Impact of Availability of Companion Diagnostics on the Clinical Development of Anticancer Drugs.

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Impact of Availability of Companion Diagnostics on the Clinical Development of Anticancer Drugs.

Mol Diagn Ther. 2017 Feb 28;:

Authors: Tibau A, Díez-González L, Navarro B, Galán-Moya EM, Templeton AJ, Seruga B, Pandiella A, Amir E, Ocana A

Abstract
BACKGROUND: Companion diagnostics permit the selection of patients likely to respond to targeted anticancer drugs; however, it is unclear if the drug development process differs between drugs developed with or without companion diagnostics. Identification of differences in study design could help future clinical development.
PATIENTS AND METHODS: Anticancer drugs approved for use in solid tumors between 28 September 2000 and 4 January 2014 were identified using a search of the US FDA website. Phase III trials supporting registration were extracted from the drug label. Each published study was reviewed to obtain information about the phase I and II trials used for the development of the respective drug.
RESULTS: We identified 35 drugs and 59 phase III randomized trials supporting regulatory approval. Fifty-three phase I trials and 47 phase II trials were cited in the studies and were used to support the design of these phase III trials. The approval of drugs using a companion diagnostic has increased over time (p for trend 0.01). Expansion cohorts were more frequently observed with drugs developed with a companion diagnostic (62 vs. 20%; p = 0.005). No differences between drugs developed with or without a companion diagnostic were observed for the design of phase I and II studies.
CONCLUSIONS: The approval of drugs developed with a companion diagnostic has increased over time. The availability of a companion diagnostic was associated with more frequent use of phase I expansion cohorts comprising patients selected by the companion diagnostic.

PMID: 28247182 [PubMed - as supplied by publisher]

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