All patients’ cancers should be genetically profiled to improve care, say leading health experts

• Consensus group calls for routine use of ‘biomarker’ tests and molecular profiling of cancers to guide use of precision medicines 
• NHS should increasingly use panel tests to assess multiple biomarkers at once – and match patients to the best treatment for them
• Regulatory reform needed so modern cancer treatments can routinely be developed and approved with companion biomarker tests

The NHS should offer all cancer patients genetic profiling of their cancers at diagnosis and during treatment to shape care and track how the disease evolves, a consensus group of leading experts has concluded.

Group members said action was needed to ensure use of cancer treatments was routinely guided by information about a patient’s individual cancer.

They called for barriers preventing patients from gaining access to ‘biomarker’ tests to be removed – so genetic information and other tests could routinely be used to select the most suitable precision medicine for each patient.

The consensus group was convened by The Institute of Cancer Research, London, and included nine leading institutions, charities, stakeholder groups and life-science companies, including Cancer Research UK and the Association of the British Pharmaceutical Industry.

Biomarker tests look for genetic, protein or imaging ‘markers’ to identify which patients are most likely to respond to treatment.

It is crucial for clinicians to be able to assess biomarkers so they can select patients with particular weaknesses in their cancers and match treatment accordingly. But the consensus group warned that testing is not always done because regulatory processes and resources have not kept pace with the science.

The Institute of Cancer Research (ICR) is releasing new consensus statements today. The other members in the consensus group convened by the ICR include AbbVie, the Association of British HealthTech Industries (ABHI), AstraZeneca, Bioclavis, Bristol Myers Squibb, Leukaemia UK and Precision Life.

The statements are calling for a series of changes in the way biomarker tests are developed, made available and routinely used in the UK:

• All people with cancer should have their cancers molecularly profiled as standard within the NHS to identify mutations and guide their treatment – helping them access more personalised and effective treatments, both as part of standard care and by taking part in clinical trials.
• The NHS should be using panel tests to assess many different biomarkers at once – not only at a patient’s diagnosis, but also at intervals afterwards so treatment can be adjusted in line with changes in the cancer.
• Biomarker tests should be routinely developed alongside new cancer drugs to ensure that the right patients are treated, and the cancers are targeted more effectively. Regulations should be reformed to make it much easier to assess biomarkers in trials and get them approved for use.
• The UK’s health technology assessment bodies, such as NICE, should take a more positive view of companion biomarker tests for new drugs – the UK could explore the possibility of offering incentives for companies that bring forward biomarker tests alongside new treatments.
• The NHS should develop a broader and more transparent directory of biomarker tests, including all the non-genomic biomarker tests that the NHS will provide alongside gene tests.
• Patients and clinicians should be better informed and more aware of the biomarker tests available to them and their benefits. There is currently wide variation in access to biomarker tests in different parts of the UK.

Regulatory barriers to biomarker testing and development have a direct impact on patients – potentially denying them more personalised treatment.

Biomarker testing and development is expensive – currently, the costs of developing biomarker tests often outweigh the financial benefits of doing so, discouraging industry and academia from investing in biomarker research.

But targeting therapies to those who are most likely to respond would be more cost-effective for the NHS. And clinical trials that use biomarkers to select patients are much more likely to succeed and result in marketing approval.

The ICR and the rest of the consensus group members hope that the calls to action in the new 13-point set of consensus statements will help speed up development of biomarker tests and widen access to them – so that the best treatments can reach the right patients as quickly as possible.

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said:

“We believe every cancer patient should have the opportunity for their cancer to be molecularly profiled to assess biomarkers that can give vital clues about how their disease should best be treated. Biomarker tests can direct treatment precisely to the patients who will most benefit, which can both improve the lives of patients and increase the cost-effectiveness of treatment for the NHS.

“It’s essential that the regulations that govern clinical trials and the approval of new tests and treatments keep pace with the rapidly moving science. At the moment, it can be hard to get new biomarker tests developed, approved and made available for patients. That can in turn act as a disincentive for companies and academics to develop new biomarkers to guide treatment in the future.”

Dr Jennifer Harris, Director of Research policy at the ABPI, said: 

“All patients, including cancer patients, should be able to get the best treatments available for their condition.

“Biomarker tests provide crucial information to help doctors select the treatments that will have the best chance of success in each person.

“Overcoming the barriers to developing and using biomarker tests would be a big step forward for personalised care. We will continue to work with the ICR and other partners to help make this happen.”

Sally Hayton, 57, from Manchester, was diagnosed with stage 4 ALK+ lung cancer in December 2013. She said:

“It was a bit of a shock when I was diagnosed. Early in 2013, I had a cough. A CT scan showed an issue with my lung, but I was told it was nothing to worry about. Then one day at work in November, I started to lose sight in my right eye. An optician referred me to A&E at our local eye hospital, and a consultant there said I had a tumour behind my eye. A biopsy was taken from the tumour, and a couple of weeks later the results showed it was a secondary tumour and the primary tumour was actually in my lung. It was a total shock. I was 49, and I had never smoked.

“At that point I was told that I had only 10 months to live, but a tissue sample was sent to test for biomarkers and the results showed that I had an ALK mutation. Because a mutation had been discovered, it meant I could be matched to a targeted treatment. This worked for almost four years, then I was moved on to another targeted treatment called brigatinib, which I have now been on for over three years.

“Biomarker testing can be life-changing. Before I started on the targeted treatments, I had chemotherapy, and the difference in side effects was massive. It’s essential biomarker testing becomes mainstream. If a mutation shows up with a specific treatment available for it, that could give people extra years and a higher quality of

life.”

Read the Consensus Statements on biomarkers: http://icr.ac.uk/biomarkers