Time to get stratified

As genetic screening becomes routine for cancer detection and treatment, we need to ensure this can be delivered at scale and quickly within a national health system. Here, Don White takes us through this challenge and looks at the success of CRUK’s Stratified Medicine Programme 2…

It’s clear genomics will be at the heart of future healthcare provision. That is especially true of cancer care – indeed, the use of genomic screening to guide the treatment of cancer patients is becoming routine. But there are challenges remaining to make this a reality, and implementation of this approach within complex healthcare systems is certainly one of them.

“SMP2 arguably delivered the first truly universally accessible clinical trial for cancer.”

Enter CRUK’s Stratified Medicine Programme 2 (SMP2), one of the largest studies of its kind anywhere in the world. SMP2 arrived in 2015 as the natural extension of SMP1, a national genomic screening programme to screen for cancer-associated gene mutations across 6 common cancer types. While SMP1 remained a purely observational study – collecting data on the mutational landscape of melanoma, lung, colon, breast, ovarian and prostate cancers – SMP2 focused exclusively on identifying patients eligible for the National Lung Matrix Trial (NLMT). This is a precision medicine trial specifically for non-small cell lung cancer (NSCLC), sponsored and administered by the University of Birmingham CRUK clinical trials unit.

Large undertaking

SMP2 was not a trivial initiative. The programme incorporated a network of over 50 NHS trust hospitals, where NSCLC patients were recruited for entry into the study.

Biopsy material collected from these patients was sent to one of three NHS labs for identification of NSCLC-related genomic mutations, providing cohorts of patients who were eligible for the NLMT. NHS hospitals and labs were chosen to demonstrate how a national stratified genomic medicine service could indeed be embedded within the NHS.

“What SMP2 delivered on so successfully was shaping the future of genomic testing for every cancer patient across the UK.”

All of this required collaboration with a network of labs and hospitals in a hub-and-spoke arrangement, involving a core of 22 clinical hubs who received patients from a local hospital network within a geographical catchment area. In this way, SMP2 arguably delivered the first truly universally accessible clinical trial for cancer, in line with the objectives of the NHS.

Testing of the genomic landscape of patients was performed using various versions of gene-testing platforms or panels. The pioneering aspect of SMP2 required a close working collaboration with our commercial partners, particularly illumina and their UK team based in Cambridge. The SMP2 team worked with NHS labs and illumina over the entire duration of the programme to not only improve and upgrade the genomic testing technology, but also to introduce change to the NHS labs which can be incorporated into future work beyond SMP2.

SMP2 was indeed a success story of how academic, charitable and commercial interests can work together to deliver real change within a health care system to the benefit of patients. Something David McBride, Senior Manager at illumina also recognises. “The programme has spanned an incredibly exciting time in sample testing, where multiple complex lab techniques querying single genes have been streamlined into a single assay and analysis workflow through the application of next generation sequencing,” he says. “We feel sure that the improvements in genomic testing made through SMP2 will allow many more patients to receive precision cancer care in the UK.”

Looking to impact

Research leads to discovery, and translational initiatives bring those discoveries closer to the clinic. But along the way we need infrastructure and operations to be able to provide novel treatments on a national level. This, in fact, was what SMP2 delivered on so successfully, shaping the future of genomic testing for every cancer patient across the UK.

Over the 7 years, from its opening until its closure in 2021, more than 7000 patient biopsy samples arrived at an SMP2 NHS lab for analysis, from over 10,000 NSCLC patients consented to the programme. Of those, over 400 patients were eventually enrolled onto the NLMT. That really is a commendable achievement, given both the complex molecular criteria for eligibility, as well as the nature of the disease in terms of rapid changes in patient health status.

And it is of particular note that patients see the potential of this effort too. “So many have benefitted from SMP2’s trial and approach over the years. Learning which treatments won’t work has been just as important as those that will,” explains Janette Rawlinson, Patient Representative for SMP2.

When cancer patients in the UK are routinely offered genetic testing to select the most appropriate treatment for their disease, they will in large part have SMP2 to thank. There is of course much more work to be done, but thanks to the SMP2 team, commercial partners, labs, patients and clinical network, the future of precision medicine within the NHS is being realised.

Read more about how the findings of the SMP2 trial can be applied

Author:
Dr Don White is Portfolio Lead, Scientific Operations at Cancer Research UK. He was Programme Manager of the SMP2 study.

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