R&D Trends: Prostate Cancer - Newly approved therapies shift treatment dynamics for castrate-resistant disease

Introduction

The late-phase prostate cancer pipeline is dominated by targeted therapies, closely followed by immunotherapies. There are a growing number of therapies with novel targets such as Zibotentan (AstraZeneca) which targets endothelin-A (ET-A). Identification of the correct molecular target will be key to ensuring that a novel drug is effective.

Features and benefits

* In-depth analysis of the prostate cancer pipeline – development stage, therapeutic class, molecular targets, and changes in pipeline since 2009
* In-depth analysis of current comparator therapy – target product profile, unmet needs, and innovative early-stage approaches
* In-depth analysis of clinical trial design – patient selection, duration, clinical endpoints, and future developments in trial design
* The future of prostate cancer treatment – improving biomarkers, and novel targeted therapies

Highlights

Targeted therapies dominate the prostate cancer pipeline. However, developers will face strong competition from recently approved therapies. The advancement in understanding the molecular basis of prostate cancer has exposed new targets, but companies must identify the correct ones to improve the chances of success.
Clinical trial design must demonstrate the clinical efficacy of novel therapies. The selection of correct patient populations, trial duration, and endpoints is becoming increasingly important in the era of target therapy development.
New therapies will have to focus on improving overall survival in advanced, castrate-resistant disease, particularly when other therapies have been exhausted. They must be superior to the current standard of care, Taxotere (docetaxel; Sanofi).

Your key questions answered

* Understand how the dynamics of prostate cancer treatment are changing as a result of newly emerging therapies
* Identify the target product profile for new therapies and innovative early-stage drug targets in relation to the current standard of care
* Assess the potential for new innovative approaches to treating prostate cancer and obstacles that may affect their development
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Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Pipeline summary
Molecular targeted therapies represent over half of the prostate cancer development pipeline
Newly approved Zytiga changes the late-phase pipeline dynamics
Targeted therapies remain the most dominant drug class in the pipeline
The majority of drugs are in Phase II development
Late-stage development compounds recently discontinued
Avastin (bevacizumab; Genentech/Roche/Chugai)
TARGET PRODUCT PROFILE
Taxotere (docetaxel; Sanofi)
Taxotere’s main mode of action is microtubule disruption
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN PROSTATE CANCER
Typical trial design
Criteria to assess clinical response
[Missing title]
Trial endpoints
Most oncology clinical trials designate multiple endpoints
Overall survival versus progression-free survival
Response rate
PSA levels
Quality of life
Toxicity
Bone metastasis
Future developments in clinical trial design
Trial designs must reflect the nature of the drug being tested
INNOVATIVE EARLY-STAGE APPROACHES
Abrogation of androgen receptor signaling
HSP90 is needed for AR stabilization
HDACs
Epigenetic modulation
MAGE-11
DNA vaccines
Molecular targeting maintains the most promise as an early-stage approach
THE FUTURE OF TREATMENT IN PROSTATE CANCER
Improved chemoprevention will relieve disease impact
Low uptake of pharmacological agents represents need for safer chemoprevention
Identification of modifiable risk factors will encourage the emergence of new therapies
Sub-group analyses may influence treatment choices
Patient stratification could influence response to treatment
Genomic sequencing spurs the development of pathway inhibitors
Newly approved treatments must be appropriately sequenced
Zytiga approval is set to influence the order of drug use in late-stage disease
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Report methodology
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