The world is on the cusp of a cancer-vaccine revolution that has been years in the making and that will transform cancer care. The number of mRNA cancer vaccines in development has more than doubled since 2017, with 21 in development globally in 2022.
The United Kingdom is at the forefront of trials in therapeutic cancer vaccines. A wealth of clinical and research knowledge combined with political appetite for these cutting-edge technologies is catalysing their rapid development. The government is rightly taking action to attract further R&D investment to our shores and to make the UK’s systems ready to roll out these innovative treatments.
Earlier this year the government signed a deal with BioNTech to provide 10,000 patients with access to personalised, immunisation-based cancer treatments by 2030. This is a fantastic step forward, but the UK needs to go further to capitalise on its potential to lead the world in the development and delivery of these vaccines. Constrained clinical-trial and regulatory capacity alongside limitations with National Health Service (NHS) delivery infrastructure mean there are still substantial risks that cancer vaccines may not live up to their promise in the UK. If these barriers are not addressed, patients across the country and our life-sciences sector will lose out.
The Future of Cancer Treatment
In the coming years, treating cancer will begin to look very different to today. Employing digital tools would give patients more personalised, immediate and direct access to services, leading to earlier diagnosis, and medical advancements could lead to increasingly targeted treatment options, including therapeutic cancer vaccines that target specific genetic mutations in an individual patient. With these developments, cancer treatment will become more timely, effective and convenient, which will allow the NHS to increasingly bring care into the community, freeing up capacity and resource across secondary care.
Therapeutic cancer vaccines are crucial to this vision of the future. They are engineered to train the patient’s immune system to recognise specific cancer “fingerprint” proteins to generate an immune response that kills the cancerous cells. There are two broad categories of therapeutic cancer vaccine. Individualised mRNA cancer vaccines target a patient’s specific cancer, not found in a patient’s normal cells, following genetic sequencing of the tumour. These are highly effective but expensive and complex to develop and distribute. Alternatively, broad-spectrum mRNA cancer vaccines can be used “off the shelf” to respond to certain types of cancer. They are faster and currently cheaper to produce than their individually targeted counterparts, but can often be less effective.
How to Make This Vision a Reality
To ensure the UK remains at the forefront of therapeutic-cancer-vaccine development and delivery, the government should:
1. Commit to the rapid delivery of commercial clinical trials for cancer vaccines. As set out in Lord O’Shaughnessy’s review of clinical trials in the UK, the uptake of participants in commercial clinical trials declined between 2017 and 2022, with the number of trials taking place in the UK falling as well, recovering slightly this year. This is concerning as it reduces both opportunities for UK patients to access the latest treatments and the appeal for investment in the UK life-sciences sector.
To deliver on the potential for UK cancer-vaccine trials, the government therefore needs to assign national clinical investigators to oversee trial delivery for each of the major cancer types. These individuals should be empowered to identify hospitals and other settings that can support trial delivery, work with industry to start trials, and recruit participants quickly.
This would enable cancer-vaccine trials to start in around 90 days; much less than the current 200 days through the centralised National Institute for Health and Care Research route.
2. Develop regulations to ensure new cancer vaccines get to market quickly. Careful regulation is needed to ensure the safety and efficacy of personalised mRNA vaccines in a large and diverse population of cancer patients.
While the Medicines and Healthcare products Regulatory Agency (MHRA) has been awarded £10 million to fast-track innovative medical products, there are reportedly serious capacity and capability constraints within the regulator. These skills gaps need to be filled before regulation can commence at the pace required.
The government should work to deliver on recommendations in Dame Angela McClean’s recent review, which looked at barriers to adopting new technologies and opportunities for regulatory change to accommodate them. Recommendations include building a “skills pipeline” to ensure there is longevity in expertise and knowledge sharing between regulators and industry, as well as supporting regulators to engage with new technologies and deliver them to market with appropriate regulation.
The UK also needs to contribute to the creation of new regulatory approaches and international standards for these innovative treatments. Building collaboration between the MHRA and other leading regulatory bodies such as the US Food and Drug Administration and expanding collaborative vehicles like Project Orbis are critical first steps to establishing these standards.
3. Establish a regime for assessing the clinical and cost effectiveness of cancer vaccines. Evidence about how to optimise the implementation of these new treatments will have implications for how cancer vaccines are used. For example, it may be most effective to use generic therapeutic cancer vaccines as a first-line treatment for most patients, with bespoke vaccines offered if patients fail to respond.
As bespoke vaccines are tailored to every individual, they would incur substantial cost. The National Institute for Health and Care Excellence (NICE) will therefore also need to work with NHS England to consider innovative assessment and reimbursement models for these personalised vaccines. This should include an examination of potential outcomes-based payments and other innovative models available under NHS England’s Commercial Framework.
4. Create the delivery infrastructure necessary to roll out novel treatments. The NHS has been slow to adopt innovative medicines and accelerate their rollout. The UK has a world-leading R&D base for cancer vaccines. Now we need a plan to move towards delivery. NHS England should appoint a lead to oversee the plan for delivery of cancer vaccines to guarantee their seamless entry into the cancer-treatment pathway, including getting clinicians on board with adopting these new technologies.
Use of these technologies requires early diagnosis, which depends upon patients being able to easily and routinely access services within their community. Community diagnostic centres therefore need to be conveniently located and accessible for the whole population to avoid exacerbating health inequalities. Delivery of cancer vaccines must be integrated into existing community health-care settings, including pharmacies, to provide easy patient access. This will allow innovative cancer care to be provided alongside existing treatments and advice from community specialists to support medicine adherence and enable better long-term condition management.
The potential of new cancer-vaccine technologies is hugely exciting, and the UK is well placed to lead the world in their development.
But unless we also have the processes and plans in place to roll these technologies out at scale over the coming years, their potential will not be realised and patients across the country will miss out.