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Mol Diagn Ther. 2017 Jun;21(3):337-343. doi: 10.1007/s40291-017-0267-y.

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

Author information

1
Hospital Santa Crau y Sant Pau, Barcelona, Spain.
2
Translational Research Unit, CIBERONC, Albacete University Hospital, Albacete, Spain.
3
Clinical Research Support Unit, Albacete University Hospital, Albacete and Fundación Hospital Nacional de Paraplejicos, Toledo, Spain.
4
Department of Medical Oncology and Hematology, St. Claraspital, Basel, Switzerland.
5
Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
6
IBMCC-CSIC, Universidad de Salamanca, Salamanca, Spain.
7
Divisions of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
8
Translational Research Unit, CIBERONC, Albacete University Hospital, Albacete, Spain. albertoo@sescam.jccm.es.
9
Medical Oncology Department and Translational Research Unit, Albacete University Hospital, Edificio de Investigación, Calle Francisco Javier de Moya, 02006, Albacete, Spain. albertoo@sescam.jccm.es.
10
Regional Biomedical Research Center (CRIB), Castilla La Mancha University, Albacete, Spain. albertoo@sescam.jccm.es.

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
DOI:
10.1007/s40291-017-0267-y
[Indexed for MEDLINE]

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