Societal Challenges of Precision Medicine – Patients’ assumptions versus clinical practice

A recently published article in the European Journal of Cancer discusses the practical requirements and challenges of developing new precision medicine strategies, based on leveraging complex genomic profiles, as discussed at the Innovation and Biomarkers in Cancer Drug Development (IBCD) meeting (8–9 September 2016, Brussels, Belgium) organised jointly by representatives from the European Organisation for Research and Treatment of Cancer (EORTC), the US National Cancer Institute (NCI), the European Medicines Agency (EMA), and the American Association for Cancer Research (AACR).

Among cancer patients, the term “precision medicine” or “personalised medicine” is generally understood to refer to a medical model which uses the characterisation of individuals’ phenotypes and genotypes for tailoring the right therapeutic strategy for the right person at the right time, to determine the predisposition to disease and to deliver timely targeted prevention.

In order for such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework is required.

Denis Lacombe, Director General of EORTC explains: “It cannot be ignored that there still is a widespread belief that the roll-out of cancer precision medicine largely constitutes a trend that has received a lot of hype, but one that actually won’t lead to widespread changes in clinical practice.”

Roberto Salgado, Co-chair of the IBCD 2018, emphasized “the IBCD conference was critical in bringing forward the quality assurance dimension from pre-analytical steps to implementation into health care systems for precision oncology”.

However, the answer to the question if precision medicine can now be delivered in a sustainable and affordable manner is “Yes, it can”, in so far as certain molecular biomarkers may be used to select patients for particular targeted therapies with clear patient benefits, improving the cost effectiveness of a specific treatment while sparing other patients from unnecessary toxicity.

The focus of the IBCD meeting, which involved stakeholders from industry, regulatory agencies, academia and government, was to explore the practical issues relating to how biomarker assay development could be more effectively integrated into drug development and regulatory approval processes to drive further progress in cancer-related precision medicine, all this benefiting society within a healthcare context. This is of particular importance given the emergence of commercial entities offering for-profit tumour DNA sequencing services directly to cancer patients or through the hospital-setting, which may in turn create a patient demand for non-evidence-based, off-label, targeted therapies. Taking this into consideration, a series of critical points and consensus recommendations relating to the development of precision medicine approaches were agreed at this IBCD meeting.

IBCD 2018, will take place on 29 – 30 November 2018 at the Radisson Blu Royal Hotel Brussels, Brussels, Belgium. More information will be available soon.