy in CLL
- Figure 87: Phase II results for alvocidib plus chemotherapy in acute
leukemias
- Figure 88: Genasense 7MM sales forecast in first-line elderly AML and
first-line metastatic melanoma ($m), 2007-2016
- Figure 89: Clinical and commercial attractiveness of Genasense, 2007
- Figure 90: Phase II results for phenoxodiol plus chemotherapy in
resistant/refractory ovarian cancer
- Figure 91: Phenoxodiol 7MM sales forecast in third-line ovarian cancer
($m), 2007-2016
- Figure 92: Clinical and commercial attractiveness of phenoxodiol, 2007
- Figure 93: Clinical and commercial attractiveness of pipeline
immunomodulatory and immunoconjugated therapeutics, 2007
- Figure 94: Pipeline immunomodulatory and immunoconjugated therapeutics
sales forecasts ($m), 2007-2016
- Figure 95: Galiximab 7MM sales forecast in follicular NHL ($m),
2007-2016
- Figure 96: Clinical and commercial attractiveness of galiximab, 2007
- Figure 97: Phase I/II study design for lumiliximab in combination with
FCR in relapsed/refractory CLL
- Figure 98: Lumiliximab 7MM sales forecast in relapsed/refractory CLL
($m), 2007-2016
- Figure 99: Clinical and commercial attractiveness of lumiliximab, 2007
- Figure 100: Phase III study design for ofatumumab in patients with CLL
refractory to both fludarabine and Campath
- Figure 101: Phase III study design for ofatumumab in
Rituxan-refractory follicular NHL
- Figure 102: Ofatumumab 7MM sales forecast in relapsed/refractory CLL
and second-line follicular NHL ($m), 2007-2016
- Figure 103: Clinical and commercial attractiveness of ofatumumab, 2007
- Figure 104: Phase I results for Proxinium in advanced SCCHN
- Figure 105: Phase I/II results for Vicinium in superficial TCC of the
bladder
- Figure 106: Proxinium 7MM sales forecast in second-line SCCHN ($m),
2007-2016
- Figure 107: Clinical and commercial attractiveness of Proxinium, 2007
- Figure 108: Rencarex induced ADCC
- Figure 109: Phase II study design for Rencarex monotherapy in advanced
RCC
- Figure 110: Rencarex Phase II results: median survival
- Figure 111: Phase I/II study design for Rencarex plus IFN in
metastatic RCC
- Figure 112: Rencarex 7MM sales forecast in adjuvant RCC ($m), 2007-2016
- Figure 113: Clinical and commercial attractiveness of Rencarex, 2007
- Figure 114: Phase III study design for zanolimumab in CTCL
- Figure 115: Preliminary results for the first stage of the Phase III
study for zanolimumab in CTCL
- Figure 116: Zanolimumab 7MM sales forecast in relapsed CTCL ($m),
2007-2016
- Figure 117: Clinical and commercial attractiveness of zanolimumab, 2007
- Figure 118: Datamonitor drug assessment summary of pipeline molecular
targeted therapies in development for hematological malignancies, 2007
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