Skip to content

Contact +44 (0) 20 7060 7474 email us

Cancer

Stakeholder Insight: Chronic Leukemias

Is there room left for improvement?

Publication Date November 2008
Publisher Datamonitor
Product Type Report
Pages 362
ISBN Number not applicable
Product Code DAT01650

Price

£5,285.00
approximately: $8,002 | €5,899

pdf

Buy Now

print £8,050 ($12,189 | €8,985)

Buy Now

Order above formats by FAX

Order by Fax

Summary

Introduction

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.

Scope

  • *Analysis of CLL and CML market based on a survey of 180 chronic leukemia specialists, supported by interviews carried out with key opinion leaders
  • *Segmentation of CLL and CML population by disease stage at presentation and proportion receiving anti-cancer therapy
  • *In-depth analysis of treatment patterns, regimens prescribed and treatment outcomes for CLL and CML by line of therapy and disease stage
  • *Ranking of key prescribing influences in CLL and CML, brand assessment of existing drug therapies, unmet needs and late-phase pipeline overview

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.

Reasons to Purchase

  • *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

Contents

  • Chapter 1 Executive Summary
    • Scope of the analysis
    • Datamonitor insight into the chronic leukemias market
    • Datamonitor insight into the CLL market
    • Datamonitor insight into the CML market
    • Contributing experts
    • Related reports
    • Upcoming reports
  • Chapter 2 Introduction and Scope
    • Coverage of the Stakeholder Insight Survey
    • Disease definition and epidemiology
    • Segmentation of the chronic leukemia population
    • Current drug treatment practice for CLL and CML
    • Key unmet needs within the CLL and CML market
    • Potential of pipeline drugs for CLL and CML
  • Chapter 3 Country Treatment Trees
    • Introduction
    • CLL country treatment trees
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • CML country treatment trees
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
  • Chapter 4 Cll: Disease Overview, Epidemiology and Patient Segmentation
    • Introduction
    • CLL is an incurable disease characterized by an accumulation of mature B-lymphocytes
    • Most CLL patients are asymptomatic at presentation
    • Etiology of CLL is poorly understood
    • Epidemiology of CLL
    • Incidence of leukemia subtypes in the seven major markets
    • CLL is the most commonly diagnosed subtype of leukemia in the seven major markets
    • Forecast incidence of CLL in the seven major markets, 2008-2017
    • Age distribution of CLL incidence rates
    • Segmentation of the CLL population
    • The Rai and Binet staging systems
    • US and Japan physicians most commonly use Rai system; EU physicians most commonly use Binet system
    • Disease stage at presentation
    • The majority of CLL patients have early-stage disease at diagnosis
    • Identification of high-risk patients
  • Chapter 5 Cll: Treatment Trends and Treatment Outcomes
    • Overview of CLL treatment options
    • Summary of agents used to treat CLL
    • Key clinical trial data
    • Ribomustin/Treanda (bendamustine; Astellas/Cephalon)
    • Chlorambucil
    • Fludarabine
    • Campath (alemtuzumab; Takeda/Genzyme/Bayer Schering)
    • Rituxan/MabThera (rituximab; Biogen Idec/Genentech/Roche/Zenyaku Kogyo)
    • Summary of CLL treatment strategies
    • Physicians commonly initiate first-line treatment after a period of observation
    • First-line treatment choices depend on several factors
    • Treatment choices for relapsed CLL depend on outcome for first-line therapy
    • Treatment of refractory CLL is challenging
    • Percentage of patients receiving treatment
    • Rai Stage 0
    • The majority of Rai Stage 0 patients do not receive anti-cancer drug therapy
    • Rai Stage I-II
    • over half of Rai Stage I-II patients receive anti-cancer treatment
    • Rai Stage III-IV
    • The majority of Rai Stage III-IV patients receive treatment immediately after diagnosis
    • Duration of observation
    • Duration of observation before initiation of treatment depends strongly on disease stage
    • First-line treatment trends
    • Use of first-line regimens by Rai Stage
    • Rai Stage 0
    • Rai Stage I-II
    • Rai Stage III-IV
    • There is no firmly established stand-of-care for first-line treatment of CLL
    • off-label use of Rituxan-containing regimens is more common in the US than in the 5EU and Japan
    • 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
    • Use of first-line regimens by country
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • First-line treatment outcomes
    • Response criteria
    • Rai Stage 0
    • 50% of treated Rai Stage 0 patients achieve a complete remission
    • Rai Stage I-II
    • CR rates for Rai Stage I-II correlate with the use of FCR
    • Rai Stage III-IV
    • Higher remission rates for Rai Stage III-IV CLL in the US correlate with commonplace use of FCR
    • Second-line treatment trends
    • Percentage of patients progressing to second-line therapy
    • The majority of late-stage CLL patients progress to a second-line regimen
    • Second-line regimens
    • More than half of second-line patients receive a Rituxan-containing regimen
    • Toxicity profile and low efficacy in some patients have restricted second-line uptake of Campath to modest levels
    • Second-line treatment trends by regimen prescribed initially
    • A high percentage of physicians use second-line Campath after FCR or FC
    • Second-line treatment outcomes
    • Modest treatment outcomes highlight the need for more effective second-line therapy
    • Third-line treatment trends
    • Percentage of patients progressing to third-line therapy
    • Approximately half of second-line patients progress to a third-line regimen
    • Third-line regimens
    • Single-agent Campath is the most commonly used third-line regimen, although Rituxan-based regimens are more commonly used overall
    • Third-line treatment outcomes
    • over 40% of patients do not achieve a partial remission or complete remission after third-line therapy
    • Further lines of therapy
    • The majority of third-line patients receive no further treatment
  • Chapter 6 Cll: Prescribing Influences and Brand Assessment
    • Factors influencing prescribing decisions in CLL
    • Efficacy is the most important prescribing influence for CLL
    • Physician perception of approved and late-phase pipeline CLL therapies
    • Physicians perceive Campath to be the most effective CLL drug
    • Toxicity and safety for extended use is rated highest for Rituxan
    • Rituxan scores higher than Campath for most other attributes
    • Brand map overview of attributes and drug perception in CLL
    • Interpreting a brand map
  • Chapter 7 Cll: Unmet Needs
    • Ranking of unmet needs in CLL
    • Curative treatment is the biggest unmet need in CLL
  • Chapter 8 Cll: Late-Phase Pipeline Overview
    • Products in Phase III development for CLL
    • 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
    • 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
    • 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
    • Datamonitor comments
    • Targeting underserved CLL patients may enhance ofatumumab's uptake in the market
  • Chapter 9 Cml: Disease Overview, Epidemiology and Patient Segmentation
    • Introduction
    • CML is characterized by a single genetic aberration
    • CML patients are commonly asymptomatic at presentation
    • Etiology of CML is unknown
    • Epidemiology of CML
    • Incidence of leukemia subtypes in the seven major markets
    • CML is the third most commonly diagnosed subtype of leukemia in the seven major markets
    • Forecast incidence of CML in the seven major markets, 2008-2017
    • Age distribution of CML incidence rates
    • The incidence rate of CML increases with age
    • Segmentation of the CML population
    • CML has a triphasic or biphasic disease course
    • Disease stage at presentation
    • The majority of CML patients present with chronic phase disease
  • Chapter 10 Cml: Treatment Trends and Treatment Outcomes
    • Overview of CML treatment options
    • Summary of agents used to treat CML
    • Definition of CML treatment outcomes
    • Key CML clinical trial data
    • Gleevec (imatinib; Novartis)
    • Sprycel (dasatinib; Bristol-Myers Squibb)
    • Tasigna (nilotinib; Novartis)
    • Summary of CML treatment strategies
    • Gleevec is standard-of-care for first-line chronic phase CML but there is no firm consensus for accelerated phase or blast crisis patients
    • Options for Gleevec resistance include increasing the dose of Gleevec, switching to a second-generation TKI and stem cell transplantation
    • Treatment trends for chronic phase CML first-line therapy
    • Regimens
    • Gleevec is the firmly established standard-of-care across all seven major markets for first-line chronic phase CML
    • Dosing
    • 400mg daily is by far the most-commonly used dose used for first-line Gleevec in chronic phase CML
    • First-line therapy treatment outcomes
    • over 25% of patients who achieve complete response eventually show secondary Gleevec-resistance
    • Treatment trends for Gleevec resistance
    • Primary Gleevec resistance
    • Increasing the Gleevec dose is the most commonly used treatment approach for primary Gleevec resistance
    • Secondary Gleevec resistance
    • Switching to Sprycel or Tasigna is common for secondary Gleevec resistance
    • Use of cytogenetic testing correlates with switching from Gleevec
    • Sprycel's first-to-market advantage gives it higher market penetration than Tasigna
    • Treatment trends for accelerated phase CML
    • Percentage of patients progressing to accelerated phase CML
    • Regimens
    • High-dose Gleevec remains more popular than switching to Sprycel or Tasigna for accelerated phase CML
    • Treatment trends for blast crisis CML
    • Percentage of patients progressing to blast crisis CML
    • Regimens
    • Commonplace use of acute leukemia-type chemotherapy regimens reduces the markets' share of tyrosine kinase inhibitors for blast crisis CML
  • Chapter 11 Cml: Prescribing Influences and Brand Assessment
    • Factors influencing prescribing decisions in CML
    • Efficacy is the most important prescribing influence for CML
    • Physician perception of approved and late-phase pipeline CML therapies
    • Physicians find it hard to differentiate between Gleevec, Sprycel and Tasigna in terms of efficacy
    • Gleevec judged to have the most favorable toxicity profile; Tasigna scores higher than Sprycel
    • Cost
    • Tasigna's dosing schedule is considered less convenient than Gleevec and Sprycel
    • Future-based scenarios in the CML market
    • Physicians are undecided over which second-generation tyrosine kinase inhibitor will become the most popular
    • Tasigna and Sprycel are likely to achieve increased uptake in the first-line but may not displace Gleevec as standard of care
    • Brand map overview of attributes and drug perception in CML
    • Interpreting a brand map
  • Chapter 12 Cml: Unmet Needs
    • Ranking of unmet needs in CML
    • Blast crisis is the greatest area of unmet need in CML but may not be the most commercially attractive
    • Gleevec resistance remains an area of high unmet need
  • Chapter 13 Cml: Late-Phase Pipeline Overview
    • Products in Phase III development for CML
    • Bosutinib (SKI-606; Wyeth)
    • Drug overview
    • Key historical events
    • Clinical trial data
    • Bosutinib Phase II results in Gleevec-resistant/intolerant chronic phase CML
    • Bosutinib Phase II results in Gleevec-resistant/intolerant accelerated phase and blast crisis CML and Ph+ ALL
    • Datamonitor comments
    • like the other tyrosine kinase inhibitors, bosutinib appears ineffective in patients harboring the T315I mutation - a key driver of resistance
    • Bosutinib trying to catch up with Sprycel and Tasigna in the race to replace Gleevec in the front-line setting
    • Ceflatonin (Myelostat; ChemGenex Pharmaceuticals)
    • Drug overview
    • Key historical events
    • Clinical trial data
    • Ceflatonin targeting Gleevec-resistant patients
    • Datamonitor comments
    • despite convincing clinical benefit, Ceflatonin will face strong competition from Sprycel and Tasigna
    • BIBLIOGRAPHY
    • Journal papers
    • Websites
    • Other
    • APPENDIX A
  • List of Tables
  • List of Figures
    • Abbreviations
    • Exchange rates
    • Second-line treatment trends by regimen prescribed initially: full seven major market data
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • Physician research methodology
    • Physician sample breakdown
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • Contributing experts
  • Appendix B
    • The survey questionnaire
    • Introduction
    • Section 1 - Chronic Lymphocytic Leukemia: Patient Segmentation
    • Section 2 - Chronic Lymphocytic leukemia: Treatment
    • Section 3 - Chronic Lymphocytic Leukemia: Product Profiles / Pipeline Products
    • Section 4 - Chronic Myeloid Leukemia: Patient Segmentation
    • Section 5 - Chronic Myelogenous Leukemia: Treatment
    • Section 6 - Chronic Myelogenous Leukemia: Product Profiles / Pipeline Products
    • Demographics
    • about Datamonitor
    • about Datamonitor Healthcare
    • Disclaimer
    • Disclaimer