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Cancer Drug Discoveries: What the Future Holds: Non-Small Cell Lung Cancer Chapter
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Description: |
A comprehensive examination of the non-small cell lung cancer market and therapeutic approaches
Although a plethora of platinum-based chemotherapy combinations may be prescribed for the treatment of non-small cell lung cancer (NSCLC), the market is currently driven by chemotherapeutic agents such as the taxanes and antimetabolites, and the increasing use of targeted therapies. Some of the newer chemotherapy agents, such as Eli Lilly’s Gemzar and Alimta, have become the standard of care in combination with cisplatin or carboplatin and may be used in addition to or instead of the taxanes, Taxotere or Taxol/generic paclitaxel.
As researchers begin to understand the processes involved in NSCLC formation, several new targeted therapies have evolved that modulate growth factor pathways. Roche/Genentech's small-molecule tyrosine kinase inhibitor, Tarceva (erlotinib), and its anti-angiogenic VEGF inhibitor, Avastin (bevacizumab), are gaining credence in second- and first-line therapy, respectively.
Intense research is producing new approaches NSCLC is one of the most actively researched cancers, with approximately 110 drugs in the US being evaluated in clinical trials. The drugs span a variety of drug classes and whilst some represent new formulations of existing brands, others offer novel approaches to targeting angiogenesis or cell death. The much awaited cancer vaccines are now in Phase III, with first launch expected in 2012.
By 2014, it is expected that at least five new chemotherapeutic agents will be launched to be used in combination with existing treatment protocols and, in some cases, may replace older products, including: Abraxis BioSciences' Abraxane and Cell Therapeutics/Novartis' Opaxio, both new formulations of paclitaxel; the third-generation platinum-based therapies, sanofi-aventis’ Eloxatin and GPC Biotech's satraplatin; and Bristol-Myers Squibb's epothilone analogue, Ixempra.
The addressable NSCLC market will increase by 9.8% by 2014. What are the current and new products that will drive commercial growth and what are the therapeutic approaches to watch?
Lung cancer affects over 1.4 million patients. Non-small cell lung cancer, which accounts for approximately 87% of all lung cancers, is one of the leading causes of death, killing more patients than breast, colon and prostate cancer together and accounting for nearly 30% of all cancer deaths. Survival rates are among the worst for any cancer with a large and growing unmet clinical need.
A changing approach The NSCLC market is set for radical change. A number of current first-line therapies will become subject to generic competition in the short term and, although chemotherapy will continue to play a significant if diminishing role, industry attention is firmly on the better tolerated biologics, which are already setting the pace in the market and whose influence will grow over the coming years. In 2007, chemotherapy treatments accounted for 68% of the market, but are forecast to account for only 36% by 2014. Targeted treatments are forecast to increase from 32% to 60% over the same period.
Impact on the industry Roche/Genentech – currently the dominant player in the sector – will move into an even more commanding position, accounting for 42% of the market through the ongoing sales and development of leading products such as Avastin and Tarceva. The market will be more diverse, with 12 companies taking more than 1% market share in 2014, as opposed to 6 in 2007.
Vaccines The benefits of lung cancer vaccines remain significant, but without launch and experience of large patient populations in post-launch, they remain just a promise. Of the candidates in Phase III, Merck’s Stimuvax is expected to be first to market in 2012, with GSK’s MAGE-A3/GSK1572932A following on.
On the horizon: new Phase II approaches show promise Targeting TRAIL (TNF-related apoptosis-inducing ligand) receptors is one avenue that is currently being explored by a number of companies. TRAIL induces apoptosis via two death domain-containing receptors, TRAIL-R1 (DR4) and TRAIL-R2 (DR5). Human Genome Sciences' mapatumumab is the most advanced death receptor activator currently under development, while other candidates with potential include: Amgen's AMG 655, Amgen/Genentech's AMG 951 and Genentech's apomab.
This unbeatable executive report provides…
- A comprehensive review of the market, disease incidence and growth - An evaluation of the current understanding of non-small cell lung cancer - A comparison of the corporate and competitive landscape in 2007 and 2014 - Detailed analysis and 5-year sales forecasts for current products by value - A detailed review of up and coming products with 5-year forecasts from year of launch - Unique product assessment and scoring
CURRENT PRODUCTS EVALUATED & FORECAST - Taxol (BMS) - Taxotere (sanofi-aventis) - Alimta (Eli Lilly) - Gemzar (Eli Lilly) - Iressa (AstraZeneca) - Tarceva (Roche/Genentech/OSI) - Avastin (Roche/Genentech/Chugai)
LATE-PHASE PRODUCTS EVALUATED AND FORECAST - Abraxane (Abraxis) - Opaxio (Novartis) - Erbitux (Eli Lilly/BMS) - Figitumumab (Pfizer) - Aflibercept (sanofi-aventis/Regeneron) - Nexavar (Bayer/Onyx) - Sutent (Pfizer) - Tovok (Boehringer Ingelheim) - Vargatef (Boehringer Ingelheim) - Zactima (AstraZeneca) - ASA404 (Novartis)
Vaccines - Lucanix (NovaRx) - MAGE-A3 (GSK) - Stimuvax (Merck KGaA)
NOVEL PHASE II PRODUCTS EVALUATED INCLUDE
Angiogenesis Inhibitors - Recentin (AstraZeneca) - Armala (GSK) - ABT-869 (Abbott/Genentech) - Axitinib (Pfizer) - IMC-1121B (Eli Lilly)
Death Receptor Agonists - AMG 655 (Amgen/Genentech) - AMG 951 (Amgen/Genentech) - Apomab (Genentech) - Mapatumumab (Human Genome Sciences) |
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Contents: |
EXECUTIVE SUMMARY The Facts
WHAT IS NSCLC AND HOW DOES IT AFFECT PATIENTS? PATIENT STATISTICS Incidence, Diagnosis Rates and Treatment; Now and in the Future The US Europe Japan Patient Mode The Addressable NSCLC Market Will Increase by 9.8 per cent by 2014
DRUG GROWTH DRIVERS DRUG GROWTH RISKS/DAMPENERS THE NSCLC MARKET GLOBAL NSCLC SALES SPLIT US Market European Market Japanese Market
THE PLAYERS Players and Products in 2007 Players and Products in 2014 Curent Treatments
SURGERY RADIATION
CHEMOTHERAPY Leading Brands Chemotherapy Regimens Current Products' Patent Exposure Novel Targeted Therapies Targeting EGFr Targeting VEGF Current Products' Patent Exposure
ANALYSIS OF LEADING BRANDS CHEMOTHERAPY Taxanes Taxol Taxotere Antimetabolites Alimta Gemzar
NOVEL TARGETED THERAPIES EGFr Inhibitors Iressa Tarceva VEGF Inhibitor Avastin Sales Forecasts Of Curent Nsc lc Drugs
RESEARCH & DEVELO PMENT OF NSCLC DRUGS ANALYSIS OF LATE-PHASE DRUGS CHEMOTHERAPY Taxanes Abraxane Opaxio
TARGETED THERAPY EGFr Inhibitors Erbitux IGF-1r Inhibitors Figitumumab Multi-action Inhibitors Aflibercept Nexavar Sutent Tovok Vargatef Zactima Tumour Vascular Disrupting Agents ASA404
VACCINES Lucanix MAGE-A3 Stimuvax Other Phase III Drugs AMG 706 NOV-002 Telcyta
GLOBAL SALES FORECASTS OF LATE-PHASE NSCLC DRUGS Model Assumptions
ANALYSIS OF PHASE II DRUGS Chemotherapy Eloxatin Ixempra Satraplatin Angiogenesis Inhibitors Recentin Armala ABT-869 Axitinib IMC-1121B Death Receptor Agonists AMG 655 AMG 951 Apomab Mapatumumab Other Classes Bavituximab Enzastaurin OGX-011 Perifosine PF-3512676 Velcade Vaccines IDM-2101 TG 4010 Competitor Rati o Analysis Competitor Ratio Analysis Criteria
COMPETITOR RATIO ANALYSIS - PRODUCTS COMPETITOR RATIO ANALYSIS - COMPANIES
WINNERS & LOSERS Winners Losers
DISCONTINUATION OF NSCLC DRUGS
APPENDIX 1: PATIENT MODEL APPENDIX 2: GLO BAL NSCLC DRUGS SALES APPENDIX 3: PHASE TRANSITION PROBABILITY
BIBLIOGRAPHY GLOSSARY Acronymns
Index of Tables Stages of NSCLC and Survival Rates Male and Female Lung Cancer Incidence Rates (Top Five Countries) Summary of Global NSCLC Patient Population Forecasts in Top Seven Countries (2007E-2014E) Standard NSCLC Therapy Platinum-Based Regimens FDA-Approved Regimens for Advanced NSCLC Doublet Regimens EGFr Expression in Solid Tumours Patent Exposure of Leading Brands Efficacy of Taxotere in the Treatment of NSCLC Patients Previously Treated with a Platinum-Based Chemotherapy Regimen (Intent-to-Treat Analysis) Proposed NSCLC Filings for Avastin Avastin Development Proposed Filings of New Indications for Avastin Global NSCLC Sales of Leading Brands 2007A-2014E (US$ millions) Products In Clinical Development for the Treatment Of NSCLC New Drugs in Late-Phase Development to Treat NSCLC Sales Forecasts of Late-Phase Developmental NSCLC Drugs (US$ million) New Drugs in Phase II Development to Treat NSCLC Axitinib Treatment-Related Adverse Events Key NSCLC Drugs Analysed Summary of Key Companies and Drugs in the NSCLC Market by 2014 NSCLC Drugs Discontinued During Development Summary of US NSCLC Patient Population Forecasts Summary of Europe (Top Five) NSCLC Patient Population Forecasts Summary of Japan NSCLC Patient Population Forecasts Global NSCLC Drugs Sales 2007A-2014E Probability of Launch
Index of Charts Schematic of the Lung New Cancer Deaths Estimates (2008)* Tobacco use in the US 1900-2002 Global NSCLC Market by Therapy Class (2007A) Global NSCLC Market by Therapy Class (2014E) Global NSCLC Market by Region (2007A) US NSCLC Major Drugs Sales Split (2007A) European NSCLC Major Drugs Sales Split (2007A) Market Share of NSCLC Players by Sales (2007A) Market Share of NSCLC Players by Sales (2014E) EGFr Signal Transduction in Tumour Cells Angiogenesis is the Formation of New Blood Vessels Agents Targeting the VEGF Pathway Efficacy Parameters in Phase III Trials Taxol NSCLC Sales (2007E-2014E) TAX317 Survival K_M Curves - Taxotere 75mg/m2 vs. Best Supportive Care TAX320 Survival K_M Curves - Taxotere 75mg/m2 vs. Vinorelbine or Ifosfamide Control. Taxotere-Treated Patients as % of Patient Popluation (Top 7) Taxotere NSCLC Sales (2007E-2014E) Alimta NSCLC Sales (2007A-2014E) Gemzar NSCLC Sales (2007E-2014E) Iressa NSCLC Sales (2007A-2014E) Tarceva NSCLC Sales (2007E-2014E) Avastin NSCLC Sales (2007E-2014E) 2008 Survey: Medicines in Development for Cancer Abraxane NSCLC Sales (2011E-2014E) Opaxio NSCLC Sales (2009E-2014E) Erbitux NSCLC Sales (2009E-2014E) Pfizer's NSCLC Clinical Development Programme CP-751,871 NSCLC Sales (2013E-2014E) Aflibercept NSCLC Sales (2012E-2014E) Nexavar NSCLC Sales (2012E-2014E) Sutent NSCLC Phase II Results and Phase III (SUN 1087) Study Design Pfizer's NSCLC Clinical Development Programme Sutent NSCLC Sales (2012E-2014E) Tovok NSCLC Sales (2013E-2014E) Vargatef NSCLC Sales (2013E-2014E) Zactima’s Triple Mechanism of Action Zactima NSCLC Sales (2010E-2014E) ASA404 NSCLC Sales (2012E-2014E) Stimuvax NSCLC Sales (2012E-2014E) Ixabepilone: Preclinical Synergy With Targeted Therapies AZD2171 Mechanism Of Action Efficacy and Pharmacokinetic Profile of AZD2171 Compared to Avastin AZD2171 Dose-Dependent Efficacy in NSCLC Axitinib in First-Line NSCLC Mechanism of Action of HGS-ETR1 PF-3512676 Mechanism of Action Through TLR modulation |
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