Optimizing Targeted Treatment in Cancer: Negotiating the Challenges to Success

Questions: Discounts, Updates etc.

Price: $1,900.00

Publication Date: 2005-09-02

Order Online Now

Name:
Email:
Company Name:
Telephone:
Licence Type:
Payment Method:

People that purchased this report also purchased:

Contact LeadDiscovery

If you have questions about this report
To find out if you qualify for a discount
Want a more up to date version
Can't find a report that meets your needs

Search all reports

The global cancer market is poised for ongoing expansion with sales set to exceed $60bn by 2010. The emergence of novel molecular-targeted treatments will drive a significant proportion of R&D activity and future sales growth in this sector. While this will provide developers with ample opportunity for commercial reward, it will be fraught by a number of unique challenges.

Scope

Overview of the clinical and developmental challenges facing players in the oncology sector

Expert insight into strategies for improving patient selection and optimizing go and no-go decisions in progressing late stage clinical development

Lifecycle management case studies of key targeted therapy agents

Strategies to overcome pharmacoeconomic challenges hindering the uptake of targeted treatment

Report Highlights
Targeted treatment will not entirely replace traditional cytotoxic treatment and the latter will continue to form the cornerstone of cancer therapy. However, the co-administration of targeted treatment will allow the optimization of cytotoxic doses and so drive the market for both classes over the coming years

Lifecycle management in the era of targeted treatment is becoming increasingly more challenging. The key to future success will be intensified by efforts to identify responsive patient populations at an earlier stage of the drug development process

Given the mechanistic differences between small molecules and antibodies, a logical approach is to combine these two drug classes. While this is an area of active clinical research, key to the success of this economically challenging approach is to identify the best combination of drugs and the patients that will benefit most from treatment

Reasons to Purchase

Understand the clinical and strategic challenges to the commercialization of targeted treatments

Assess opportunities and risks for the continued development of innovative developmental treatments

Adopt knowledge from this Analysis to drive strategic planning decisions in oncology drug development

ABOUT DATAMONITOR HEALTHCARE - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 6
CHAPTER 2 INTRODUCTION - page 9
- A dynamic and challenging oncology market offers significant commercial opportunity - page 9
  - Growing patient population and significant unmet needs propel innovation in the cancer market - page 9
    - Cancer epidemiology - an expanding patient base - page 9
    - Cancer incidence and the aging global population - page 9
  - Sales growth in the oncology sector will outstrip that in the CV and CNS therapy areas - page 12
  - Oncology R&D has the most projects in clinical development - page 12
- The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy - page 13
  - MTTs will become an increasingly prominent therapy class - page 14
  - Clinical, regulatory and economic challenges on the path to commercialization - page 15
- Datamonitor's 'Oncology Foresight Seminar' provides vehicle for analysts and key opinion leaders to share their perspectives on challenges to commercialization of MTTs - page 16
CHAPTER 3 MEETING EXISTING UNMET NEEDS - page 18
- Successful management of advanced disease is relatively limited - page 18
  - Cytotoxic chemotherapy will continue to form the cornerstone of treatment approaches - page 19
- Improvements in symptom control, quality of life and, above all, cure rates should be the goals of MTT - page 19
CHAPTER 4 OPTIMIZING TREATMENT APPROACHES EMPLOYING MTTS - page 20
- Cancer pharmacotherapy is on the cusp of a paradigm shift - page 20
  - Novartis's Gleevec (imatinib) provides a model for future developmental strategies - page 20
  - A plethora of molecular targets offered by a greater understanding of signal transduction - page 21
  - The signal transduction paradox: is less specificity better? - page 22
  - Angiogenesis inhibitors offer greatest clinical benefit when administered in combination with chemotherapy - page 23
- Which targeted therapy class offers the greatest commercial potential? - page 24
  - Monoclonal antibodies: an unprecedented success story - page 24
  - Small molecule drugs: tumor shrinkage not consistently translated into improved survival - page 25
  - Decision to use monotherapy or combinatorial approach is dependent on drug class - page 27
  - Small molecule EGFR-TKIs have shown limited clinical benefit when administered as monotherapy - page 27
    - OSI/Genentech/Roche's Tarveca provides the only clear demonstration of clinical benefit with EGFR-TKI monotherapy - page 27
    - Millennium's Velacde provides more of a 'broad-spectrum' approach - page 28
    - Development of Johnson & Johnson's Zarnestra will benefit from improved patient selection in clinical trials - page 28
    - High-profile failures in combining small molecules with chemotherapy the result of poor patient selection? - page 29
  - Clinical activity of MoAbs appears greatest when combined with chemotherapy - page 31
    - Herceptin is set to revolutionize the treatment of HER-2 overexpressing breast cancer - page 31
    - Rituxan has demonstrated activity both as monotherapy and in combination approaches with chemotherapy - page 32
    - Erbitux proves the first example of success in combining a MTT with radiotherapy - page 33
- Dilemmas persist regarding the optimiziation of combination approaches employing MTTs - page 34
- The emerging 'richness' of targets in oncology - page 35
  - Combining two unapproved MTTs will raise complex legal issues - page 36
CHAPTER 5 INCREASED PATIENT SELECTION AND MARKET SEGMENTATION IN THE ERA OF MTT - page 38
- Issues regarding patient selection are now far more complex - page 38
  - Efficient and accurate assessment of biologically relevant target is often elusive - page 38
  - Patient selection for Herceptin treatment is the archetype - page 38
  - Fundamental to pursuing targeted patient selection are pharmacoeconomic considerations - page 40
- Improved patient selection: what tumor-specific features can be evaluated? - page 41
  - Gene amplification, gene expression and somatic mutation can help predict clinical benefit derived from MTT - page 41
    - Molecular characterization of EGFR correlates to treatment response with EGFR TKIs - page 42
    - Mutated EGFR requires lower ligand concentrations for activation - page 46
  - Patient selection for anti-angiogenic therapy - page 47
CHAPTER 6 OPTIMIZATION OF GO/NO-GO DECISIONS NECESSARY TO MITIGATE HIGH ATTRITION RATES - page 49
- Early development of diagnostic for biologically relevant target is critical - page 49
- 'Proof of concept' paradigm shift - page 50
- The randomized discontinuation trial: a novel, innovative Phase II design - page 51
- Conventially recognized definitions of response need to be re-evaluated in the age of MTT - page 56
CHAPTER 7 MTTS TARGETING MULTIPLE ONCOGENIC SIGNALS IS AN AREA OF INTENSE R&D ACTIVITY - page 57
- Pfizer and Bayer/Onxy sprint to the finish line in the race to commercialize a multi-targeted TKI - page 57
  - Renal cell carcinoma particulary susceptible to anti-angiogenic approaches - page 58
- Inhibition of multiple 'mission critical' pathways is the key to success - page 59
  - 17-AAG's anti-tumor activity results from its ability to inhibit the 'molecular chaperone', HSP-90 - page 60
CHAPTER 8 MTT AND DRUG RESISTANCE - page 62
- De novo resistance to MTTs is almost inevitable - page 62
- Using MTTs to overcome chemotherapy resistant clones - page 63
- The population-based risk assessment with empiric treatment needs to evolve to a more 'personalized' approach - page 65
CHAPTER 9 CHANGING THE PARADIGM: CANCER AS A CHRONIC DISEASE? - page 66
- Evolving maintenance therapy to prevent tumor recurrence and improve progression-free survival - page 66
- Long-term toxicities following chronic administration of MTTs - page 67
  - Long-term cardiac toxicity of Herceptin falls within the range of 'acceptability' - page 67
  - MTTs may have unique toxicity profiles - page 68
CHAPTER 10 HOW WILL LIFECYCLE MANAGEMENT STRATEGIES CHANGE WITH THE INTRODUCTION OF TARGETED TREATMENTS? - page 70
- Herceptin's logical and stepwise approach to indication expansion - page 71
  - Moving from the metastatic to adjuvant setting requires a tremendous committment of human and financial resources - page 71
  - Ground-breaking results support clinical benefit of Herceptin in the adjuvant setting - page 73
  - Ongoing LCM strategy evaluates Herceptin use in combination with antihormonals - page 75
  - Herceptin: the archetypal approach to LCM for novel MTT? - page 76
- Rituxan indication expansion from a 'niche' tumor to the backbone of treatment for B-cell malignancies - page 77
  - Off-label use in the US responsible for a significant sales growth - page 79
  - Maintenance therapy indication the next goal for Genentech/Roche - page 80
  - Rituxan indication expansion into non-malignant disease is unprecedented in the MTT era, but it should not be unique - page 80
- Avastin LCM based on data derived from randomized Phase II studies - page 81
  - Randomized Phase II approach contrasts with that of Novartis's PTK-787 (valatanib) - page 81
  - Early disappointment from results of Avastin in combination with Xeloda tempered by Horowitz trial data - page 81
  - Indication expansion beyond CRC into other tumor-types proves fruitful - page 82
  - Randomized Phase II study demonstrates Avastin activity in NSCLC and mBC - page 83
CHAPTER 11 THE PHARMACOECONOMIC CHALLENGE - page 87
- Pharamcoeconomic contraints will become increasingly more challenging - page 87
- The rising costs of mCRC pharmacotherapy are disproportionate in relation to improvements in survival - page 87
- Improved pharmacoeconomic analysis will be required to communicate the 'value' of novel MTTs - page 89
CHAPTER 12 APPENDIX - page 91
- Research methodology - page 91
- Disclaimer - page 91

List of Figures
Figure 1: Increasing combined incidence for breast, lung, prostate and colorectal cancer with increasing age - page 10
Figure 2: Predicted rise in global population aged 60 years and over - page 11
Figure 3: Global oncology sales, 2002-09 - page 12
Figure 4: Focus of R&D by therapy area - page 13
Figure 5: Predicted sales growth by therapy class, 2003-08 - page 14
Figure 6: Colorectal cancer developmental agents, 2004 - page 15
Figure 7: Unmet needs in cancer - page 18
Figure 8: The targets in signal transduction - page 21
Figure 9: The antiangiogenesis approach - page 23
Figure 10: Monoclonal antibodies in oncology - page 25
Figure 11: Small molecule drugs in oncology - page 26
Figure 12: Monotherapy with small molecule MTTs - page 27
Figure 13: Combination therapy with small molecule MTTs - page 29
Figure 14: Combination treatment with MoAbs, Part I - page 31
Figure 15: Combination treatment with MoAbs, Part II - page 32
Figure 16: Conclusions and persisting dilemmas to novel approaches with MTTs - page 34
Figure 17: The richness of targets in oncology - page 35
Figure 18: Challenges to the development of novel treatment combinations - page 36
Figure 19: Novel MTT combinations in solid tumors - page 37
Figure 20: Patient selection for Herceptin treatment - page 39
Figure 21: Patient selection according to molecular characteristics - page 41
Figure 22: EGFR mutations and response to EGFR-TKIs - page 43
Figure 23: Frequency of EGFR mutations and NSCLC, Part I - page 44
Figure 24: Frequency of EGFR mutations and NSCLC, Part II - page 44
Figure 25: Molecular characteristics of EGFR and response to treatment - page 45
Figure 26: EGFR mutations and response to EGFR-TKIs - page 46
Figure 27: Improved patient selection for anti-angiogenic treatment - page 47
Figure 28: Optimization of go/no go decisions - page 49
Figure 29: The 'Proof of Concept' paradigm shift - page 51
Figure 30: The RDT schematic - page 52
Figure 31: RDT of sorafenib (BAY 43-9006) - page 53
Figure 32: BAY 43-9006 targets both signal transduction and angiogenesis - page 54
Figure 33: Sorafenib (BAY 43-9006) RDT results - page 55
Figure 34: PFS for sorafenib (BAY 43-9006) in the RDT - page 56
Figure 35: Multi-targeted TKIs - page 57
Figure 36: How to treat cancers targeted by multiple genomic aberrations? - page 59
Figure 37: 17-AAG inhibits multiple 'mission critical' pathways - page 60
Figure 38: Resistance to novel MTTs - page 62
Figure 39: Chemotherapy-induced acquired drug resistance - page 63
Figure 40: MTTs and drug resistance - page 64
Figure 41: Changing the paradigm - cancer to become a chromic disease? - page 66
Figure 42: Cardiotoxicity of Herceptin in the adjuvant setting - page 68
Figure 43: LCM for Herceptin - page 71
Figure 44: Herceptin and docetaxel in mBC - page 72
Figure 45: Adjuvant Herceptin in breast cancer - page 73
Figure 46: Adjuvant Herceptin and improvements in DFS - page 74
Figure 47: Adjuvant Herceptin and improvements in OS - page 75
Figure 48: LCM for Rituxan - page 77
Figure 49: Rituxan - GELA trial results - page 78
Figure 50: Rituxan - Mint trial results - page 78
Figure 51: Rituxan in combination with CVP for indolent NHL - page 79
Figure 52: Maintenance Rituxan (MabThera) in indolent NHL - page 80
Figure 53: Avastin in combination with IFL improves OS in mCRC - page 82
Figure 54: Avastin improves survival in first-line treatment of NSCLC - page 83
Figure 55: Avastin improves PFS in first-line treatment of mBC - page 84
Figure 56: Avastin improves OS in first-line treatment of mBC - page 85
Figure 57: LCM of Avastin - future tumor targets - page 86
Figure 58: Improved survival in mCRC - page 88
Figure 59: The cost of mCRC treatment regimens - page 88
Figure 60: Cost evaluation study of rituximab plus MCP in follicular lymphoma - page 89
Figure 61: Conclusions from cost evaluation study of rituximab plus MCP in follicular lymphoma - page 90

Other users found this report page using the following search terms: targeted therapy kinase immunotherapy targeted cancer treatment valatanib treatments therapy oncology tarveca challenges market

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.

Optimizing Targeted Treatment in Cancer: Negotiating the Challenges to Success

Credit Card Details

Invoice Details

Table of Contents