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Progress has been made
• People living longer with cancer
• Five year survival overall is 67%
• Better understanding of the science of
cancer has led to better diagnosis and
treatment
New ways of thinking about cancer
Old
by site and type of tissue ie
adenocarcinoma of the lung
New
by cellular abnormality ie EGRF mutation
Understanding pathways and interactions
• Leading to targeted therapies
• Companion diagnostics
• Better understanding of resistance
mechanisms
• Combination approaches
New understanding of factors external to tumor
• Tumor vasculature and stromal cells
• Immune tolerance
Able to target specific abnormalities
• More individualized approach
• Companion diagnostics to screen patients
likely to respond
• Better understanding of resistance
mechanisms
Many drugs in trials
• More than a thousand cancer trials
• 47 new cancer drugs approved in last 10
years
Many trials /drugs fail
• 5% of drugs that enter trials are approved
• 60% of successful Phase II drugs fail in
Phase III
Health economics
• Need for differentiation/advantage
• Puts pressure on companies to do larger
more expensive trials
Significant problem for oncology drugs
Traditionally poor prediction from
animal models
some improvement with
knockout models and patient derived
samples
Trials long and expensive
Pressure for early less expensive answers
• Biomarkers
• Clever trial design
• Patient enrichment
• Need for “Phase III results from Phase I trial”