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Nat Rev Cancer. 2016 Apr 26;16(5):319-29. doi: 10.1038/nrc.2016.35.

Defining actionable mutations for oncology therapeutic development.

Author information

1
Oncology IMED, AstraZeneca, Darwin Building, Cambridge Science Park, Cambridge CB4 0WG, UK.
2
Oncology IMED, AstraZeneca, Waltham, Massachusetts 02451, USA.
3
Oncology IMED, AstraZeneca, Alderley Park, Macclesfield SK10 4TG, UK.

Abstract

Genomic profiling of tumours in patients in clinical trials enables rapid testing of multiple hypotheses to confirm which genomic events determine likely responder groups for targeted agents. A key challenge of this new capability is defining which specific genomic events should be classified as 'actionable' (that is, potentially responsive to a targeted therapy), especially when looking for early indications of patient subgroups likely to be responsive to new drugs. This Opinion article discusses some of the different approaches being taken in early clinical development to define actionable mutations, and describes our strategy to address this challenge in early-stage exploratory clinical trials.

PMID:
27112209
DOI:
10.1038/nrc.2016.35
[Indexed for MEDLINE]

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