Introduction: selecting rational combinations for cancer and delivering early phase clinical trials in the UK

Abstract

Combination strategies must be investigated earlier in the drug development pipeline to maximise opportunities. This session will provide an overview of current models and collaborative ways of working to support investigator led combination clinical trials, involving UK academia, biotech and pharma. The Experimental Cancer Medicine Centres (ECMC) Combinations Alliance (http://www.ecmcnetwork.org.uk/ca) will be presented along with novel preclinical and clinical data describing lessons learnt from the different collaborative experiences. A focus will also be given to radiotherapy-drug consortium (RaDCom) and indications not typically followed by industry. The ECMC Combinations Alliance has grown considerably over the last 12 months and new initiatives are currently being considered. Even with their significant resources, drug companies can only explore a fraction of all possible treatment combinations. So frameworks for different combination strategies allows investigation of safety and preliminary efficacy, whilst encompassing novel biomarkers to ensure combination therapies are tailored to the patient’s disease. Successful delivery is essential in todays’ competitive environment and Combinations Team in CRUK Centre for Drug Development adds robust process and efficiencies to drive these studies forwards. In addition, the ECMC Combinations Alliance Joint Steering Committee shapes future strategy, triages the broad range of ideas submitted and identifies proposals that require additional preclinical rationale. There is huge opportunity to maximize the effective use of targeted therapies in combination with other targeted therapies or conventional agents such as chemotherapy or radiotherapy. The introduction will cover important questions that need to be answered in order for these strategies to succeed clinically, with examples from drugs targeting the PI3 kinase pathway.

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