2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

This situation is not surprising, given that most advanced
human malignancies have complex signaling networks. Nevertheless,
the one-size-fits-all approach for drug development
of MTAs in solid tumors has shown disappointing
results in recent years. It is no longer viable to develop
targeted drugs without a reliable indicator of a potential
benefit derived from them. The genomic-driven accelerated
approach of drug development is applicable when the appropriate
patient population can be evaluated in the phase I
trial. This conceptual shift of clinical development of pairing
therapies and biomarkers will require a change in the design
and execution of clinical trials to one where antitumor
Authors’ Disclosures of Potential Conflicts of Interest
Employment or
Leadership
Positions
Consultant or
Advisory Role
Author
Rodrigo Dienstmann*
Jordi Rodon*
Josep Tabernero Amgen; Bristol-
Myers Squibb;
Genentech;
Merck KGaA;
Novartis; Onyx;
Pfizer; Roche;
Sanofi
*No relevant relationships to disclose.
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activity of MTAs is evaluated. Hopefully, the decreasing cost
of high-throughput molecular technologies will enable more
comprehensive characterization of the numerous additional
tumor genome alterations, and, therefore, facilitate a personalized
oncology approach. 29 In addition, alternative techniques
to biopsy of the metastatic disease might be
considered in the near future, such as molecular imaging
and genomic analysis of circulating tumor cells, or tumor
DNA detected in peripheral blood. 30 In conclusion, biologic
evidence, clinical data, and previous experience propose that
it is time for a change in the current way drug development
of targeted agents is done.
Stock
Ownership Honoraria
REFERENCES
Amgen; Merck
KGaA; Novartis;
Roche; Sanofi
DIENSTMANN, RODON, AND TABERNERO
Research
Funding
Expert
Testimony
Other
Remuneration
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