Stakeholder Insight: Renal Cancer - Targeted Therapies Rapidly Take Hold Of Market

Published by: Datamonitor

Published: Oct. 15, 2007

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Oncology pharmaceutical analysis team

Andrew Paramore - Oncology Lead Analyst & Head of Product Development

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the Renal Cancer market

Related reports

Upcoming reports

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight survey

Disease definition and epidemiology

Segmentation of the renal cancer population

Current drug treatment practice for renal cancer

Key unmet needs within the renal cancer market

Potential of pipeline drugs for renal cancer

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 DISEASE OVERVIEW, EPIDEMIOLOGY AND PATIENT SEGMENTATION

Disease definition

TNM is most commonly used staging system for RCC

Etiology

Obesity accounts for 30% of RCC incidences

Smoking accounts for 20% of RCC incidences

Hypertension influences RCC risk

Family history of RCC associated with an increased risk for RCC

No conclusive evidence over occupational risk factors

Disease incidence

RCC incidence rates vary considerably across the seven major markets; RCC is more prevalent in males

RCC incidence rate increasing steadily

Incidence of RCC across seven major markets will total 86,800 in 2007

CHAPTER 5 DIAGNOSIS AND PRESENTATION IN RCC

Disease subtype at presentation

Renal cell carcinoma accounts for the majority of kidney cancer diagnoses across the seven major markets

Distribution of kidney cancer subtypes does not vary significantly across the seven major markets

Disease stage at presentation

High proportion of RCC patients treated by medical oncologists present with Stage IV disease

Higher apparent proportion of Stage IV RCC patients at diagnosis in Germany may reflect difference in referral patterns

Urologists rather than medical oncologists primarily responsible for RCC management in Japan; explains apparently higher proportion of early-stage disease in Japan

Uncertain whether screening program would significantly increase proportion of RCC diagnosed at early stage

CHAPTER 6 TREATMENT OPTIONS FOR RCC

Overview of treatment options in RCC

Overview of pharmacological therapies in RCC: targeted therapy approvals provide much-needed therapeutic option in RCC

Overview of surgery in RCC: surgery is principal treatment option for Stage I-III RCC

Trends in surgery and drug therapy in RCC across the seven major markets

High percentage of Stage I-III RCC patients receive surgery across all seven major markets

Adjuvant therapy in Stage I-III patients limited to clinical trials

Small proportion of non-surgically treated patients treated with drug therapy

Majority of Stage IV patients receive drug therapy

CHAPTER 7 TREATMENT TRENDS: FIRST-LINE DRUG REGIMENS FOR STAGE IV RCC

First-line prescribing trends in Stage IV RCC by class of drug therapy

Use of targeted therapies across seven major markets for Stage IV RCC reflects country-specific market dynamics

US: targeted therapies have already captured a large share of the market

Japan: cytokine therapy dominates RCC market in absence of approved targeted therapies

France: use of targeted therapies for RCC is highest compared to other major European healthcare markets

Italy and UK: cost-containment measures limit uptake of targeted therapies for RCC

Use of cytotoxic therapy in the first-line is highest in Germany

First-line prescribing trends in Stage IV RCC by specific drug or regimen

Sutent versus Nexavar: Sutent is most commonly prescribed first-line targeted therapy for RCC

Interferon alfa versus interleukin: interferon alfa is the most commonly prescribed cytokine therapy for first-line treatment of RCC

Avastin used off-label in the US for Stage IV RCC; likely to capture more of first-line market

Torisel may experience modest uptake for low performance status RCC patients

CHAPTER 8 TREATMENT TRENDS: SECOND-LINE AND THIRD-LINE DRUG REGIMENS IN RCC

Recurrence patterns and second-line treatment in RCC

Recurrence rates increase with disease stage at diagnosis

High proportion of Stage III and Stage IV RCC patients progress to receive a second-line drug regimen

Second-line prescribing trends in RCC by class of drug therapy

Targeted therapies are predominant class of second-line drug therapy for RCC

Second-line prescribing trends in RCC by specific drug or regimen

Nexavar and Sutent are the predominant drug therapies in second-line RCC treatment

Nexavar is preferred second-line therapy for Sutent-refractory patients

Nexavar marginally preferred over Sutent as second-line therapy in patients treated with interferon alfa or interleukin-2 as first-line therapy

Second-line use of interleukin-2 mainly accounted for by Japanese RCC patients

Avastin third most prescribed second-line drug in US, France, Germany and Spain

Gemzar is third most popular second-line therapy in Italy

Torisel likely to capture a share of second-line market in RCC

Third-line prescribing trends in RCC

Less than a third of second-line RCC patients progress to a third-line regimen

Third-line prescribing trends by specific drug or regimen

Avastin most prescribed third-line RCC therapy across the seven major markets

5-fluorouracil is favored third-line drug in Japan

CHAPTER 9 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT FOR RCC DRUG THERAPIES

Factors influencing prescribing decisions in RCC

Efficacy is the major prescribing influence in RCC

Toxicity also an important prescribing influence

Cost issues possibly not as important as for other indications

Other factors exert minor influence on RCC treatment decisions

Physician perception of existing therapies in RCC

Efficacy considered to be greatest for Sutent

Toxicity profiles most favorable for Sutent, Nexavar and Avastin

Cost: interferon alfa considered best in terms of cost issues

Convenience of administration highest for Sutent and Nexavar due to oral availability

Patient preference reflects toxicity profile

Physician familiarity highest for interleukin-2 and interferon alfa

Brand map overview of attributes and drug perception in RCC

Interpreting a brand map

CHAPTER 10 TREATMENT OUTCOMES AND UNMET NEEDS IN RCC

Treatment outcomes

Remission rates

Remission duration

Unmet needs in renal cancer

Efficacious drugs for metastatic disease is greatest unmet need in RCC

Improving treatment outcomes in RCC

Drug combinations likely to become more common in RCC

Sutent and Nexavar being investigated in adjuvant setting

CHAPTER 11 RCC LATE-PHASE PIPELINE OVERVIEW

Desired attributes of pipeline drugs in RCC

Products in Phase III development for RCC

RCC Phase III pipeline overview

Oncophage (vitespen), Antigenics

Reniale, LipoNova

TroVax (MVA 5T4), Oxford Biomedica/Sanofi Aventis

Avastin (bevacizumab), Genentech/Roche

Certican (everolimus), Novartis

Rencarex (WX-G250), Wilex

Tykerb (lapatinib), GlaxoSmithKline

Pazopanib, GlaxoSmithKline

BIBLIOGRAPHY

Journals

Websites

Other

APPENDIX A

Physician research methodology

Physician sample breakdown

US

Japan

France

Germany

Italy

Spain

UK

Contributing experts

APPENDIX B

The survey questionnaire

Section 2 - Treatment

Section 3 - Product Profiles

Section 4 - Pipeline Products

The opinion leader discussion guide

Referral and treatment in RCC

First-line drug therapy in RCC

Second-line drug therapy in RCC

Unmet needs, pipeline drugs and future treatments

Disclaimer

List of Tables

Table 1: TNM staging of RCC and associated 5-year survival rates

Table 2: Incidence rates of kidney cancer across the seven major markets, 2002

Table 3: Estimated RCC incidence across the seven major markets, 2007-17

Table 4: Breakdown of renal cancer subtypes at presentation for each of the seven major markets (%), 2007

Table 5: Percentage of RCC patients presenting with each stage of disease at first diagnosis in the seven major markets (%), 2007

Table 6: Summary of RCC drug regimens, July 2007

Table 7: Unapproved drug therapies for RCC used by physicians responding to Datamonitor renal cancer survey, 2007

Table 8: Principal surgical options for the treatment of RCC, 2007

Table 9: Percentage of Stage I-III RCC patients receiving surgery/not receiving surgery averaged across the seven major markets, 2007

Table 10: Percentage of Stage I RCC patients undergoing surgery who also receive adjuvant and/or neoadjuvant drug therapy in the seven major markets, 2007

Table 11: Percentage of Stage II RCC patients undergoing surgery who also receive adjuvant and/or neoadjuvant drug therapy in the seven major markets, 2007

Table 12: Percentage of Stage III RCC patients undergoing surgery who also receive adjuvant and/or neoadjuvant drug therapy in the seven major markets, 2007

Table 13: Percentage of non-surgically treated Stage I-III RCC patients receiving drug therapy in the seven major markets, 2007

Table 14: Percentage of Stage IV RCC patients receiving drug therapy in the seven major markets, 2007

Table 15: Percentage of Stage IV RCC patients who undergo first-line systemic therapy with each drug class in the seven major markets, 2007

Table 16: Percentage of Stage IV RCC patients who undergo first-line systemic therapy receiving each drug or regimen, in the seven major markets, 2007

Table 17: Percentage of RCC patients relapsing at each stage averaged over the seven major markets, 2007

Table 18: Disease stage at relapse for RCC patients who initially present with Stage I-III RCC averaged across the seven major markets (%), 2007

Table 19: Percentage of RCC patients initially treated with drug therapy who progress/do not progress to a second-line drug regimen averaged across the seven major markets, 2007

Table 20: Percentage of Stage III RCC patients initially treated with drug therapy who progress/do not progress to receive a second-line drug regimen in each of the seven major markets, 2007

Table 21: Percentage of Stage IV RCC patients initially treated with drug therapy who progress/do not progress to receive a second-line drug regimen in each of the seven major markets, 2007

Table 22: Percentage of RCC patients who receive second-line drug treatment with each class of drug, averaged across the seven major markets, 2007

Table 23: Percentage of RCC patients who undergo second-line drug therapy receiving each drug or regimen as a second-line treatment, in the seven major markets, 2007

Table 24: Percentage of patients who receive each drug as second-line therapy according to treatment initially received, averaged across the seven major markets, 2007

Table 25: Comparison of clinical trial data for Sutent and Nexavar in cytokine-refractory patients, 2007

Table 26: Percentage of second-line RCC patients progressing to third-line regimen in the seven major markets, 2007

Table 27: Percentage of RCC patients who undergo third-line drug therapy receiving each drug or regimen, in the seven major markets, 2007

Table 28: Relative weighting given to each prescribing influence for RCC drug therapy across the seven major markets, 2007

Table 29: Mean rating (weighted by importance of attribute) given by physicians to currently approved drugs in RCC, 2007

Table 30: Comparison of Phase III trial data for Sutent, Nexavar and Torisel in RCC

Table 31: Summary of selected clinical trials of interferon alfa and interleukin-2

Table 32: Toxicity profile comparison: most commonly reported Grade 3 or 4 adverse events in large-scale clinical trials of RCC drugs, 2007

Table 33: Comparison of estimated costs for drug treatments in RCC, 2007

Table 34: Mean percentage of RCC patients achieving remission by disease stage in the seven major markets, 2007

Table 35: Mean duration of remission (in months) for RCC patients achieving remission before relapsing in the seven major markets, 2007

Table 36: Ongoing Phase III trials of targeted therapies as adjuvant treatment following surgery in RCC, July 2007

Table 37: Drugs in Phase III development for RCC, August 2007

Table 38: US physician sample breakdown, 2007

Table 39: Japan physician sample breakdown, 2007

Table 40: France physician sample breakdown, 2007

Table 41: Germany physician sample breakdown, 2007

Table 42: Italy physician sample breakdown, 2007

Table 43: Spain physician sample breakdown, 2007

Table 44: UK physician sample breakdown, 2007

List of Figures

Figure 1: Population, treatment and treatment outcome data for RCC in the US, 2007

Figure 2: Population, treatment and treatment outcome data for RCC in US, 2007 (continued)

Figure 3: Population, treatment and treatment outcome data for RCC in Japan, 2007

Figure 4: Population, treatment and treatment outcome data for RCC in Japan, 2007 (continued)

Figure 5: Population, treatment and treatment outcome data for RCC in France, 2007

Figure 6: Population, treatment and treatment outcome data for RCC in France, 2007 (continued)

Figure 7: Population, treatment and treatment outcome data for RCC in Germany, 2007

Figure 8: Population, treatment and treatment outcome data for RCC in Germany, 2007 (continued)

Figure 9: Population, treatment and treatment outcome data for RCC in Italy, 2007

Figure 10: Population, treatment and treatment outcome data for RCC in Italy, 2007 (continued)

Figure 11: Population, treatment and treatment outcome data for RCC in Spain, 2007

Figure 12: Population, treatment and treatment outcome data for RCC in Spain, 2007 (continued)

Figure 13: Population, treatment and treatment outcome data for RCC in the UK, 2007

Figure 14: Population, treatment and treatment outcome data for RCC in the UK, 2007 (continued)

Figure 15: Relative prevalence of RCC subtypes, 2005

Figure 16: Estimated RCC incidence across the seven major markets, 2007-17

Figure 17: Breakdown of kidney cancer subtype at diagnosis averaged over the seven major markets, 2007

Figure 18: Breakdown of renal cancer subtypes at presentation for each of the seven major markets (%), 2007

Figure 19: Percentage of RCC patients presenting with each stage of disease at first diagnosis in the seven major markets, 2007

Figure 20: Timeline of recent approvals of targeted therapies for metastatic RCC, December 2005-May 2007

Figure 21: Percentage of Stage I-III RCC patients receiving surgery/not receiving surgery averaged across the seven major markets, 2007

Figure 22: Percentage of Stage I-III RCC patients not receiving surgery in each country across the seven major markets, 2007

Figure 23: Percentage of non-surgically treated Stage I-III RCC patients who receive drug therapy, seven major markets, 2007

Figure 24: Percentage of Stage IV RCC patients receiving drug therapy, in the seven major markets, 2007

Figure 25: Percentage of Stage IV RCC patients who undergo first-line systemic therapy with each drug class, in the seven major markets, 2007

Figure 26: Top three first-line drug therapies for Stage IV RCC, US, 2007

Figure 27: Top three first-line drug therapies for Stage IV RCC, Japan, 2007

Figure 28: Top three first-line drug therapies for Stage IV RCC, France, 2007

Figure 29: Top three first-line drug therapies for Stage IV RCC, Germany, 2007

Figure 30: Top three first-line drug therapies for Stage IV RCC, Italy, 2007

Figure 31: Top three first-line drug therapies for Stage IV RCC, Spain, 2007

Figure 32: Top three first-line drug therapies for Stage IV RCC, UK, 2007

Figure 33: Percentage of RCC patients relapsing at each stage averaged over the seven major markets, 2007

Figure 34: Disease stage at relapse for RCC patients who initially present with Stage I-III RCC averaged across the seven major markets (%), 2007

Figure 35: Percentage of RCC patients initially treated with drug therapy who progress/do not progress to a second-line drug regimen averaged across the seven major markets, 2007

Figure 36: Percentage of Stage III RCC patients initially treated with drug therapy who progress/do not progress to receive a second-line drug regimen in each of the seven major markets, 2007

Figure 37: Percentage of Stage IV RCC patients initially treated with drug therapy who progress/do not progress to receive a second-line drug regimen in each of the seven major markets, 2007

Figure 38: Proportion of RCC patients who receive second-line drug treatment with each class of drug at second-line, averaged across the seven major markets, 2007

Figure 39: Top three second-line drug therapies for RCC, US, 2007

Figure 40: Top three second-line drug therapies for RCC, Japan, 2007

Figure 41: Top three second-line drug therapies for RCC, France, 2007

Figure 42: Top three second-line drug therapies for RCC, Germany, 2007

Figure 43: Top three second-line drug therapies for RCC, Italy, 2007

Figure 44: Top three second-line drug therapies for RCC, Spain, 2007

Figure 45: Top three second-line drug therapies for RCC, UK, 2007

Figure 46: Correlation between first-line drug regimen and choice of second-line drug regimen in RCC, averaged across the seven major markets, 2007

Figure 47: Percentage of second-line RCC patients progressing to third-line regimen in the seven major markets, 2007

Figure 48: Top three third-line drug therapies for RCC, US, 2007

Figure 49: Top three third-line drug therapies for RCC, Japan, 2007

Figure 50: Top three third-line drug therapies for RCC, France, 2007

Figure 51: Top three third-line drug therapies for RCC, Germany, 2007

Figure 52: Top three third-line drug therapies for RCC, Italy, 2007

Figure 53: Top three third-line drug therapies for RCC, Spain, 2007

Figure 54: Top three third-line drug therapies for RCC, UK, 2007

Figure 55: Relative weighting given to each prescribing influence for RCC drug therapy across the seven major markets, 2007

Figure 56: Mean rating (weighted by importance of attribute) given by physicians to existing RCC drugs, 2007

Figure 57: Overview brand map of attributes versus brand perception in RCC, 2007

Figure 58: Mean percentage of RCC patients achieving remission by disease stage across the seven major markets, 2007

Figure 59: Mean duration of remission (in months) for RCC patients achieving remission before relapsing in the seven major markets, 2007

Figure 60: Mean physician ratings of unmet needs in renal cancer, 2007

Figure 61: Order of importance of desired clinical attributes for pipeline drugs in metastatic RCC, 2007

Figure 62: Clinical targets necessary to convince physicians to use pipeline drug instead of Sutent in first-line for RCC, 2007

Figure 63: Clinical targets necessary to convince physicians to use pipeline drug in cytokine-refractory patients in RCC, 2007

Abstract

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