Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?
Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.
Carden
Craig P
CP
Drug Development Unit, Royal Marsden Hospital, Marsden Hospital, Sutton, Surrey SM2 5PT, UK.
Sarker
Debashis
D
Postel-Vinay
Sophie
S
Yap
Timothy A
TA
Attard
Gerthardt
G
Banerji
Udai
U
Garrett
Michelle D
MD
Thomas
George V
GV
Workman
Paul
P
Kaye
Stan B
SB
de Bono
Johann S
JS
D000970:Antineoplastic Agents / Q000627:therapeutic use; D054316:Biomarkers, Pharmacological / Q000032:analysis*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D017277:Drug Approval; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D008954:Models, Biological; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D010597:Pharmacogenetics
D000970:Antineoplastic Agents; D054316:Biomarkers, Pharmacological