Pipeline Insight: Breast Cancer - Recent approvals increase pressure on pipeline candidates

Published by: Datamonitor

Published: Apr. 17, 2008 - 187 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Oncology pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the breast cancer market

Related reports

Upcoming reports

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Pipeline overview

Products in late-phase development for breast cancer

Products in Phase II development for breast cancer

Products in Phase I development for breast cancer

Pipeline by development phase and therapy class

Molecular targeted therapies account for over 50% of all drugs in development for breast cancer

Pipeline by indication

Most trials of late-phase breast cancer drugs are in the metastatic setting

Pipeline by company

Biotech and small/mid pharma account for the majority of companies with drugs in clinical development for breast cancer

The majority of companies have a single drug in clinical development for breast cancer

The top four companies in terms of marketed and pipeline drugs for breast cancer are Novartis, AstraZeneca, Roche and Pfizer

Novartis

AstraZeneca

Pfizer

Roche

Key metrics

Datamonitor pipeline assessment summary

CHAPTER 3 BREAST CANCER - MARKET POTENTIAL

Definition of breast cancer

Anatomy of the breast

Histology of breast cancer

Segmentation of breast cancer

Staging of breast cancer

Predictive markers for breast cancer

Hormone receptor status used to predict benefit of hormonal therapy

HER-2 status is a well-established prognostic factor and is used to make therapeutic choices

Gene expression analysis will further subdivide the breast cancer population

Epidemiology of breast cancer

Incidence of breast cancer in the seven major markets

Incidence of female invasive breast cancer will total 455,000 in the seven major markets in 2008

Age distribution of breast cancer incidence rates

Mortality

Female mortality from breast cancer will total 118,000 in the seven major markets in 2008

Current breast cancer treatment options

Overview of drug therapies approved for breast cancer

Cytotoxic therapies, endocrine therapies and molecular targeted therapies form the mainstay of breast cancer drug therapy

Treatment options and treatment outcomes by disease stage

Early invasive and locally advanced disease is treated with surgery and adjuvant/neoadjuvant therapy

Metastatic breast cancer treated with intention of improving quality of life

Unmet needs in breast cancer

Agents capable of increasing overall survival are needed for metastatic breast cancer

More treatment options are needed for hormone receptor-negative and HER-2-negative patients

Treatment options for elderly patients are limited by small amount of data

More tolerable and more convenient drug therapies are needed

CHAPTER 4 R&D APPROACH

Classification of pipeline products

Cytotoxics

Endocrine therapies

Molecular targeted therapies

Single-target signal transduction inhibitors

Angiogenesis inhibitors

Apoptosis inducers

Cell cycle inhibitors

Multi-targeted inhibitors

Epigenetic modulators

Immunotherapeutic agents

Optimizing clinical trial design in breast cancer

Patient selection is important for successful development of targeted therapies in breast cancer

Clinical trial endpoints in breast cancer

Survival: progression-free survival is commonly-used as a primary endpoint for metastatic breast cancer

CHAPTER 5 CYTOTOXIC THERAPIES ANALYSIS AND FORECASTS

Overview of cytotoxic therapies

Pipeline summary

Late-phase pipeline of cytotoxic therapies

Phase II pipeline of cytotoxic therapies

Phase I pipeline of cytotoxic therapies

Comparative forecasts

Definition of current comparator therapy

Taxotere (docetaxel; Sanofi-Aventis)

Eribulin (E7389; Eisai)

Drug overview

Key historical events

Clinical development in breast cancer

Two Phase III studies are to evaluate eribulin in relapsed locally advanced and metastatic breast cancer

Phase II results show some activity and relatively low toxicity in a heavily pretreated refractory breast cancer patient population

Datamonitor comments

Eribulin will need to demonstrate considerable efficacy or toxicity benefits in the face of strong competition

Eisai could benefit from help of company with more experience of the breast cancer market

Forecasts to 2017

Larotaxel (XRP-9881; Sanofi-Aventis)

Drug overview

Key historical events

Clinical development in breast cancer

Phase III trial shows that larotaxel has no superiority over Xeloda in terms of response rate in progressive metastatic breast cancer

Larotaxel confers a 19% response rate in taxane-resistant metastatic breast cancer in a Phase II study

Earlier Phase II results show larotaxel confers greater activity in taxane non-resistant patients, but at the expense of high toxicity

Datamonitor comments

Failure to show superiority over Xeloda has dented prospects of larotaxel as a single agent

Too early to predict clinical potential of combinations of larotaxel

Genericization of taxanes will further limit larotaxel's commercial potential

CHAPTER 6 ENDOCRINE THERAPIES ANALYSIS AND FORECASTS

Overview of endocrine therapies

Pipeline summary

Late-phase pipeline of endocrine therapies

Phase II pipeline of endocrine therapies

Phase I pipeline of endocrine therapies

Arzoxifene (LY-353381; Eli Lilly)

Drug overview

Key historical events

Clinical development in breast cancer

Arzoxifene has inferior efficacy to tamoxifen in Phase III study

Datamonitor comments

Disappointing Phase III trial results mean that arzoxifene is unlikely to reach the market as a breast cancer treatment

CHAPTER 7 MOLECULAR TARGETED THERAPIES ANALYSIS AND FORECASTS

Overview of molecular targeted therapies

Pipeline summary

Late-phase pipeline of molecular targeted therapies

Phase II pipeline of molecular targeted therapies

Phase I pipeline of molecular targeted therapies

Comparative forecasts

Definition of current comparator therapy

Herceptin (trastuzumab; Genentech/Roche/Chugai)

Armala (pazopanib; GlaxoSmithKline)

Drug overview

Key historical events

Clinical development in breast cancer

Phase III study will evaluate combination of Armala and Tykerb as a second-line therapy in HER-2-positive inflammatory breast cancer patients

Datamonitor comments

Armala could satisfy significant unmet need in inflammatory breast cancer, but this indication has a very limited patient potential

Lack of Phase II data makes it difficult to comment on activity of Armala in breast cancer

The combination of Armala and Tykerb could be too costly for some healthcare markets

Forecasts to 2017

Certican (Everolimus, RAD-001; Novartis)

Drug overview

Key historical events

Clinical development in breast cancer

Phase III study will evaluate Certican and paclitaxel as one of six regimens in the neoadjuvant setting

Combination of Certican and Femara shows promise in the neoadjuvant setting for ER-positive breast cancer

Early Phase II data show that Certican has some activity as a single agent in metastatic breast cancer

Datamonitor comments

Certican will have to significantly improve treatment outcomes in order to ensure uptake in the neoadjuvant setting

Limited amount of Phase II data makes it difficult to assess clinical potential of Certican in metastatic breast cancer

Novartis's oncology marketing presence and experience of the breast cancer market will increase Certican's chances of success

Forecasts to 2017

Omnitarg (pertuzumab; Genentech/Roche/Chugai)

Drug overview

Key historical events

Clinical development in breast cancer

Phase III study is evaluating the combination of Omnitarg, Herceptin and Taxotere as a first-line treatment for HER-2-positive metastatic breast cancer

Phase II study suggests that combination of Herceptin plus Omnitarg has activity in progressive metastatic breast cancer previously treated with Herceptin

Omnitarg has limited activity as a single agent in metastatic breast cancer with low HER-2 expression

Datamonitor comments

Clinical benefit will have to outweigh increased cost of adding Omnitarg to Herceptin

Uncertain whether Omnitarg will be developed for HER-2-negative population

Forecasts to 2017

Sutent (sunitinib; Pfizer)

Drug overview

Key historical events

Clinical development in breast cancer

Extensive development program shows Pfizer's bold ambitions for Sutent in the breast cancer market

Four ongoing Phase III trials are evaluating Sutent as a treatment for metastatic breast cancer

Single-agent Sutent is active in heavily pretreated metastatic breast cancer patients

Datamonitor comments

Sutent will compete with Avastin in the HER-2-negative metastatic breast cancer population

Sutent could have a competitive edge over other small-molecule targeted therapies in the late-phase breast cancer pipeline

Forecasts to 2017

Axitinib (AG-013736; Pfizer)

Drug overview

Key historical events

Clinical development in breast cancer

Randomized Phase II trial suggests combination of axitinib and Taxotere has promising efficacy in metastatic breast cancer

Datamonitor comments

Axitinib could struggle to compete against Avastin but may have significant potential in subset of patients previously treated with adjuvant therapy

Pfizer appears to be prioritizing the development of Sutent over the development of axitinib in breast cancer

CHAPTER 8 IMMUNOTHERAPIES AND GENE THERAPIES

Overview of Immunotherapies and gene therapies

Pipeline summary

Phase II pipeline of immunotherapies and gene therapies

Phase I pipeline immunotherapies therapies

APPENDIX

Bibliography

List of figures

List of abbreviations

Methodology

Datamonitor forecast methodology

Epidemiology forecasts

Product forecasts

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

About the Disease Analysis Team

Disclaimer

List of Tables

Table 1: Late-phase pipeline for breast cancer, 2008

Table 2: Phase II pipeline for breast cancer, 2008

Table 3: Phase I pipeline for breast cancer, 2008

Table 4: Number of pipeline drugs for breast cancer by therapy class and phase of development, 2008

Table 5: Treatment settings under investigation in ongoing Phase I-III clinical trials of drugs in late-phase development for breast cancer, 2008

Table 6: Companies with three or more drugs in clinical development for breast cancer, 2008

Table 7: Novartis's marketed cancer portfolio, 2008

Table 8: Novartis's portfolio of marketed and pipeline drugs for breast cancer, 2008

Table 9: AstraZeneca's marketed cancer portfolio, 2008

Table 10: AstraZeneca's portfolio of marketed and pipeline drugs for breast cancer, 2008

Table 11: Pfizer's marketed cancer portfolio, 2008

Table 12: Pfizer's portfolio of marketed and pipeline drugs for breast cancer, 2008

Table 13: Roche's marketed oncology portfolio, 2008

Table 14: Roche's portfolio of marketed and pipeline drugs for breast cancer, 2008

Table 15: Late-phase breast cancer products sales forecasts in the seven major markets ($m), 2008-2017

Table 16: Crude female invasive breast cancer incidence rates (per 100,000 persons) in the seven major markets, 2002

Table 17: Forecast incidence of invasive female breast cancer in the seven major markets, 2002-17

Table 18: Crude female breast cancer mortality rates (per 100,000 persons) in the seven major markets, 2002

Table 19: Forecast mortality from breast cancer in the seven major markets, 2002 and 2008

Table 20: Approved cytotoxic therapies for breast cancer in the seven major markets, March 2008

Table 21: Approved endocrine therapies for breast cancer in the seven major markets, March 2008

Table 22: Approved molecular targeted therapies for breast cancer in the seven major markets, March 2008

Table 23: Summary of treatment outcomes for adjuvant drug regimens in Stage I-III breast cancer

Table 24: Summary of treatment outcomes for neoadjuvant drug regimens in Stage I-III breast cancer

Table 25: Summary of treatment outcomes for drug regimens in Stage IV breast cancer

Table 26: Late-phase pipeline cytotoxic therapies in breast cancer, 2008

Table 27: Phase II pipeline cytotoxic therapies in breast cancer, 2008

Table 28: Phase I pipeline cytotoxic therapies in breast cancer, 2008

Table 29: Forecasting assumptions for late-phase cytotoxic therapies in the seven major pharmaceutical markets, 2008

Table 30: Taxotere: key facts

Table 31: Eribulin: key historical events

Table 32: Ongoing clinical trials involving eribulin in breast cancer, 2008

Table 33: Eisai's oncology portfolio, 2008

Table 34: Forecasting assumptions for Eribulin in the seven major pharmaceutical markets, 2008 (1 of 2)

Table 35: Forecasting assumptions for Eribulin in the seven major pharmaceutical markets, 2008 (2 of 2)

Table 36: Eribulin sales forecast for third-line therapy in locally recurrent and metastatic breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Table 37: Larotaxel: key historical events

Table 38: Ongoing clinical trials involving larotaxel in breast cancer, 2008

Table 39: Late-phase endocrine therapies in breast cancer, 2008

Table 40: Phase II endocrine therapies in breast cancer, 2008

Table 41: Phase I endocrine therapies in breast cancer, 2008

Table 42: Arzoxifene: Key historical events

Table 43: Late-phase molecular targeted therapies in breast cancer, 2008

Table 44: Phase II molecular targeted therapies in breast cancer, 2008

Table 45: Phase I molecular targeted therapies in breast cancer, 2008

Table 46: Forecasting assumptions for MTTs in the seven major pharmaceutical markets, 2008 (1 of 2)

Table 47: Forecasting assumptions for MTTs in the seven major pharmaceutical markets, 2008 (2 of 2)

Table 48: Herceptin: key facts

Table 49: Armala: Key historical events

Table 50: Ongoing clinical trials involving Armala in breast cancer, 2008

Table 51: Forecasting assumptions for Armala in the seven major pharmaceutical markets, 2008 (1 of 2)

Table 52: Forecasting assumptions for Armala in the seven major pharmaceutical markets, 2008 (2 of 2)

Table 53: Armala sales forecast in second-line, HER-2-positive inflammatory breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Table 54: Certican: Key historical events

Table 55: Ongoing clinical trials involving Certican in breast cancer, 2008

Table 56: Forecasting assumptions for Certican in the seven major pharmaceutical markets, 2008 (1 of 2)

Table 57: Forecasting assumptions for Certican in the seven major pharmaceutical markets, 2008 (2 of 2)

Table 58: Certican sales forecast for neoadjuvant therapy in Stage I-III breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Table 59: Omnitarg: key historical events

Table 60: Ongoing clinical trials involving Omnitarg in breast cancer, 2008

Table 61: Forecasting assumptions for Omnitarg in the seven major pharmaceutical markets, 2008 (1 of 2)

Table 62: Forecasting assumptions for Omnitarg in the seven major pharmaceutical markets, 2008 (2 of 2)

Table 63: Omnitarg sales forecast for first-line therapy in HER-2-positive metastatic breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Table 64: Sutent: key historical events

Table 65: Ongoing clinical trials involving Sutent in breast cancer, 2008

Table 66: Forecasting assumptions for Sutent in the seven major pharmaceutical markets, 2008 (1 of 2)

Table 67: Forecasting assumptions for Sutent in the seven major pharmaceutical markets, 2008 (2 of 2)

Table 68: Sutent sales forecast for metastatic and advanced breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Table 69: Axitinib: Key historical events

Table 70: Phase II immunotherapies and gene therapies in breast cancer, 2008

Table 71: Phase I immunotherapies and gene therapies in breast cancer, 2008

Table 72: Abbreviations used in Pipeline Insight: Breast Cancer

Table 73: Datamonitor drug assessment parameters

List of Figures

Figure 1: Number of pipeline drugs for breast cancer by therapy class and phase of development, 2008

Figure 2: Treatment settings under investigation in ongoing clinical trials of drugs in late-phase development, 2008

Figure 3: Breast cancer pipeline by type of company, 2008

Figure 4: Segmentation of companies according to number of drugs in breast cancer pipeline, 2008

Figure 5: Companies with three or more drugs in clinical development for breast cancer, 2008

Figure 6: Number of marketed and pipeline drugs for breast cancer by stage of development for Novartis, AstraZeneca, Roche and Pfizer, 2008

Figure 7: Late-phase breast cancer products sales forecasts in the seven major markets ($m), 2008-2017

Figure 8: Clinical and commercial attractiveness of late-phase cytotoxic therapies in breast cancer, 2008

Figure 9: Clinical and commercial attractiveness of late-phase molecular targeted therapies in breast cancer, 2008

Figure 10: The human female breast

Figure 11: Histological classification of breast cancer

Figure 12: Definitions used for breast cancer classification with TNM staging system

Figure 13: TNM staging system for breast cancer

Figure 14: Molecular biomarkers used in breast cancer

Figure 15: Forecast incidence of invasive female breast cancer in the seven major markets, 2002-2017

Figure 16: Distribution of breast cancer incidence rates by age group, US, 2000-04

Figure 17: Forecast mortality from breast cancer in the seven major markets, 2002 and 2008

Figure 18: Summary of unmet needs in the breast cancer market, 2008

Figure 19: Clinical and commercial attractiveness of late-phase cytotoxic therapies in breast cancer, 2008

Figure 20: Late-phase cytotoxic therapies sales forecasts in breast cancer in the seven major markets ($m), 2008-2017

Figure 21: Phase III trial evaluating eribulin versus Xeloda in recurrent locally advanced or metastatic breast cancer

Figure 22: EMBRACE Phase III trial evaluating eribulin versus investigators' choice of therapy in recurrent locally advanced or metastatic breast cancer

Figure 23: Phase II results for eribulin monotherapy in chemotherapy-refractory advanced breast cancer patients

Figure 24: Eribulin sales forecast for third-line therapy in locally recurrent and metastatic breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Figure 25: Phase III trial comparing Larotaxel to Xeloda in progressing metastatic breast cancer

Figure 26: Phase II study investigating larotaxel in previously treated metastatic breast cancer

Figure 27: Phase III trial comparing arzoxifene to tamoxifen for locally advanced or metastatic breast cancer

Figure 28: Clinical and commercial attractiveness of late-phase molecular targeted therapies in breast cancer, 2008

Figure 29: Late-phase molecular targeted therapies sales forecasts in breast cancer in the seven major markets ($m), 2008-2017

Figure 30: Phase III trial evaluating Armala and Tykerb in HER-2-positive inflammatory breast cancer

Figure 31: Armala sales forecast in second-line, HER-2-positive inflammatory breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Figure 32: Phase III trial of Certican, Avastin and Tykerb in the neoadjuvant setting

Figure 33: Results of Phase II trial of Certican plus Femara as a neoadjuvant breast cancer therapy

Figure 34: Results of Phase II study of Certican monotherapy in metastatic breast cancer

Figure 35: Certican sales forecast for neoadjuvant therapy in Stage I-III breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Figure 36: Phase III study of Omnitarg plus Herceptin plus Taxotere in HER-2-positive metastatic breast cancer

Figure 37: Phase II results for Omnitarg plus Herceptin in progressive HER-2-positive metastatic breast cancer

Figure 38: Phase II results of Omnitarg monotherapy in previously treated metastatic breast cancer patients with low HER-2 expression

Figure 39: Omnitarg sales forecast for first-line therapy in HER-2-positive metastatic breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Figure 40: Phase III trial of Sutent plus paclitaxel in first-line HER-2-negative metastatic breast cancer

Figure 41: Phase III trial of Sutent plus Taxotere in locally recurrent or metastatic breast cancer

Figure 42: Phase III trial of Sutent plus Xeloda in locally advanced or metastatic breast cancer

Figure 43: Phase III trial of single-agent Sutent in second-line locally recurrent or metastatic breast cancer

Figure 44: Phase II results of Sutent monotherapy in progressive metastatic breast cancer

Figure 45: Sutent sales forecast for metastatic and advanced breast cancer in the seven major pharmaceutical markets ($m), 2008-2017

Figure 46: Results of randomized Phase II study of axitinib plus Taxotere in metastatic breast cancer

Figure 47: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

Abstract

Introduction

Incidence of breast cancer in the seven major markets will total 455,000 in 2008, while 115,000 women will die from the disease. Despite advances in treatment over the past decade, significant unmet needs remain. This level of demand and the large patient potential make breast cancer a relatively attractive indication for drug developers.

Scope

• Examination of the breast cancer pipeline with in-depth clinical and commercial profiles of Phase III candidates
• Seven major pharmaceutical sales forecasts for Phase III pipeline products through to 2017 with product-specific assumptions
• Segmentation and analysis of the current breast cancer pipeline by developmental phase, drug class, company and indication
• Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs

Report Highlights

• There are 121 drugs in clinical development for breast cancer. Molecular targeted therapies are the predominant therapy class in the breast cancer pipeline, accounting for 50% of the pipeline. Cytotoxic therapies account for 25% of the pipeline, while therapeutic vaccines account for 13%, and endocrine therapies account for just 6% of the pipeline.
• Seven drugs are in late-phase development for breast cancer, of which four are molecular targeted therapies. Collectively, the late-phase pipeline candidates are forecast to achieve $2,230m in sales in 2017 in the seven major pharmaceutical markets. The late-phase molecular targeted therapies account for the majority of this with sales of $2,142m.
• The majority (82%) of clinical trials of drugs in late-phase development for breast cancer are in the metastatic setting. This reflects the higher level of unmet need, lower bar to market entry and shorter trial completion time as compared with the adjuvant or neoadjuvant treatment setting.

Reasons to Purchase

• Identify key drugs and companies involved in the breast cancer pipeline based on sales forecasts to 2017 and Datamonitor drug assessment
• Understand what the key hurdles to commercial and clinical success are for drugs in late-phase development for breast cancer
• Characterize unmet need and poorly served patient subsets within breast cancer and assess the potential for pipeline products to provide satisfaction

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