R&D Trends: Non-Small Cell Lung Cancer - Mutation Analyses Continue Driving Treatment Choices
Datamonitor, April 2012, Pages: 38
Review of key R&D trends in non-small cell lung cancer (NSCLC) including; dynamics of the pipeline, comparator therapies, target product profile, trends in clinical trial design, innovative early-stage projects, and the future of NSCLC treatment.
The 220 drugs in the non-small cell lung cancer (NSCLC) pipeline, is dominated by targeted therapies across all stages. There are a growing number of immunotherapies in development as drug developers look to target mutations and tumor specific antigens.
Scope
- Analysis of the non-small cell lung cancer pipeline - development stage, therapeutic class, molecular targets, and changes in the last two years.
- In-depth analysis of current comparator therapy - target product profile, unmet needs, and innovative early-stage approaches.
- Detailed discussion of clinical trial design - patient selection, duration, clinical endpoints, and future developments in trial design.
- Exploration of the future of non-small cell lung cancer treatment - increasing use of biomarkers, immunotherapies, and predictive biomarkers.
Highlights
- Targeted therapies dominate the non-small cell lung cancer (NSCLC) pipeline across all stages. However, interest in immunotherapies is growing with 7 vaccines currently in Phase III development. Advances in the understanding of the heterogeneity of NSCLC have led to launch of new, novel targeted therapies.
- The selection of correct patient populations, trial duration, and endpoints is becoming increasingly important in the era of personalized therapy development. The use of companion diagnostics in non-small cell lung cancer (NSCLC) is somewhat modest, but is likely to grow in the future.
- Future non-small cell lung cancer (NSCLC) treatment will rely on new combination regimens, multiple pathway inhibitors, and the introduction of new immunotherapies. New drugs will have to improve overall survival in advanced, metastatic disease while limiting toxicity to compete with the current standard of care - Avastin plus chemotherapy.
Reasons to Purchase
- Identify key trends in the non-small cell lung cancer (NSCLC) pipeline, including development stage, molecular targets, and therapeutic class
- Assess how pipeline drugs will fit into the treatment paradigm for NSCLC analyzing any key competitors they will face when launched
- Assess key decisions in NSCLC clinical trial design regarding patient selection, trial duration, endpoints, and predictive biomarkers
OVERVIEW
- Catalyst
- Summary
EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor key findings
- Related reports
CLINICAL PIPELINE OVERVIEW
- Datamonitor has identified 209 drugs in development for non-small cell lung cancer
- The global burden of NSCLC is an incentive for drug developers
- Targeted therapies dominate the late-stage pipeline
- Targeted therapies dominate the NSCLC pipeline across all stages
- The NSCLC pipeline has grown by 56% over the last 2 years
- Late-stage development compounds recently discontinued?Motesanib (Amgen/Takeda)
- - Vadimezan (Antisoma)
- - Iniparib (BSI 201; Sanofi)
TARGET PRODUCT PROFILE
- Avastin (bevacizumab; Genentech/Roche/Chugai)
- - Clinical trial data for Avastin
- Target product profile versus current level of attainment
- - Unmet needs in non-small cell lung cancer
- - Avastin’s ability to fulfill unmet needs in NSCLC
CLINICAL TRIAL DESIGN IN NON-SMALL CELL LUNG CANCER
- Clinical trial design
- Patient selection?Companion diagnostics integral to success of targeted therapy
- - Clinical endpoints
- Future developments in clinical trial design
- - Mutation-specific therapy
- - Targeting primary and secondary resistance
- - Distinguishing between oncogenic drivers and non-significant mutations
INNOVATIVE EARLY-STAGE APPROACHES
- Treatment inhalation via nebulizer
- Volatile compounds as predictive biomarkers
- Drug combinations to target multiple pathways
- Targeted drugs as maintenance therapy
THE FUTURE OF TREATMENT IN NON-SMALL CELL LUNG CANCER
- Molecular profiling will continue through companion diagnostic development
- Avastin as maintenance
- Immunotherapy: numerous vaccines on the horizon?Protein-based vaccines (MAGE-A3)
- - Peptide-based vaccines (MUC1)
- - Gene-based vaccines: Lucanix (belagenpumatucel-L; NovaRx Corporation)
BIBLIOGRAPHY
- Journal papers
- Websites
- Datamonitor reports
- Other
APPENDIX
- Contributing experts
- Conferences attended
- Report methodology
TABLES
- Table: Phase III pipeline products in development for non-small cell lung cancer, 2012
- Table: Recently discontinued other drugs in non-small cell lung cancer, 2012
- Table: Avastin (bevacizumab; Genentech/Roche/Chugai) drug profile, 2012
- Table: Ability of Avastin (bevacizumab; Genentech/Roche/Chugai) to meet unmet needs in NSCLC, 2012
- Table: Phase III trial design for Xalkori (crizotinib; Pfizer)
- Table: Iressa (gefitinib; AstraZeneca) key historical events, 1994-2010
- Table: Investigative biomarkers and their clinical significance in NSCLC
FIGURES
- Figure: NSCLC pipeline, by development phase, 2012
- Figure: Pipeline NSCLC therapies by therapeutic class and phase, 2012
- Figure: NSCLC pipeline, by class, 2010 and 2012
- Figure: Phase III pivotal trial of Avastin (bevacizumab; Genentech/Roche/Chugai) versus paclitaxel plus carboplatin for advanced non-squamous non-small cell lung cancer
- Figure: Distribution of most common primary and secondary endpoints in the late-phase NSCLC pipeline
- Merck KGaA
- Schindler Holding Ltd.
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