Philip Beer, Chief Scientific Officer at Step Pharma and Chair of the BIVDA Genomics Working Group, gave an insightful overview of genomics in clinical practice in the UK. There are biomarker-associated treatments available for cancer patients. Still, we are unaware of the proportion of patients being screened to see whether the therapy is available to them or not. Studies in the US examining patient access to biomarkers show that it is suboptimal; however, this data is non-existent in the UK.
Beer stressed the urgency of addressing these data disparities. A few years ago, BIVDA gathered extensive information on genomic signatures, the clinical information associated with them, and the proportion of total information accounted for by the individual biomarkers. There were two key take-home messages from this study. Firstly, there are many biomarkers, and many genes must be examined to capture all the available information on cancer. Secondly, the amount of information ascribable to each biomarker is rather minimal, particularly in the case of highly mutated genes like TP53.
Beer highlighted the importance of clinical trials in biomarker testing: “Even phase one oncology trials can potentially produce responses and that they should really be considered as a potential therapy for the patients.” A phase I study in humans with a genomic biomarker has an average response rate of around 40%. This is a compelling reason to ensure that patients with cancer access broad genomic profiling and unlock the potential of phase I clinical trials.
The current situation in the UK shows that there is a strong vision for the use of genomics and a desire to deliver broad genomic profiling to all patients. Yet the reality is lagging behind; the UK has inadequate infrastructure and poor access to biomarker testing compared to its European counterparts. So, what are the barriers to biomarker testing in the UK?
Beer argued that the transactional relationship between academia, industry, and healthcare generates siloed thinking and low-efficiency models. Instead, we should focus on exchanging more knowledge between all sectors to refine and streamline the development process. This tactical approach can offer knowledge of what is needed in the clinic but also knowledge around access to clinical samples.
The genomic landscape in the UK is unique. For instance, England is broken down into seven genomic regions, but Scotland and Northern Ireland do not follow the same approach. Meanwhile, Wales follows a similar trajectory as England. Beer noted that the lack of unification between the four countries somewhat goes against the principles of the NHS. Furthermore, the UK has not incorporated IVDR into law, so the MHRA is in the process of drawing up UK-specific regulations. These factors create barriers to the adoption of genomic technology.
Beer suggested that clinical trials are the key to accelerating progress and efficiency between these three entities. The current model for recruiting for biomarker-associated trials is single analyte testing. This is a low-efficiency model because its iterative approach is time-consuming/inefficient. The alternative high-efficiency model comprehensively profiles all patients using a single assay early on in their treatment and finds eligible patients for treatment from the get-go. To do this, a collaborative strategy is needed to develop the correct assay which requires life cycle management and horizon scanning.
It is critical to articulate a value framework around genomics and address concerns held by sceptics who believe genomics is an unproven technology. Additionally, tackling uncertainty around commissioning is necessary to foster a genomic-focused path. Overall, Beer proposed that a self-learning healthcare system will cut through the confusion and help adapt treatments to patients.
