Pipeline Insight: Breast Cancer - A diverse and increasingly crowded pipeline
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the oncology pharmaceutical analysis team - page 2
- Richard Faint - Director of Oncology - page 2
- About the oncology pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Overview of Pipeline Insight: Breast cancer - page 3
- Datamonitor insight into the breast cancer market - page 4
- Rising incidence of breast cancer among women aged over 50 will expand the market over the coming decade - page 5
- The breast cancer pipeline is diverse with seven novel candidates undergoing Phase III development - page 5
- The arrival of Tykerb will herald a new era for HER-2 positive, Herceptin-refractory locally advanced and metastatic breast tumor patients - page 7
- Genentech/Roche will dominate the molecular targeted therapeutics class with Avastin likely to become a breast cancer blockbuster by 2012 - page 8
- Theratope, Advexin and tesmilifene have limited commercial potential - page 8
- CHAPTER 2 PIPELINE OVERVIEW AND FUTURE FOCUS - page 12
- Pipeline overview: seven novel candidates are undergoing Phase III breast cancer development - page 12
- Signal transduction inhibitors dominate the breast cancer targeted therapy pipeline, with the majority in Phase II trials - page 19
- Over 100 companies are involved in the breast cancer pipeline - page 20
- An overview to the two leading companies in terms of marketed and pipeline breast cancer products - page 21
- AstraZeneca's leading breast cancer portfolio is under pressure because of impending patent expiries - page 21
- Genentech's breast cancer portfolio continues to grow from strength to strength - page 23
- An overview to the two leading companies in terms of marketed and pipeline breast cancer products - page 21
- CHAPTER 3 DISEASE OVERVIEW - page 25
- Definition of breast cancer - page 25
- Four anatomical types of breast cancer exist - page 26
- Ductal carcinoma in situ (DCIS): the most common form of non-invasive breast cancer - page 26
- Lobular carcinoma in situ (LCIS) rarely develops into invasive disease - page 27
- Paget's disease is predominately associated with invasive disease - page 27
- Male breast cancer accounts for 1% of all breast carcinomas - page 27
- Genetics of breast cancer - page 27
- Diagnosis of breast cancer - page 28
- There are a number of prognostic factors for breast cancer - page 28
- Hormone receptor status - page 28
- Lymph node involvement - page 29
- Histologic grade - page 29
- HER-2/neu status - page 29
- S-phase status - page 29
- The American Joint Committee on Cancer's TNM staging system is typically used to segment breast cancer - page 30
- Four anatomical types of breast cancer exist - page 26
- Epidemiology of breast cancer - page 31
- Breast cancer remains the most common cancer among women worldwide - page 31
- Standard treatment options are based primarily upon disease stage - page 35
- Stage I: breast-conserving surgery forms the mainstay of treatment - page 35
- Stage II: the use of systemic therapy is dependent upon a number of factors - page 36
- Stage III: because of the involvement of lymph nodes, adjuvant systemic therapy is crucial - page 36
- Stage IV: as treatment largely forms palliative purposes, antihormonal therapies are preferred to the cytotoxics - page 37
- Overview of current drug therapy options - page 37
- Adjuvant treatment options are varied - page 37
- Chemotherapy is recommended regardless of hormone receptor status - page 38
- Tamoxifen remains the standard hormone treatment of adjuvant breast cancer - page 41
- Treatment of advanced disease - page 43
- Adjuvant treatment options are varied - page 37
- Unmet needs in breast cancer are significant - page 48
- Effective treatment for metastatic disease still remains elusive - page 49
- A wider range of treatment options is required for hormone receptor-negative patients - page 50
- Elderly patients remain an underserved population - page 51
- Stage III patients represent a missed opportunity - page 51
- More convenient and better tolerated treatments are needed - page 52
- Earlier diagnosis via mammography is improving prognosis but screening awareness must remain - page 52
- Definition of breast cancer - page 25
- CHAPTER 4 R&D APPROACH - page 54
- The breast cancer pipeline is divided into five major drug classes - page 54
- Cytotoxic drugs lack specificity - page 54
- Optimizing current treatment strategies is paramount - page 55
- Antihormonal or endocrine therapy provides incremental benefit in selected tumors - page 55
- The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy - page 55
- Signal transduction inhibitors destroy target pathways leading to tumor proliferation - page 56
- Angiogenesis inhibitors target tumors by reducing vascular blood supply - page 56
- Apoptosis inducers compensate for aberrations in cell surveillance - page 57
- Cell cycle inhibitors have recently been the focus of cancer research - page 57
- Multi-tyrosine kinase inhibitors are growing in importance - page 58
- Antisense oligonucleotide uses DNA technology to create highly specific therapeutics - page 58
- Immunotherapy-based treatments are a novel highly specialized anti tumor group - page 59
- A small number of agents have miscellaneous modes of action - page 59
- Optimizing clinical trial design in breast cancer - page 60
- Enhanced patient selection is vital for successful development of targeted therapies - page 60
- With the majority of approved breast cancer drugs targeting the adjuvant setting, less commercialization incentives exist - page 61
- Clinical trial endpoints in breast cancer - page 61
- Survival is the key endpoint of breast cancer trials - page 61
- Tumor response rate is an intermediate endpoint often overlooked - page 62
- Time to tumor progression is becoming increasingly popular - page 63
- Toxicity issues will remain a key factor in the clinical development of novel breast cancer agents - page 63
- Quality of life is a secondary endpoint with major importance in the palliative setting - page 64
- Standardized oncology vaccine endpoints remain undetermined - page 65
- The breast cancer pipeline is divided into five major drug classes - page 54
- CHAPTER 5 CYTOTOXICS LATE-STAGE DRUG ANALYSIS & FORECASTS - page 66
- Just two cytotoxics are in Phase III breast cancer trials - page 66
- Pipeline summary - page 66
- Sonus Pharmaceuticals' Tocosol paclitaxel (vitamin-E paclitaxel reformulation) - page 67
- Profile - page 67
- Tocosol paclitaxel is a cremophor-free Vitamin-E based formulation - page 67
- Clinical trial data - page 68
- Phase I Tocosol paclitaxel trial shows potential as a novel breast cancer agent - page 69
- Phase IIb trial demonstrates over seven month progression-free survival without Grade 4 non-hematological adverse effects - page 70
- Tocosol paclitaxel potential patient population may be reduced in cost-constrained markets - page 74
- Schering AG licensing deal will prove vital to raise Tocosol paclitaxel's profile - page 74
- Profile - page 67
- Sanofi-Aventis' XRP-9881 - page 75
- Profile - page 75
- XRP-9881 has been in Phase III development for breast cancer since 2004 - page 75
- Clinical trial data - page 76
- Phase II trial demonstrates XRP-9881 has a greater survival benefit in taxane non-resistant breast tumors than taxane-resistant breast tumors - page 77
- XRP-9881's toxicity profile may limit its patient population - page 78
- Sanofi-Aventis must increase awareness of XRP-9881 - page 79
- Profile - page 75
- Eisai's E7389 - page 80
- Profile - page 80
- E7389: an anti-tubulin derived from marine sponge claimed to be active in patients refractory to other tubulin-targeting agents - page 80
- Eisai's E-7389 shows 15% response in Phase II refractory advanced breast cancer - page 80
- E7389 21-day cycle efficacy and safety data is required to realize the therapeutics' full patient potential - page 83
- Eisai must seek a licensing collaboration to maximize E789 potential outside of Japan to compensate for a lack of oncology marketing experience - page 83
- Profile - page 80
- Pierre Fabre/Bristol-Myers Squibb's Javlor (vinflunine) - page 84
- Profile - page 84
- Javlor is a vinca alkaloid undergoing Phase II breast cancer trials - page 84
- Clinical trial data - page 84
- Datamonitor is unable to determine Javlor's patient potential as overall survival data remains elusive - page 87
- Pierre Fabre was wise to choose Bristol-Myers Squibb over GlaxoSmithKline as Javlor's marketing partner - page 87
- Profile - page 84
- Schering AG's ZK-EPO - page 88
- Profile - page 88
- ZK-EPO is a novel epothilone-derivative microtubule stabilizer with the potential to overcome drug resistance - page 88
- ZK-EPO has good toxicity profile in advanced solid refractory antineoplastic breast tumors - page 88
- ZK-EPO could hold potential as a first-line metastatic agent to prevent drug resistance - page 89
- Schering AG impending merger with Bayer will ensure a promising future for ZK-EPO if approval is gained - page 89
- Profile - page 88
- Comparison of key cytotoxic agents - page 90
- XRP-9881 is anticipated to become the leading cytotoxic of those in late-stage breast cancer development - page 90
- Datamonitor's drug assessment model shows Tocosol paclitaxel has the greatest research, clinical and commercial potential of the novel cytotoxics - page 92
- Just two cytotoxics are in Phase III breast cancer trials - page 66
- CHAPTER 6 ANTIHORMONAL DRUG ANALYSIS & FORECASTS - page 95
- Overview of antihormonal drugs - page 95
- Just two antihormonal agents are in Phase III development within the breast cancer market - page 95
- Definition of current comparator therapy - page 95
- AstraZeneca's Arimidex (anastrozole): Datamonitor's antihormonal comparator compound - page 95
- The ATAC trial demonstrates Arimidex's superiority over tamoxifen in the adjuvant setting - page 96
- Arimidex first-line therapy in post-menopausal metastatic breast cancer women - page 97
- Second-line Arimidex in post-menopausal women with tamoxifen-refractory metastatic breast cancer - page 97
- AstraZeneca's Arimidex (anastrozole): Datamonitor's antihormonal comparator compound - page 95
- Eli Lilly's arzoxifene (LY-353381) - page 99
- Profile - page 99
- Drug overview - page 99
- Phase IB breast cancer prevention trial demonstrates a 6% decrease in estrogen receptor expression - page 100
- Phase II breast cancer preventative study - page 100
- Phase II arzoxifene fails to statistically improve trial endpoints in locally advanced/metastatic breast tumor patients - page 101
- Arzoxifene has a significant commercialization opportunity thanks to targeting osteoporotic women at high risk of breast cancer - page 102
- Lilly must use its marketing strengths to maximize arzoxifene's uptake - page 103
- Profile - page 99
- Intarcia Therapeutics' atamestane (Biomed-777) - page 103
- Profile - page 103
- Intarcia's atamestane has a turbulent developmental history within the breast cancer arena - page 103
- There is a dearth of early-phase atamestane trial data - page 105
- Phase III atamestane plus toremifene trial fails to meet endpoint - page 105
- Intarcia drops atamestane breast cancer program and is in talks with various companies hoping to continue development - page 106
- Profile - page 103
- Comparison of key antihormonal agents - page 107
- Arzoxifene is expected to become the leading novel antihormonal, as atamestane's role within breast cancer appears doubtful - page 107
- Arzoxifene scores reasonably well in terms of commercial and clinical attractiveness - page 109
- Overview of antihormonal drugs - page 95
- CHAPTER 7 MOLECULAR TARGETED THERAPIES DRUG ANALYSIS & FORECASTS - page 111
- Numerous molecular targeted therapies are in late-stage breast cancer development - page 111
- Definition of current comparator therapy - page 112
- Genentech/Roche's Herceptin (trastuzumab) - page 112
- Herceptin monotherapy demonstrates almost 13 months median survival - page 113
- Herceptin in combination with chemotherapy doubles response rates, with time to disease progression over six months - page 114
- Early stage HER-2 positive adjuvant Herceptin FDA approval looks likely by Q3 2006 - page 116
- Nine-week adjuvant Herceptin Finnish study finds reduced cardiotoxicity - page 120
- Herceptin: currently the sole MTT within the breast cancer market - page 121
- Herceptin sales go from strength to strength with US 2005 sales growing over 50% to reach almost $750m - page 121
- Cardiotoxicity problems could challenge Herceptin's optimization of market uptake - page 122
- The cost of Herceptin continues to cause controversy, especially within the UK - page 123
- Genentech/Roche's Herceptin (trastuzumab) - page 112
- GlaxoSmithKline's Tykerb/Tycerb (lapatinib) - page 125
- Profile - page 125
- Tykerb/Tycerb is expected to file with the FDA and EMEA during H2 2006 following positive Phase III data - page 125
- Clinical trial data - page 127
- Tykerb shows promise for the treatment of refractory inflammatory HER-2 positive breast tumors with a 62% response rate - page 128
- Disappointing HER-2 positive brain metastases trial suggests Tykerb may not penetrate the blood-brain-barrier as well as previously believed - page 128
- Phase II first-line HER-2 positive, locally advanced (IIIB/IIIC) or metastatic Tykerb trial demonstrates over 45% stable disease - page 129
- Phase II trial finds Tykerb leads to four month progression-free survival in over 20% of Herceptin-refractory metastatic breast tumors - page 129
- Advanced solid HER-1/HER-2 positive tumors trial supports the use of Tykerb - page 130
- Phase III study announced at ASCO 2006 demonstrates Tykerb plus capecitabine leads to 49% reduction in the risk of tumor progression, but is associated with cardiac toxicities - page 131
- Tykerb's dual ERB targeting mechanism will lead to a significant patient potential - page 132
- GlaxoSmithKline's limited oncology portfolio will be bolstered by the arrival of Tykerb - page 134
- Profile - page 125
- Genentech/Roche's Avastin (bevacizumab) - page 135
- Profile - page 135
- Avastin: the first anti-angiogenic agent to gain approval in cancer - page 135
- Clinical trial data - page 137
- Phase I/II trial demonstrates Avastin's potential within metastatic breast cancer - page 138
- Phase II trial data finds Avastin is associated with severe hypertension - page 139
- Phase III trials show the addition of Avastin to paclitaxel doubles progression free survival in the first-line setting of locally recurrent/metastatic disease - page 139
- Avastin plus capecitabine Phase III study fails to improve survival in relapsed metastatic breast cancer patients - page 141
- Avastin's patient potential is significant because of its first-line locally advanced/metastatic target - page 143
- The approval of Avastin for breast cancer could see Genentech/Roche dominating the arena - page 144
- Profile - page 135
- OSI Pharmaceuticals/Genentech/Roche's Tarceva (erlotinib) - page 145
- Profile - page 145
- Tarceva: the HER1/EGFR approved lung cancer drug is under Phase II breast cancer development - page 145
- Clinical trial data - page 146
- A number of Phase I trials show Tarceva has potential as a breast cancer agent - page 147
- Phase II Tarceva and gemcitabine trial proves disappointing with a high patient drop-out rate, despite six-month survival of 75% - page 149
- Tarceva plus bevacizumab proves disappointing - page 150
- Tarceva plus docetaxel Phase II trial finds one-year 70% overall survival rate - page 151
- Tarceva's patient potential could be limited by treatment withdrawals - page 151
- Experience of Tarceva within the NSCLC market will push the agent ahead of other competitors - page 152
- Profile - page 145
- Millennium Pharmaceuticals/Johnson & Johnson's Velcade (bortezomib) - page 152
- Profile - page 152
- Velcade: the first ubiquitin proteosome reversible enzyme inhibitor is in Phase II breast cancer development - page 152
- Clinical trial data - page 153
- Phase I studies demonstrate Velcade - docetaxel combination is well tolerated in advanced breast cancer - page 154
- Phase II trials reveal second-line Velcade in metastatic patients proves disappointing - page 155
- Velcade's future within the breast cancer market looks uncertain - page 155
- Johnson & Johnson experience will be required to maximize Velcade profits if approval is gained - page 156
- Profile - page 152
- AstraZeneca's Iressa (gefitinib) - page 156
- Profile - page 156
- Despite the FDA's label warning and restricted access for NSCLC patients, Iressa continues Phase II breast cancer development - page 156
- Clinical trial data - page 158
- Single-agent Iressa Phase II trial supports finding that tamoxifen-resistance may be linked to increased EGFR signaling - page 159
- A further Phase II single-agent Iressa trial finds lower clinical benefit within ER-negative patients - page 159
- Iressa with paclitaxel and carboplatin warrants further investigation - page 161
- Iressa with docetaxel duo leads to over 70% disease control in metastatic breast cancers - page 161
- Iressa with docetaxel Phase II locally advanced breast cancer trial halted after unexpected hepatic toxicities - page 162
- The future of Iressa within breast cancer looks uncertain - page 163
- AstraZeneca must turn around Iressa's declining sales by combining the EGFR-inhibitor with antihormonal agents - page 163
- Profile - page 156
- Pfizer's Sutent (sunitinib) - page 164
- Profile - page 164
- Sutent is the first oncology therapeutic to be awarded dual FDA approval - page 164
- Ongoing Phase II second-line Sutent trial in metastatic breast cancer finds encouraging preliminary results - page 165
- Sutent could significantly strengthen Pfizer's oncology portfolio. - page 166
- Profile - page 164
- Pfizer's AG-013736 - page 167
- Profile - page 167
- AG-013736 Phase II breast cancer development continues despite Pfizer halting renal cell carcinoma development - page 167
- Phase I trial finds AG-013736's dose-limiting toxicities include hypertension, hemoptysis and stomatitis - page 167
- Phase I/II results support AG-013736's potential as novel multi-tyrosine kinase inhibitor - page 168
- AG-013736 could follow in the footsteps of Sutent's RCC development - page 170
- Profile - page 167
- Telik's Telcyta (TLK286, canfosfamide) - page 170
- Profile - page 170
- Telcyta: a small molecule prodrug with dual antitumor activity developed using Telcyta's TRAP technology - page 170
- Initial Phase II Telcyta data finds almost 50% disease stabilization in metastatic breast tumors - page 171
- Third-line metastatic setting of breast-cancer patients who relapse following anthracycline and taxane-based treatment could benefit greatly from Telcyta - page 172
- A Telik-Roche partnership deal would bolster Telcyta's profile - page 172
- Profile - page 170
- Bionovo' BZL101 (scutellaria barbata) - page 173
- Profile - page 173
- BLZ101: Bionovo's co-lead pipeline candidate is an aqueous extract that induces apoptosis - page 173
- BLZ101 demonstrates six-month disease stabilization in almost 20% of patients but fails to meet RECIST criteria for a partial response - page 173
- BLZ101's patient population is difficult to assess - page 174
- Bionovo's search for a commercial partner must be stepped up - page 174
- Profile - page 173
- AstraZeneca's AZD-2171 - page 175
- Profile - page 175
- AZD-2171 is one of a series of VEGF inhibitors in development by AstraZeneca - page 175
- Clinical trial data - page 175
- AZD-2171 may be a suitable future alternative to Iressa for AstraZeneca within the breast cancer arena - page 177
- Profile - page 175
- Comparison of key molecular targeted therapies - page 178
- Avastin looks set to dominate the breast cancer market becoming a blockbuster by 2009 - page 178
- Tykerb and Avastin have significant commercial attractiveness - page 180
- CHAPTER 8 MISCELLANEOUS LATE-STAGE DRUG ANALYSIS & FORECASTS - page 184
- Overview for miscellaneous late-stage drugs - page 184
- Three miscellaneous agents are in late-stage breast cancer development - page 184
- Introgen Therapeutics' Advexin (AD5CMV-p53/ INGN-201) - page 185
- Profile - page 185
- Advexin is designed on the basis that over half of all tumors contain a mutated p53 tumor suppressor gene - page 185
- Clinical trial data - page 186
- Phase I monotherapy trial demonstrates Advexin's favorable safety profile - page 186
- Phase II neoadjuvant Advexin in combination with docetaxel and doxorubicin study led to over 50% reduction in tumor size in all patients - page 187
- Advexin must demonstrate improved patient survival to impact the neoadjuvant breast cancer market - page 187
- Without Aventis' backing, Introgen will struggle to commercialize Advexin - page 188
- Profile - page 185
- YM Biosciences' tesmilifene - page 188
- Profile - page 188
- Tesmilifene Phase III breast cancer development continues with interim analysis expected soon - page 188
- Clinical trial data - page 189
- Early-stage trials warrant a combination of tesmilifene plus doxorubicin - page 189
- First Phase III tesmilifene plus doxorubicin trial halted after failure to reach study endpoint, despite improving overall survival by 50%, and toxicity concerns - page 190
- Tesmilifene's patient potential is difficult to judge - page 193
- YM Biosciences may struggle to raise tesmillifene's profile - page 193
- Profile - page 188
- Biomira's Theratope (Sianyl-Tn combined with keyhole limpet hemocyanin) - page 194
- Profile - page 194
- Theratope Phase II development continues despite commercial viability doubts following failure of its Phase III metastatic breast cancer trial - page 194
- Clinical trial data - page 195
- Theratope with cyclophosphamide pre-treatment shows promise - page 195
- Theratope, high-dose chemotherapy and autologous stem cell rescue demonstrates a favorable toxicity profile - page 195
- Bridging trial finds Theratope to have enhanced efficacy and safety than previous trials - page 196
- Data Safety Monitoring Board (DSMB) advises Phase III trial should continue - page 196
- As the first potential breast cancer vaccine, Theratope must show excellent survival rates to impact the market - page 197
- Biomira could be harmed by negative publicity surrounding Theratope within the breast cancer market - page 198
- Profile - page 194
- Comparison of key miscellaneous agents - page 199
- Difficulties in the commercialization of miscellaneous agents account for low sales forecasts - page 199
- Datamonitor's drug assessment model finds the miscellaneous agents have low clinical/research and commercialization potential - page 201
- Overview for miscellaneous late-stage drugs - page 184
- APPENDIX A - page 203
- Methodology - page 203
- Datamonitor forecast methodology - page 203
- Epidemiology forecasts - page 203
- Product forecasts - page 203
- Datamonitor drug assessment summary - page 203
- Datamonitor forecast methodology - page 203
- Contributing experts - page 207
- Bibliography - page 208
- List of tables - page 222
- List of figures - page 223
- Methodology - page 203
- APPENDIX B - page 224
- About Datamonitor - page 224
- About Datamonitor Healthcare - page 224
- Datamonitor Healthcare's therapy area capabilities - page 225
- About the Oncology analysis team - page 226
- Disclaimer - page 227
- About Datamonitor - page 224
- List of Tables
- Table 1: Overview of the breast cancer pipeline by developmental stage - page 9
- Table 2: Phase III pipeline compounds for breast cancer, 2006 - page 12
- Table 3: Phase II pipeline compounds for breast cancer, 2006 (1 of 3) - page 13
- Table 4: Phase II pipeline compounds for breast cancer, 2006 (2 of 3) - page 14
- Table 5: Phase II pipeline compounds for breast cancer, 2006 (3 of 3) - page 15
- Table 6: Phase I pipeline compounds for breast cancer, 2006 (1 of 2) - page 16
- Table 7: Phase I pipeline compounds for breast cancer, 2006 (2 of 2) - page 17
- Table 8: Approved drugs seeking label extensions undergoing Phase III breast cancer trials - page 18
- Table 9: Approved drugs seeking label extensions undergoing Phase II trials - page 19
- Table 10: Breast cancer pipeline targeted therapies by developmental phase and class of drug, 2006 - page 20
- Table 11: AstraZeneca's marketed oncology portfolio, 2006 - page 21
- Table 12: AstraZeneca's breast cancer pipeline oncology portfolio, 2006 - page 22
- Table 13: Genentech's marketed oncology portfolio, 2006 - page 23
- Table 14: Genentech's breast pipeline oncology portfolio, 2006 - page 24
- Table 15: American Joint Committee on Cancer TNM staging of breast cancer - page 30
- Table 16: American Joint Committee on Cancer TNM staging of breast cancer - page 31
- Table 17: Crude incidence rates of female breast cancer per 100,000 in the seven major markets, 2002 - page 32
- Table 18: Female breast cancer incidence forecast in the seven major markets, 2002-16 - page 33
- Table 19: Stage-specific incidence of female breast cancer in the seven major markets, 2006 - page 34
- Table 20: NCCN adjuvant guidelines for breast cancer - page 38
- Table 21: NCCN-recommended adjuvant/first-line breast cancer non-trastuzumab chemotherapy combinations (1 of 2) - page 39
- Table 22: NCCN-recommended adjuvant/first-line breast cancer non-trastuzumab chemotherapy combinations (2 of 2) - page 40
- Table 23: NCCN-recommended adjuvant /first-line breast cancer trastuzumab chemotherapy combinations - page 41
- Table 24: NCCN-recommended post-menopausal hormonal therapy options for breast cancer - page 44
- Table 25: NCCN-recommended single-agent treatment of advanced breast cancer - page 45
- Table 26: NCCN-recommended combined- agent treatment of advanced breast cancer - page 46
- Table 27: Currently marketed FDA-approved branded therapeutics indicated for metastatic breast cancer - page 47
- Table 28: Approved dosing schedules for Herceptin - page 48
- Table 29: Five-year relative survival rate by disease stage at diagnosis - page 49
- Table 30: Key cytotoxic products in the Phase III/II breast cancer pipeline, 2006 - page 66
- Table 31: Summary of key Tocosol paclitaxel breast cancer clinical trials - page 69
- Table 32: Tocosol paclitaxel Phase IIb trial data - page 70
- Table 33: Single-agent Taxotere, Taxol and Abraxane Phase III metastatic breast cancer trial data: efficacy - page 72
- Table 34: Tocosol Phase IIb trial: toxicity profile - page 73
- Table 35: Ongoing XRP-9881 breast cancer clinical trials, 2006 - page 76
- Table 36: Summary of key XRP- 9881 breast cancer clinical trials - page 76
- Table 37: XRP-9881 Phase II efficacy data for taxane-resistant (RS) and taxane non-resistant (NRS) metastatic breast tumors - page 77
- Table 38: XRP-9881 Phase II Grade 3-4 toxicity results for taxane-resistant (RS) and non-taxane resistant (NRS) metastatic breast tumors - page 78
- Table 39: E7389 Phase II refractory advanced breast cancer trial: efficacy results (n=65) - page 81
- Table 40: E7389 Phase II refractory advanced breast cancer trial: safety results (n=48) - page 82
- Table 41: Javlor efficacy results following prior taxane treatment - page 85
- Table 42: Javlor efficacy in treating visceral and liver metastases following taxane treatment - page 86
- Table 43: Second-line Javlor Phase II trial in metastatic anthracycline & taxane-refractory breast cancer: safety results (n=60) - page 86
- Table 44: Cytotoxic agents sale forecast assumptions - page 90
- Table 45: Key breast cancer pipeline cytotoxic sales forecasts, 2006-16 ($m) - page 90
- Table 46: Research/clinical attractiveness and commercial attractiveness summary for pipeline cytotoxics - page 92
- Table 47: Key antihormonal agents in the Phase III breast cancer pipeline, 2006 - page 95
- Table 48: Phase II arzoxifene locally advanced/metastatic breast cancer results: efficacy - page 102
- Table 49: Ongoing atamestane breast cancer clinical trials, 2006 - page 104
- Table 50: Antihormonal sale forecast assumptions - page 107
- Table 51: Key breast cancer pipeline antihormonal sales forecasts, 2006-16 ($m) - page 108
- Table 52: Research/clinical attractiveness and commercial attractiveness summary for pipeline antihormonals - page 109
- Table 53: Key MTT products in the Phase III/II breast cancer pipeline, 2006 - page 111
- Table 54: Genentech/Roche's Herceptin: key facts - page 113
- Table 55: Herceptin monotherapy Phase III trial: results - page 114
- Table 56: Herceptin plus chemotherapy Phase III trial: results - page 115
- Table 57: Combined analysis of NSABP B-31 and NCCTG N9831 trials - page 117
- Table 58: HERA clinical trial: results - page 120
- Table 59: Herceptin, Rituxan & Avastin US sales, 2004-2005 & Q1 2005-Q1 2006 ($m) - page 122
- Table 60: Ongoing Tykerb/Tycerb clinical trials, 2006 - page 126
- Table 61: Summary of key Tykerb/Tycerb breast cancer clinical trials - page 127
- Table 62: Tykerb/Tycerb Phase II Herceptin resistant, metastatic breast cancer trial results (n=41) - page 130
- Table 63: Ongoing Avastin breast cancer clinical trials, 2006 - page 137
- Table 64: Summary of key Avastin breast cancer clinical trials - page 138
- Table 65: E2100 Avastin breast cancer clinical trial: survival results - page 140
- Table 66: E2100 Avastin breast cancer clinical trial: toxicity results - page 141
- Table 67: Avastin plus capecitabine Phase III trial: results - page 142
- Table 68: Ongoing Tarceva breast cancer clinical trials, 2006 - page 146
- Table 69: Summary of key Tarceva breast cancer clinical trials - page 147
- Table 70: Tarceva plus bevacizumab Phase II breast cancer trial: best response results - page 150
- Table 71: Ongoing Velcade breast cancer clinical trials, 2006 - page 153
- Table 72: Summary of key Velcade breast cancer clinical trials - page 154
- Table 73: Ongoing Iressa breast cancer clinical trials, 2006 - page 157
- Table 74: Summary of key Iressa breast cancer clinical trials - page 158
- Table 75: Phase II breast cancer trials of single-agent Iressa presented at ASCO 2003 - page 159
- Table 76: Single-agent Iressa Phase II breast cancer trial by hormone-status - page 160
- Table 77: Iressa plus docetaxel Phase II first-line metastatic breast cancer results for ≥ 1 cycle - page 162
- Table 78: Ongoing Sutent breast cancer clinical trials, 2006 - page 165
- Table 79: Docetaxel plus AG-013736 or placebo Phase II trial: preliminary combined toxicity results Grade 3-4 ≥ 10% (n=61) - page 169
- Table 80: Docetaxel plus AG-013736 or placebo Phase II trial: preliminary combined hematologic toxicity results Grade 3-4 (n=60) - page 169
- Table 81: Ongoing AZD-2171 breast cancer clinical trials, 2006 - page 175
- Table 82: AZD-2171 Phase I advanced solid tumor trial: safety data - page 176
- Table 83: Molecular targeted therapies sale forecast assumptions - page 178
- Table 84: Molecular targeted therapies sale forecast assumptions - page 178
- Table 85: Key breast cancer pipeline molecular targeted therapies sales forecasts, 2006-16 ($m) - page 179
- Table 86: Research/clinical attractiveness and commercial attractiveness summary for pipeline molecular targeted therapies - page 181
- Table 87: Research/clinical attractiveness and commercial attractiveness summary for pipeline molecular targeted therapies - page 181
- Table 88: Key immunotherapy/miscellaneous products in the Phase III/II breast cancer pipeline, 2006 - page 184
- Table 89: Summary of key Advexin breast cancer clinical trials - page 186
- Table 90: Tesmilifene's Phase I-II breast cancer trial results - page 190
- Table 91: Phase III tesmilifene metastatic/recurrent breast cancer trial: efficacy results - page 191
- Table 92: Phase III tesmilifene metastatic/recurrent breast cancer trial: Grade 3-4 adverse effects of patients in either arm - page 192
- Table 93: Theratope plus hormonal therapy Phase III subset results - page 197
- Table 94: Miscellaneous agents sales forecast assumptions - page 199
- Table 95: Key breast cancer pipeline miscellaneous sales forecasts, 2006-16 ($m) - page 199
- Table 96: Research/clinical attractiveness and commercial attractiveness summary for pipeline miscellaneous agents - page 201
- Table 97: Datamonitor drug assessment parameters - page 204
- List of Figures
- Figure 1: Datamonitor drug assessment summary for all key breast cancer pipeline candidates - page 10
- Figure 2: Breast cancer pipeline targeted therapies by developmental phase and class of drug, 2006 - page 20
- Figure 3: Breast cancer pipeline by company, 2006 - page 21
- Figure 4: Anatomy of the breast - page 26
- Figure 5: Female breast cancer incidence forecast in the seven major markets, 2002-16 - page 33
- Figure 6: Stage-specific incidence of female breast cancer in the seven major markets, 2006 - page 35
- Figure 7: NCCN-recommended adjuvant hormonal therapy for invasive breast cancer - page 42
- Figure 8: NCCN guidelines for drug treatment of Stage IV breast cancer - page 43
- Figure 9: Unmet needs in the breast cancer market - page 48
- Figure 10: Sonus' Tocosol paclitaxel technology - page 67
- Figure 11: Key breast cancer pipeline cytotoxic sales forecasts, 2006-16 ($m) - page 91
- Figure 12: Drug assessment summary for the key breast cancer pipeline cytotoxics - page 93
- Figure 13: Key breast cancer pipeline antihormonal sales forecasts, 2006-16 ($m) - page 108
- Figure 14: Drug assessment summary for the key breast cancer pipeline antihormonals - page 110
- Figure 15: Herceptin monotherapy Phase III trial: design - page 113
- Figure 16: Herceptin plus chemotherapy Phase III trial: design - page 115
- Figure 17: NSABP B-31 and NCCTG N9831 clinical trials: design - page 117
- Figure 18: HERA trial: design - page 119
- Figure 19: Phase III Tykerb plus capecitabine versus capecitabine alone trial: design - page 131
- Figure 20: E2100 Avastin breast cancer clinical trial: design - page 140
- Figure 21: AG-013736 plus docetaxel Phase I/II trial: design - page 168
- Figure 22: Telcyta's mechanism of action - page 171
- Figure 23: BLZ101 Phase I/II metastatic breast cancer trial: design - page 173
- Figure 24: Key breast cancer pipeline molecular targeted therapies sales forecasts, 2006-16 ($m) - page 179
- Figure 25: Drug assessment summary for the key breast cancer pipeline molecular targeted therapies - page 182
- Figure 26: Phase III tesmilifene metastatic/recurrent breast cancer trial: design - page 191
- Figure 27: Key breast cancer pipeline miscellaneous sales forecasts, 2006-16 ($m) - page 200
- Figure 28: Drug assessment summary for the key breast cancer pipeline miscellaneous agents - page 202
- Figure 29: Example of Datamonitor drug assessment scorecard - page 205
- Figure 30: Example of Datamonitor drug assessment graph - page 206
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