Pipeline Insight: Non-Small Cell Lung Cancer

Summary

Introduction

Non-small cell lung cancer accounts for about 80% of all lung cancers. In 2008, the incidence of NSCLC is forecast to exceed 367,000 new cases in the seven major pharmaceutical markets. The high incidence of the disease and the large unmet need make NSCLC an attractive market for new drug development.

Scope

Research and analysis of the NSCLC pipeline with in-depth clinical and commercial assessment of Phase III candidates

Seven major pharmaceutical market sales forecasts to 2017 for key pipeline candidates incorporating product specific assumptions and events

Segmentation and analysis of the current NSCLC pipeline by developmental phase, drug class and developer

Analysis of the NSCLC market potential, including identification of unmet needs, commercial opportunities, and key trends in development

Report Highlights

Datamonitor has identified 104 drugs in the NSCLC pipeline, 15% of which are in late-phase development. Collectively, these late-phase products have a forecast sales potential of up to $4,056m by 2017 in the seven major pharmaceutical markets.

Molecular targeted therapies are the focus of R&D in NSCLC, accounting for 60% of the entire pipeline. Of the molecular targeted therapies in late-phase development, Erbitux (cetuximab; ImClone/Merck Serono/Bristol-Myers Squibb) is forecast to achieve the highest level of sales, with $473m by 2017.

The current late-phase pipeline is unlikely to satisfy the high level of unmet need in the treatment of NSCLC. However, pipeline drugs are still likely to realize notable uptake, despite offering only incremental improvements in efficacy or toxicity.

Reasons to Purchase

Acquire a detailed appreciation and impartial perspective of the NSCLC pipeline

Identify the key products in late-phase development based on sales forecasts to 2017 and Datamonitor's drug assessment methodology

Identify opportunities and risks influencing R&D in NSCLC, unmet needs in the treatment of the disease, and trends in current development

Contents

• Chapter 1 Executive Summary
  • Scope of The Analysis
  • Datamonitor Insight into The Nsclc Market
  • Related Reports
  • Upcoming Reports
• Chapter 2 Pipeline Overview and Dynamics
  • Pipeline Overview
  • Drugs in Late-Phase Development for Nsclc
  • Drugs in Phase Ii Development for Nsclc
  • Drugs in Phase I Development for Nsclc
  • Pipeline by Development Phase and Therapy Class
  • There Are over 100 Drugs in The Nsclc Pipeline, More than Half of Which Are Molecular Targeted Therapies
  • Pipeline by Mode of Action
  • Pipeline Drugs Have Diverse Modes of Action
  • Pipeline by Indication
  • The Majority of Drugs Are Being Investigated in The First-Line Treatment of Advanced Disease
  • Pipeline by Company
  • Nearly 100 Different Companies or Institutions Are Involved in The Nsclc Pipeline
  • Merck Serono Is The Only Company with Two Drugs in Phase Iii Development for Nsclc
  • Top Three Companies in Terms of The Number of Nsclc Pipeline Candidates Are Pfizer, Novartis and Bristol-Myers Squibb
  • Pfizer
  • Novartis
  • Bristol Myers Squibb
  • Key Metrics
  • Datamonitor Pipeline Assessment Summary
• Chapter 3 Non-Small Cell Lung Cancer - Market Potential
  • Definition of Nsclc
  • Non-Small Cell Lung Cancer Accounts for about 80% of All Lung Cancers
  • Three Major Types of Nsclc Exist
  • Staging of Nsclc Is Usually Based on The Ajcc Tumor Node Metastases (Tnm) Staging System
  • A Revised Staging System May Have Treatment Implications in The Future
  • The Nsclc Market Is Segmented According to Disease Stage
  • Risk Factors in The Development of Nsclc
  • Overview of Nsclc Treatment
  • The Treatment of Early-Stage Disease (Stages I-Iiia)
  • The Management of Early-Stage Disease Is Largely Based on Surgery
  • Adjuvant Chemotherapy May Benefit A Subset of Patients with Early-Stage Disease
  • Radiotherapy Has A Central Role in The Treatment of Unresectable Early-Stage Disease
  • The Treatment of Advanced Disease (Stages Iiib-Iv)
  • Chemoradiotherapy Is The Standard of Care in Patients with Unresectable Stage Iiib Disease
  • A Recent Trial Has Generated Controversy regarding The Use of Consolidation Chemotherapy in Unresectable Stage Iii Disease
  • Systemic Platinum-Based Chemotherapy Has A Central Role in The Management of Advanced Disease
  • The Addition of Avastin May Offer An Added Advantage for A Subset of Patients
  • A Number of Options Are Available for Previously-Treated Patients
  • The Role of Targeted Therapies in The Treatment of Nsclc
  • Avastin Is Extensively Used in The First-Line Setting, but Only A Subset of Patients Is Eligible for Treatment
  • off-Label Use of Tarceva Is Taking Place in The First-Line Setting
  • Astrazeneca Will Be Seeking Eu Approval for Iressa in The Second-Line Setting
  • Targeted Therapies May Find An Application in A Number of Settings in Nsclc
  • The Treatment of Nsclc Is Moving into An Era of Individualized Medicine
  • The Epidemiology of Nsclc
  • There Will Be More than 380,000 New Cases of Nsclc in The Seven Major Markets in 2017
  • Mortality from Nsclc Is High
  • Nsclc Is Predominantly A Disease of The Elderly
  • Adenocarcinoma Has Become The Most Common Histological Subtype of Nsclc
  • Asia Will Face A Major Epidemic of Lung Cancer in The Future
  • Nsclc Incidence and Mortality Rates Are Still Increasing in Women
  • Nsclc in Never-Smokers May Become More Prevalent in The Future
  • Increased Detection by Screening Is Unlikely to Affect Nsclc Incidence
  • Nsclc Is An Attractive Market for New Product Development
  • Unmet Need in Nsclc
  • Effective Treatments Are Required for Both Advanced and Early-Stage Disease
  • Nsclc Needs to Be Recognized as A Heterogeneous Disease
  • Less Toxic Treatments for Poor Performance Status Patients Are Required
  • The Treatment of Nsclc Is in Need of An Overall Refinement
• Chapter 4 R&d Approach
  • Classification of Pipeline Products
  • Cytotoxic Therapies
  • Molecular Targeted Therapies
  • Single-Target Signal Transduction Inhibitors
  • Angiogenesis Inhibitors
  • Apoptosis Inducers
  • Cell Cycle Inhibitors
  • Multi-Targeted Inhibitors
  • Epigenetic Modulators
  • Immunotherapeutic Agents
  • Evolution in Nsclc Clinical Trial Design
  • The Heterogeneity of Nsclc Makes Patient Selection A Critical Issue
  • Targeted Trial Designs Utilizing Biomarkers Are Increasingly Used
  • Early-Phase Clinical Trials and Endpoints May Need Redefining
  • Barriers May Still Exist to The Accrual of Patients to Nsclc Trials
  • Nsclc Trials May Not Be Very Representative of The Clinical Setting
• Chapter 5 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
  • Avastin (Bevacizumab Genentech/Roche/Chugai)
  • Erbitux (Cetuximab; Imclone/Merck Serono/Bristol-Myers Squibb)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Phase Iii Study of Erbitux with Cisplatin and Vinorelbine Meets Its Primary Endpoint of Improved Survival
  • Phase Iii Study of Erbitux with Carboplatin and A Taxane Fails to Meet Its Primary Endpoint
  • A Number of Other Trials Have Evaluated Erbitux in Nsclc
  • A Combination of Chemotherapy, Erbitux, and Avastin Is Being Evaluated
  • Erbitux May Enhance The Efficacy of Chemoradiotherapy in The Treatment of Unresectable, Locally Advanced Disease
  • Datamonitor Comments
  • Erbitux May Become The First Egfr Inhibitor to Show A Survival Improvement in Combination with Chemotherapy in The First-Line Setting
  • The Extent to Which US Physicians Will Adopt The Cisplatin/Vinorelbine Regimen May Affect Erbitux's Uptake
  • Erbitux May Achieve A Higher Uptake in Patients Who Are Not Eligible for Avastin Treatment
  • Erbitux Could Find Additional Application in The Treatment of Locally Advanced, Unresectable Nsclc
  • Forecasts to 2017
  • Nexavar (Sorafenib; Bayer Schering)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • The Combination of Nexavar with Platinum-Based Chemotherapy Fails to Improve Overall Survival in A Phase Iii Study
  • Nexavar Monotherapy Results in Disease Stabilization in The Second and Third-Line Settings
  • An Additional Study Has Evaluated Nexavar Monotherapy in The Second-Line Setting
  • Datamonitor Comments
  • Nexavar's Potential in Nsclc Now Significantly Limited
  • Nexavar Joins The Growing Number of Tkis That Have Failed in The First-Line Setting
  • Bayer Schering Has Adopted A 'Conservative' Strategy for Nexavar's Phase Iii Trial with Gemzar and Cisplatin
  • Forecasts to 2017
  • Recentin (Cediranib; Astrazeneca)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Two Phase I Trials Have Evaluated Recentin in The First-Line Treatment of Advanced Nsclc
  • Datamonitor Comments
  • Recentin Fails to Progress into Phase Iii in Advanced Nsclc
  • Sutent (Sunitinib; Pfizer)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Sutent Monotherapy Shows Moderate Clinical Activity in The Second- and Third-Line Setting of Advanced Nsclc
  • The Combination of Sutent with Gemzar and Cisplatin Is Safe and Tolerable
  • Datamonitor Comments
  • The Toxicity and Cost of Adding Sutent to Tarceva Will Need to Be Justified
  • Targeting The Second-Line Setting May Be A Successful Strategy for Sutent
  • Forecasts to 2017
  • Zactima (Vandetanib; Astrazeneca)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • The Addition of Zactima to Platinum-Based Chemotherapy Improves Progression-Free Survival in The First-Line Setting
  • The Combination of Zactima with Taxotere and with Iressa Improves Progression-Free Survival in The Second-Line Setting
  • Datamonitor Comments
  • Zactima's Multi-Targeted Nature Could Offer A Competitive Advantage
  • Zactima Is Targeting A Broad Population of Previously-Treated, Advanced Nsclc Patients
  • The Head-to-Head Trial against Tarceva Is A High-Risk Strategy
  • Astrazeneca's Strength in The Oncology Market Will Be Key to Zactima's Success
  • Forecasts to 2017
  • Zolinza (Vorinostat; Merck & Co)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Zolinza Shows Moderate Clinical Activity as A Second-Line Monotherapy in Nsclc
  • A Phase Ii Trial of Zolinza with Tarceva in Relapsed/Refractory Nsclc Was Terminated
  • Zolinza Shows Preliminary Evidence of Clinical Activity in Combination with Chemotherapy
  • Datamonitor Comments
  • A Different Strategy May Have Improved Zolinza's Chances of Success in The Nsclc Market
  • Forecasts to 2017
  • Aflibercept (Vegf-Trap; Sanofi Aventis/Regeneron)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Aflibercept Shows Manageable Toxicity and Some Evidence of Clinical Activity in Heavily Pre-Treated, Advanced Nsclc Patients
  • Datamonitor Comments
  • The Combination of Aflibercept with Taxotere Will Have to Demonstrate A Favorable Toxicity Profile
  • Aflibercept's Phase Iii Trial May Not Be Accounting for The Current Standards of Care
  • Aflibercept's Phase Ii Trial Results Are Interpreted Using The Modified Recist Criteria
  • Presence in Oncology Field Will Aid Commercialization of Aflibercept
  • Forecasts to 2017
  • Bibw 2992 (Boehringer Ingelheim)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Phase Iii Study Will Evaluate Bibw 2992 in Patients Who Have Failed Prior Therapy with Reversible Egfr Inhibitors
  • Bibw 2992 Shows Preliminary Evidence of Activity in A Phase I Study in Solid Malignancies
  • Datamonitor Comments
  • Targeting Patients Who Are Tarceva-Refractory May Be A Successful Entry Strategy into The Nsclc Market
  • Motesanib (Amg706; Amgen/Takeda Pharmaceutical)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • The Combination of Motesanib with Chemotherapy Is Safe and Shows Preliminary Evidence of Clinical Activity
  • Datamonitor Comments
  • Can Motesanib Succeed Where Other Tyrosine Kinase Inhibitors Have Failed?
  • Amgen Runs A High Risk with The Inclusion of Squamous Cell Patients in Motesanib's Phase Iii Trial
  • Forecasts to 2017
• Chapter 6 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)
  • Abraxane (Albumin-Bound Paclitaxel; Abraxis)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • The Combination of Abraxane with Carboplatin and Avastin Is Well-Tolerated
  • Abraxane Shows Clinical Activity and A Favorable Toxicity Profile as A First-Line Monotherapy in Metastatic Nsclc
  • Datamonitor Comments
  • A Novel Taxane with An Improved Toxicity Profile Could Gain A Share of The Nsclc Market
  • There Is A High Chance of Approval for Abraxane in Nsclc
  • Abraxane's Sales Growth in The Breast Cancer Market May Be Indicative of An Uptake in Nsclc
  • Forecasts to 2017
  • Glutoxim (Nov-002; Novelos)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Glutoxim Has Been Evaluated in The First-Line Treatment of Advanced Nsclc
  • Datamonitor Comments
  • Glutoxim's Clinical and Commercial Potential Cannot Be Evaluated
  • Forecasts to 2017
  • Javlor (Vinflunine; Pierre Fabre)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Javlor Shows Efficacy Equivalent to That of Taxotere in A Phase Iii Trial in Advanced Nsclc
  • Datamonitor Comments
  • Pierre Fabre's Intentions for Javlor in Nsclc Are Unclear
  • Javlor Will Face Intense Competition in The Second-Line Setting
  • Javlor Could Increase Its Uptake with Use in Combination with Radiotherapy
  • Forecasts to 2017
  • Lipoplatin (Liposomal Cisplatin; Regulon)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • The Combination of Lipoplatin with Gemzar Is Safe and Shows Evidence of Clinical Activity
  • Lipoplatin Shows A Better Toxicity Profile than Cisplatin as Part of A Combination Regimen with Paclitaxel
  • Datamonitor Comments
  • Favorable Market Conditions Exist for Novel Cytotoxic Agents Such as Lipoplatin
  • A More Experienced Oncology Player Could Improve Lipoplatin's Chances of Success in The Market
  • Forecasts to 2017
  • Taxoprexin (Dha Paclitaxel; Luitpold)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Taxoprexin Shows Moderate Clinical Efficacy and An Unfavorable Toxicity Profile in A Phase Ii Trial
  • Datamonitor Comments
  • Taxoprexin's Clinical Results to Date Raise Concerns regarding Its Future in The Nsclc Market
  • Forecasts to 2017
  • Xyotax (Paclitaxel Polyglumex; Cell Therapeutics/Novartis)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Three Phase Iii Trials Failed to Meet Their Primary Endpoints of Improved Overall Survival
  • Combined Analysis of Stellar 3 and Stellar 4 Showed A Survival Benefit in Women
  • Datamonitor Comments
  • Non-Inferiority May Grant Xyotax Approval in An Underserved Patient Population with Poor Prognosis
  • IT Is Unclear Whether Cell Therapeutics Will Achieve A Return on Xyotax's Development Costs
  • The Use of A Prognostic Biomarker for The Selection of Patients Could Enhance Xyotax's Clinical Results
  • Forecasts to 2017
• Chapter 7 Immunotherapies Analysis and Forecasts
  • Overview of Immunotherapies
  • Pipeline Summary
  • Late-Phase Pipeline of Immunotherapies
  • Phase Ii Pipeline of Immunotherapies
  • Phase I Pipeline of Immunotherapies
  • Comparative Forecasts
  • Definition of Current Comparator Therapy
  • Stimuvax (Blp-25; Merck Serono)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Stimuvax Shows Evidence of A Survival Benefit in Patients with Stage Iiib Locoregional Disease
  • Datamonitor Comments
  • The Need for A Minimally Toxic Maintenance Therapy May Drive Stimuvax's Uptake
  • Stimuvax May Have to Overcome Regulatory Hurdles
  • Forecasts to 2017
  • Mage-A3 Asci (Gsk1572932a; Glaxosmithkline)
  • Drug Overview
  • Key Historical Events
  • Clinical Development in Nsclc
  • Mage-A3 Asci Decreases The Risk of Cancer Recurrence after Surgery in A Phase Ii Trial
  • Datamonitor Comments
  • An Adjuvant Therapy with A Favorable Toxicity Profile Would Be Welcome in The Nsclc Market
  • Recruitment to The Large Phase Iii Trial May Present Challenges
  • Mage-A3 Needs to Overcome Regulatory and Pharmacoeconomic Obstacles
  • Forecasts to 2017
• Appendix
  • Bibliography
  • List of Tables
  • List of Figures
  • List of Abbreviations
  • Contributing Experts
  • Methodology
  • Datamonitor Forecast Methodology
  • Epidemiology Forecasts
  • Product Forecasts
  • Datamonitor Drug Assessment Summary
  • about Datamonitor
  • about Datamonitor Healthcare
  • Datamonitor Healthcare's Therapy Area Capabilities
  • about The Disease Analysis Team
  • Disclaimer