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Stakeholder Insight: Chronic Leukemias - Is there room left for improvement?
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| Zahlen und Fakten zur Studie: |
*Understand prescribing trends and identify key factors that influence treatment choices in CLL and CML *Examine unmet need within the CLL and CML markets and identify opportunities for new product development *Enhance commercial positioning by increasing understanding of current dynamics within the CLL and CML markets 362 pages | |||||||||||
| Inhalt der Studie: |
CLL is the most common form of leukemia in western countries. Recent therapeutic advances have improved the rate and duration of remission, although there is no consensus over the optimum regimen. CM.....
CLL is the most common form of leukemia in western countries. Recent therapeutic advances have improved the rate and duration of remission, although there is no consensus over the optimum regimen. CML has a lower incidence than CLL, but is a commercially lucrative indication for Gleevec (imatinib; Novartis) which continues to enjoy blockbuster success, having revolutionized the treatment of CML. Report Highlights Rituxan (rituximab; Biogen Idec/Genentech/Roche/Zenyaku Kogyo) has received considerable off-label use for chronic lymphocytic leukemia (CLL), particularly in the US. Positive Phase III data are likely to drive increased uptake in the EU. Conversely, several factors have restricted uptake of Campath (alemtuzumab; Takeda/Genzyme/Bayer Schering). Gleevec is firmly established as the standard-of-care for newly diagnosed chronic phase CML, while the second generation tyrosine kinase inhibitors Sprycel (dasatinib; Bristol-Myers Squibb) and Tasigna (nilotinib; Novartis) are experiencing increasing uptake in Gleevec-resistant and accelerated phase patients. Sprycel currently commands a higher market share than Tasigna for CML, benefiting from its first-to-market advantage. However, physicians' perceptions of Sprycel and Tasigna show little differentiation, and there will be close competition for market share in the coming years. [Studien Infos ausblenden] |
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ABOUT DATAMONITOR HEALTHCARE 2 About the Oncology pharmaceutical analysis team 2 CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the chronic leukemias market 3 Datamonitor insight into the CLL market 3 Datamonitor insight into the CML market 4 Contributing experts 5 Related reports 6 Upcoming reports 6 CHAPTER 2 INTRODUCTION AND SCOPE 8 Coverage of the Stakeholder Insight Survey 8 Disease definition and epidemiology 8 Segmentation of the chronic leukemia population 8 Current drug treatment practice for CLL and CML 8 Key unmet needs within the CLL and CML market 9 Potential of pipeline drugs for CLL and CML 9 CHAPTER 3 COUNTRY TREATMENT TREES 10 Introduction 10 CLL country treatment trees 10 US 12 Japan 15 France 18 Germany 21 Italy 24 Spain 27 UK 30 CML country treatment trees 33 US 35 Japan 37 France 39 Germany 41 Italy 43 Spain 45 UK 47 CHAPTER 4 CLL: DISEASE OVERVIEW, EPIDEMIOLOGY AND PATIENT SEGMENTATION 49 Introduction 49 CLL is an incurable disease characterized by an accumulation of mature B-lymphocytes 49 Most CLL patients are asymptomatic at presentation 49 Etiology of CLL is poorly understood 50 Epidemiology of CLL 51 Incidence of leukemia subtypes in the seven major markets 51 CLL is the most commonly diagnosed subtype of leukemia in the seven major markets 51 Forecast incidence of CLL in the seven major markets, 2008-2017 53 Age distribution of CLL incidence rates 55 Segmentation of the CLL population 57 The Rai and Binet staging systems 57 US and Japan physicians most commonly use Rai system; EU physicians most commonly use Binet system 57 Disease stage at presentation 59 The majority of CLL patients have early-stage disease at diagnosis 59 Identification of high-risk patients 63 CHAPTER 5 CLL: TREATMENT TRENDS AND TREATMENT OUTCOMES 65 Overview of CLL treatment options 65 Summary of agents used to treat CLL 65 Key clinical trial data 67 Ribomustin/Treanda (bendamustine; Astellas/Cephalon) 67 Chlorambucil 68 Fludarabine 69 Campath (alemtuzumab; Takeda/Genzyme/Bayer Schering) 70 Rituxan/MabThera (rituximab; Biogen Idec/Genentech/Roche/Zenyaku Kogyo) 74 Summary of CLL treatment strategies 79 Physicians commonly initiate first-line treatment after a period of observation 79 First-line treatment choices depend on several factors 80 Treatment choices for relapsed CLL depend on outcome for first-line therapy 80 Treatment of refractory CLL is challenging 81 Percentage of patients receiving treatment 82 Rai Stage 0 82 The majority of Rai Stage 0 patients do not receive anti-cancer drug therapy 83 Rai Stage I-II 84 Over half of Rai Stage I-II patients receive anti-cancer treatment 85 Rai Stage III-IV 85 The majority of Rai Stage III-IV patients receive treatment immediately after diagnosis 87 Duration of observation 88 Duration of observation before initiation of treatment depends strongly on disease stage 89 First-line treatment trends 90 Use of first-line regimens by Rai Stage 90 Rai Stage 0 90 Rai Stage I-II 94 Rai Stage III-IV 98 There is no firmly established stand-of-care for first-line treatment of CLL 102 Off-label use of Rituxan-containing regimens is more common in the US than in the 5EU and Japan 104 Toxicity concerns, skepticism over the Phase III trial and limited awareness of suitable candidates for treatment have limited uptake of Campath for first-line CLL 105 Use of first-line regimens by country 107 US 108 Japan 109 France 112 Germany 114 Italy 116 Spain 118 UK 120 First-line treatment outcomes 122 Response criteria 122 Rai Stage 0 122 50% of treated Rai Stage 0 patients achieve a complete remission 125 Rai Stage I-II 126 CR rates for Rai Stage I-II correlate with the use of FCR 128 Rai Stage III-IV 129 Higher remission rates for Rai Stage III-IV CLL in the US correlate with commonplace use of FCR 131 Second-line treatment trends 132 Percentage of patients progressing to second-line therapy 132 The majority of late-stage CLL patients progress to a second-line regimen 133 Second-line regimens 134 More than half of second-line patients receive a Rituxan-containing regimen 138 Toxicity profile and low efficacy in some patients have restricted second-line uptake of Campath to modest levels 139 Second-line treatment trends by regimen prescribed initially 140 A high percentage of physicians use second-line Campath after FCR or FC 141 Second-line treatment outcomes 142 Modest treatment outcomes highlight the need for more effective second-line therapy 142 Third-line treatment trends 145 Percentage of patients progressing to third-line therapy 145 Approximately half of second-line patients progress to a third-line regimen 146 Third-line regimens 146 Single-agent Campath is the most commonly used third-line regimen, although Rituxan-based regimens are more commonly used overall 150 Third-line treatment outcomes 151 Over 40% of patients do not achieve a partial remission or complete remission after third-line therapy 151 Further lines of therapy 153 The majority of third-line patients receive no further treatment 153 CHAPTER 6 CLL: PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 155 Factors influencing prescribing decisions in CLL 155 Efficacy is the most important prescribing influence for CLL 155 Physician perception of approved and late-phase pipeline CLL therapies 156 Physicians perceive Campath to be the most effective CLL drug 158 Toxicity and safety for extended use is rated highest for Rituxan 159 Rituxan scores higher than Campath for most other attributes 159 Brand map overview of attributes and drug perception in CLL 159 Interpreting a brand map 159 CHAPTER 7 CLL: UNMET NEEDS 162 Ranking of unmet needs in CLL 162 Curative treatment is the biggest unmet need in CLL 162 CHAPTER 8 CLL: LATE-PHASE PIPELINE OVERVIEW 164 Products in Phase III development for CLL 164 Genasense (Oblimersen; Genta) 164 Drug overview 164 Key historical events 165 Datamonitor comments 167 Approval of Genasense is looking increasingly unlikely 167 Termination of agreement with Sanofi-Aventis is a major setback for Genta 168 Lumiliximab (Anti-CD23 MAb; Biogen Idec) 168 Drug overview 168 Key historical events 169 Clinical trial data 170 The addition of lumiliximab to the FCR regimen may produce a higher response rate without additional toxicity 170 Datamonitor comments 173 Lumiliximab on course to become an established addition to the standard treatment for CLL 173 Biogen Idec should look to investigate Lumiliximab as a maintenance therapy 174 Ofatumumab (HuMax-CD20; Genmab/GlaxoSmithKline) 175 Drug overview 175 Genmab hoping ofatumumab will demonstrate a preferred efficacy profile over Rituxan in the clinic 175 Key historical events 176 Clinical trial data 177 Ofatumumab receives Fast Track status for CLL and enters a Phase III trial 178 Datamonitor comments 179 Targeting underserved CLL patients may enhance ofatumumab's uptake in the market 179 CHAPTER 9 CML: DISEASE OVERVIEW, EPIDEMIOLOGY AND PATIENT SEGMENTATION 181 Introduction 181 CML is characterized by a single genetic aberration 181 CML patients are commonly asymptomatic at presentation 183 Etiology of CML is unknown 183 Epidemiology of CML 184 Incidence of leukemia subtypes in the seven major markets 184 CML is the third most commonly diagnosed subtype of leukemia in the seven major markets 184 Forecast incidence of CML in the seven major markets, 2008-2017 187 Age distribution of CML incidence rates 189 The incidence rate of CML increases with age 189 Segmentation of the CML population 191 CML has a triphasic or biphasic disease course 191 Disease stage at presentation 193 The majority of CML patients present with chronic phase disease 193 CHAPTER 10 CML: TREATMENT TRENDS AND TREATMENT OUTCOMES 195 Overview of CML treatment options 195 Summary of agents used to treat CML 195 Definition of CML treatment outcomes 196 Key CML clinical trial data 196 Gleevec (imatinib; Novartis) 196 Sprycel (dasatinib; Bristol-Myers Squibb) 199 Tasigna (nilotinib; Novartis) 205 Summary of CML treatment strategies 209 Gleevec is standard-of-care for first-line chronic phase CML but there is no firm consensus for accelerated phase or blast crisis patients 209 Options for Gleevec resistance include increasing the dose of Gleevec, switching to a second-generation TKI and stem cell transplantation 210 Treatment trends for chronic phase CML first-line therapy 211 Regimens 211 Gleevec is the firmly established standard-of-care across all seven major markets for first-line chronic phase CML 211 Dosing 213 400mg daily is by far the most-commonly used dose used for first-line Gleevec in chronic phase CML 213 First-line therapy treatment outcomes 215 Over 25% of patients who achieve complete response eventually show secondary Gleevec-resistance 217 Treatment trends for Gleevec resistance 221 Primary Gleevec resistance 221 Increasing the Gleevec dose is the most commonly used treatment approach for primary Gleevec resistance 221 Secondary Gleevec resistance 223 Switching to Sprycel or Tasigna is common for secondary Gleevec resistance 224 Use of cytogenetic testing correlates with switching from Gleevec 225 Sprycel's first-to-market advantage gives it higher market penetration than Tasigna 227 Treatment trends for accelerated phase CML 228 Percentage of patients progressing to accelerated phase CML 228 Regimens 229 High-dose Gleevec remains more popular than switching to Sprycel or Tasigna for accelerated phase CML 229 Treatment trends for blast crisis CML 233 Percentage of patients progressing to blast crisis CML 233 Regimens 235 Commonplace use of acute leukemia-type chemotherapy regimens reduces the markets' share of tyrosine kinase inhibitors for blast crisis CML 235 CHAPTER 11 CML: PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 238 Factors influencing prescribing decisions in CML 238 Efficacy is the most important prescribing influence for CML 238 Physician perception of approved and late-phase pipeline CML therapies 240 Physicians find it hard to differentiate between Gleevec, Sprycel and Tasigna in terms of efficacy 241 Gleevec judged to have the most favorable toxicity profile; Tasigna scores higher than Sprycel 242 Cost 243 Tasigna's dosing schedule is considered less convenient than Gleevec and Sprycel 244 Future-based scenarios in the CML market 245 Physicians are undecided over which second-generation tyrosine kinase inhibitor will become the most popular 245 Tasigna and Sprycel are likely to achieve increased uptake in the first-line but may not displace Gleevec as standard of care 246 Brand map overview of attributes and drug perception in CML 247 Interpreting a brand map 247 CHAPTER 12 CML: UNMET NEEDS 249 Ranking of unmet needs in CML 249 Blast crisis is the greatest area of unmet need in CML but may not be the most commercially attractive 249 Gleevec resistance remains an area of high unmet need 250 CHAPTER 13 CML: LATE-PHASE PIPELINE OVERVIEW 253 Products in Phase III development for CML 253 Bosutinib (SKI-606; Wyeth) 254 Drug overview 254 Key historical events 254 Clinical trial data 255 Bosutinib Phase II results in Gleevec-resistant/intolerant chronic phase CML 255 Bosutinib Phase II results in Gleevec-resistant/intolerant accelerated phase and blast crisis CML and Ph+ ALL 257 Datamonitor comments 259 Like the other tyrosine kinase inhibitors, bosutinib appears ineffective in patients harboring the T315I mutation - a key driver of resistance 259 Bosutinib trying to catch up with Sprycel and Tasigna in the race to replace Gleevec in the front-line setting 259 Ceflatonin (Myelostat; ChemGenex Pharmaceuticals) 260 Drug overview 260 Key historical events 261 Clinical trial data 262 Ceflatonin targeting Gleevec-resistant patients 262 Datamonitor comments 267 Despite convincing clinical benefit, Ceflatonin will face strong competition from Sprycel and Tasigna 267 BIBLIOGRAPHY 268 Journal papers 268 Websites 275 Other 277 APPENDIX A 278 Abbreviations 279 Exchange rates 281 Second-line treatment trends by regimen prescribed initially: full seven major market data 282 US 282 Japan 283 France 284 Germany 285 Italy 286 Spain 287 UK 288 Physician research methodology 289 Physician sample breakdown 289 US 289 Japan 290 France 290 Germany 291 Italy 292 Spain 293 UK 294 Contributing experts 295 APPENDIX B 296 The survey questionnaire 296 Introduction 296 Section 1 - Chronic Lymphocytic Leukemia: Patient Segmentation 296 Section 2 - Chronic Lymphocytic leukemia: Treatment 298 Section 3 - Chronic Lymphocytic Leukemia: Product Profiles / Pipeline Products 311 Section 4 - Chronic Myeloid Leukemia: Patient Segmentation 315 Section 5 - Chronic Myelogenous Leukemia: Treatment 318 Section 6 - Chronic Myelogenous Leukemia: Product Profiles / Pipeline Products 330 Demographics 333 About Datamonitor 335 About Datamonitor Healthcare 335 Disclaimer 337 Disclaimer 337 [Inhaltsverzeichnis ausblenden] |
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