Innovation of Oncology - Q4 2020

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Q4/ 2020

Innovations in

Oncology Read more at www.healthawareness.co.uk

The first ever superresolution microscopy image taken of focal adhesions – molecules inside cellular structures which help cancer cells move and spread around the body. © I A N J O N E S , D R LU CAS D E NT, A N D P R O FE S S O R C H R I S BA K A L / I C R

“Could early detection be the key?”

“Radiotherapy has been the cornerstone of cancer therapy for decades.”

“A huge step forward for these patients.”

Professor Caroline Dive European Association for Cancer Research

Professor Anthony Chalmers Chair of Clinical Oncology, University of Glasgow

Professor Fabrice André European Society for Medical Oncology

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We will always be here to help whatever 2021 may bring

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Innovation and a roadmap: the way to early detection Better early cancer detection could save thousands of lives. We have the technology and the infrastructure. Now a roadmap shows the way to cut through the barriers.

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Living with cancer is always difficult, but feelings of fear, stress and even trauma have intensified during the pandemic.

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n our 23 UK centres we hear of worsened outcomes, extreme loneliness and people with limited time watching the last months of their lives tick away, when they should have been spending quality time with family.

Coronavirus has overshadowed cancer, yet we know that our evidence based practical, emotional and psychological support is needed now more than ever.

Dr David Crosby Head of Prevention and Early Detection Research, Cancer Research UK Written by Linda Whitney

The technology is here Dr David Crosby, Cancer Research UK’s Head of Prevention and Early Detection Research, says: “Blood tests and breath tests are in the pipeline, and we already use various imaging modalities for early detection. Now artificial intelligence (AI) can analyse images effectively enough to select those that need checking by radiologists. As a result it will reduce the bottleneck in image checking currently slowing diagnosis and machine learning may mean technology can ultimately spot early-stage cancers invisible to humans.”

Wearable technology is already used to monitor cardiovascular conditions and diabetes. In future wearables could be used to detect cancers.

The new technologies for early detection could be made available

There are extraordinary moments around our kitchen tables where people of all ages, backgrounds and circumstances naturally and easily support each other through shared experience.

Providing virtual support Earlier this year we shifted our focus to supporting people by phone, email and online – and over the course of three months, supported people 60,000 times.

But, while we understand the need for such support is still there, we also know how important it is for people to come into our centres and see people face to face.

Not only is there a depth of quality and understanding to the support our cancer support specialists and psychologists offer in person, our centres also play an important role in making people feel safe, warm, secure and comforted.

People always say they feel a weight lift from their shoulders the moment they walk through our doors. There are extraordinary moments around our kitchen tables where people of all ages, backgrounds and circumstances naturally and easily support each other through shared experience.

Be it in person or by phone though, my message for 2021, whatever it may bring, is clear – people need expert psychological support more than ever and Maggie’s is best placed to provide that.

Dame Laura Lee Chief Executive, Maggie’s

Read more at Maggies.org

arlier detection offers probably the single biggest opportunity to save lives from cancer. Currently only 55% of cancers are detected at an early stage in England, when it’s often easier to treat, and treatment is more likely to be successful.

Now the Roadmap for the Early Detection and Diagnosis of Cancer, drawn up by Cancer Research UK after consulting over 100 experts, sets out how co-operation between clinical specialists, researchers, technology experts, the health system, government and the public could smash the barriers to spotting cancers earlier.

through the existing network of GP surgeries and clinics.

Breaking down barriers Our current fragmented approach to early detection is a barrier to progress. “We need cohesive action across sectors and players including biologists, medical engineers and economists,” says Dr Crosby. “The roadmap would bring them together to create biologyinformed technologies that deliver tests and prognoses for action that are economically realistic.”

Moreover developing and testing detection technology is expensive and can take years. “Companies are reluctant to invest so few tests make it into production,” says Dr Crosby. The roadmap recommends creating an incubator where companies can access funding to develop early detection tests, and business expertise to help commercialise them.

Public co-operation is essential.

“Listening to what the public wants from tests, how they want to access them, and data security, are essential,” says Dr Crosby.

“Government investment will initially be needed for research, development, communication and implementation but once the roadmap is started, the opportunities are huge,” says Dr Crosby.

“Thousands of lives could be saved and cancer treatment costs reduced. By harnessing the unique platform of the NHS, the UK could become the world’s leading testbed for early cancer detection.”

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We must not lose momentum in cancer innovation While COVID-19 has brought immense challenges to R&D and the delivery of cancer care, it has also shone a light on the value of innovation and how important it is we keep up the pace.

Dr John Fleming UK Country Medical Head Oncology, GSK

Marc Clausse UK Oncology Business Unit Head, GSK

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cancer. This year has brought unprecedented challenges to all teams working to achieve this, yet, at every hurdle, solutions have been found.”

Continuing to drive scientific innovation in the face of COVID-19 Our belief is that by leveraging the power of patient-driven science and technology, we can ensure the therapies we develop are providing a potential solution for unmet medical needs in cancer.

At GSK Oncology, we have been focused on progressing our work investigating small molecules, antibodies, antibody drug conjugates and cellular therapies - working towards delivering the next generation of medicines.

We hope these will bring transformational improvements in patient outcomes as opposed to incremental benefits. Alongside keeping our essential workers safe in our labs and manufacturing sites, this has required a concerted effort to work more collaboratively and efficiently than ever before.

Dr John Fleming, UK Country Medical Head Oncology at GSK says: “We have been working hard to ensure that we don’t lose sight of our ambition to maximise survival and quality of life for people in the UK living with

Progress that can help people with cancer must not stop The R&D approach we are taking is also increasingly becoming disease-agnostic - not looking at particular cancers, but rather how we can harness the power of immunology, genetics and advanced technologies. By understanding the potential commonality across tumour types, we can glimpse how to translate benefit across several cancers and apply this logic to innovate across a range of tumours.

In addition to conventional methods such as blocking a cancer cell’s ability to grow and spread, we are exploring alternative approaches. We believe there is a role for agonists to embolden the immune system either alone as maintenance to prevent recurrence, or in combination with antagonists or ‘blockers’.

One early pipeline example of an agonist at GSK is a programme that addresses the STING pathway (Stimulator of Interferon Genes), which looks at how we can stimulate the immune system to mobilise a patient’s adaptive immune response to cancer.

The potential of our R&D approach was apparent before the pandemic hit; and we are determined that patients should not miss out through unnecessary delay.

ver the past few weeks, we have seen the world unite in celebration as the first COVID-19 vaccines begin to show promise. Yet for those on the front lines of cancer innovation and delivering cancer care, it is likely to be months, perhaps years, before services fully recover.

However, recovery efforts may be quicker than we imagine, and have the potential to shape a new standard of care in cancer.

Looking at innovation beyond the lab Beyond the medicines we research, develop and provide to health services, we also strive to look at other needs: at how we can improve understanding of different cancers, raise vital awareness and improve patient support.

Marc Clausse, UK Oncology Business Unit Head at GSK says:“Regrettably, this pandemic has been devastating to cancer services. Too many people have missed out on care that could have prolonged or improved their lives as a consequence.

Industry has shown its willingness to provide support and the determined examples of collaboration with government and the NHS have been heartening to see.”

In the last few months, GSK has collaborated with the clinical community and hospitals to deliver a homecare package for women with advanced ovarian cancer – enabling patients to avoid hospital visits. Examples like this are being seen across the UK and show again that innovation is not just taking place in the lab – it is also in how we are finding solutions to support patients and the NHS in this challenging time and beyond.

We firmly believe that when we do emerge from the disruption we find ourselves in, we will do so stronger and better equipped to deliver a new standard of care in cancer.

Read more at gsk.co.uk

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Early detection for transformative cancer patient outcomes

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Whilst a lot of progress has been made in personalised cancer medicines, there is still a lot to learn in order to take the next step in the war on cancer. Could early detection be the key?

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wealth of data tells us that detecting cancer earlier brings patient benefit. If we know this is critical, then why have breakthroughs been sparse? Part of the answer is because it is so challenging to achieve.

Professor Caroline Dive CBE Director CRUK Manchester Institute Cancer Biomarker Centre, University of Manchester, UK and President of the European Association for Cancer Research

Where are the knowledge gaps?

Basic research on the biology of early cancers has not yet received sufficient attention. Early detection research requires large clinical studies, multidisciplinary teams and a substantial amount of funding. Better preclinical models of early cancers are needed to understand the early events at the molecular level that occur within a developing tumour and its impact on surrounding normal tissues.

The earliest changes in the immune system as a tumour begins to develop are incompletely understood. Picking up tumour specific changes with a non invasive approach in asymptomatic individuals seems a very tall order.

Moreover, if non-invasive biomarkers are developed that do not pinpoint the location of tumour, at a timepoint when resolution of imaging approaches to guide surgery is not possible, how will these individuals be managed? The challenge of over diagnosis looms large as early biomarker tests emerge and these tests will need to distinguish indolent (leave them alone) from aggressive (intervene early) lesions.

Liquid biopsies for early cancer detection The liquid biopsy field (the diagnosis or analysis of tumours using only a blood or fluid sample) has

exploded in the past decade. Circulating proteins (e.g. prostate specific antigen) are established in clinical use and circulating nucleic acids are routinely used testing for prenatal testing.

Liquid biopsies are entering cancer clinics to predict treatment benefit, but their impact to identify molecular profile consistent with early and aggressive tumour formation has yet to be delivered as a screening test.

However, the progress being made with circulating tumour DNA (ctDNA) in the bloodstream is truly exciting, where a methylation profile acts as a tumour zip code. The final push may be a multimodal approach, where methylated ctDNA and ctDNA fragment size add power to mutation detection, with circulating tumour cell analysis that yields the tumour genotype (genetic constitution) and phenotype (observable characteristics) of aggressive early invaders.

Who do we screen?

Should we ‘fish’ in a well stocked lake (a high cancer risk cohort) or in the ocean (whole population) to develop our early detection liquid biopsies? Both approaches are underway, with cancer specific (e.g. high risk for lung cancer) and pan cancer studies ongoing.

Finally, could we see more early detection in the future? It’s Tuesday, your device buzzes, a reminder to put your bi-monthly blood sample in at your community pharmacy for cancer screening. Well, I wouldn’t bet against this vision becoming reality.

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Making the fractions add up: new radiotherapy techniques and the impact of COVID-19

consequently seen a rapid uptake of highly innovative changes in radiation oncology that previously may have taken years to implement. It is hoped that this paradigm of “forced agility” due to coronavirus may ultimately be a key driver in equitable access to high-quality radiotherapy for all cancer patients in the future.

Referemces 1. Kishan AU, Dang A, Katz AJ et al. Long-term outcomes of stereo-tactic body radiotherapy for low-risk and intermediate-risk prostate cancer.

JAMA Netw Open 2019;2:e188006 2. Jackson WC, Silva J, Hartman HE, et al.

Stereotactic body radiation therapy for localized prostate cancer: A systematic review and meta-analysis of over 6,000 patients treated on prospective studies. Int J Radiat Oncol Biol Phys 2019;104:778-789.

Radiotherapy is a fundamental oncological treatment, playing a critical role in both curative and palliative cancer care.

Dr Hannah Tharmalingam Vice President for Clinical Oncology, The Royal College of Radiologists

New delivery of radiotherapy However, innovative developments in four-dimensional planning systems and advances in image-guidance have resulted in techniques, such as stereotactic ablative body radiotherapy (SABR), which allows for far more precise local delivery of radiation, better sparing adjacent normal tissue and delivering much larger daily dose fractions.

Curative radiotherapy for prostate cancer, for example, can now be “hypofractionated” and delivered over five days as opposed to four weeks, considerably improving the experience for patients and reducing hospital workloads. Substantial evidence supports this, with two large-scale meta-analyses of men treated with SABR for prostate cancer showing excellent cure rates and a favourable side effect profile.1,2 Moreover, concerns around increased toxicity can now be further allayed by the use of other

pioneering technologies, such as the hydrogel rectal spacer. This is a biodegradable device inserted directly into the region between the rectum and the prostate to position the former away from high-dose radiation during treatment.

Despite these innovations, widespread uptake of hypofractionation has been slow. A critical limiting factor is an economic model where radiotherapy services are financially reimbursed per fraction, disincentivising the adoption of shorter regimes and stereotactic techniques.

How coronavirus has accelerated uptake Paradoxically, however, it may be that the COVID-19 pandemic has a long-lasting positive impact in this respect. The urgent need to reduce patient footfall through radiotherapy departments has significantly accelerated the adoption of evidence-based hypofractionated radiation.

Concurrently, the NHS payment model has been temporarily changed to a “block” tariff where centres are reimbursed for a course of radiotherapy, irrespective of treatment fraction numbers or type.

The last six months have

©DR_MICROBE

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ide effects occur as a result of radiation to normal tissue close to tumour targets.

To minimise these effects, treatment has conventionally been delivered in small daily doses, termed “fractions”, over multiple weeks to allow normal tissue to recover.

We are in the business of breakthroughs – the kind that transform patients’ lives.

Dedicated to our mission of discovering, developing and delivering innovations that help patients prevail over serious diseases and strengthen our communities. We’ll never give up on our search for more hope, for more people, around the world.

Visit bms.com/gb to see how we’re bringing a human touch to everything we do. © 2020 Bristol-Myers Squibb Company. All rights reserved. November 2020 NOUK2000982-10

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The immunology radiotherapy therapy double act

Digital surgery in the hands of the surgeon Surgeons are integral to lead the technological advances for digital surgery.

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espite advances in chemoradiotherapy, surgery remains the main modality for treatment of resectable rectal cancer. The last decade has seen significant technological advances and treatment developments. Improved diagnostics, development of new surgical tools, and enhanced vision-systems have lead surgeons into the era of digital surgery.

Surgical innovation and robotics “The surgeon” remains integral to improving the survival of colorectal cancer patients. Good quality surgery as a result of sound surgical technique leads to reduced local recurrence and improved survival.

The recent advances in technology and tools have allowed surgeons to use minimal access surgery and the laparoscope for Total Mesenteric Excision (TME) surgery. Some of the inherent difficulties of laparoscopic surgery such as 2D image, a fulcrum effect, limited access to a narrow pelvic area and amplification of tremor have been overcome by the increased use of robotic technology for TME surgery.

Robots offer a 3D view, along with endowrist instruments and stability of the operating platform.

This precision allows surgeons to replicate the principles of open TME surgery in a minimal access fashion.

Developing for the future With significantly increased interest in use of robotics in general surgery there are about 12 new industry-partners now Dr Afsana Elanko Director of Education, British Association of Surgical Oncology (BASO - The Association of Cancer Surgery)

investing in developing and creating new systems to launch over the coming years.

Apart from improvements in surgical navigation and imaging overlay, there is hope to use artificial intelligence to a level where the surgeon may oversee the performance of robotic platforms like the use of autopilot in the airline industry.

With the use of big data, machine learning and quantum computing, there is a potential for huge growth in this area. These newer robotic technologies are not cheap and the current systems are expensive to buy and run, as the cost of consumables remains high.

Investing for innovation Investment in robotic surgery is allowing industry partners to develop technologies such as enhanced vessel sealing capabilities with energy sources, the use of fluorescence techniques for blood supply assessment and lymph node drainage.

The concept of surgical navigation is being developed, where the surgical oncologist will be guided by the tools available in robotic surgery to perform better cancer clearance and achieve improved survival for such patients.

We are entering the era of digital surgery where like our cars, home entertainment systems and phones, we will have many add-ons that will enable surgeons to perform complex cancer surgery safely with minimal collateral damage and improved survival for our patients.

Mr Jim Khan Consultant Colorectal Surgeon; Clinical Director, Portsmouth Hospitals NHS Trust; Trustee, BASO (The Association of Cancer Surgery)

Understanding the immune response to radiotherapy will create exciting opportunities to identify novel therapeutic targets and enhance the efficacy of cancer immunotherapy.

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arnessing the immune response to treat cancer is not a new concept. However, recent advances in this area have transformed the treatment of certain cancers, dramatically increasing life expectancy even for patients with metastatic disease.

For many cancer types, immunotherapy has yet to improve outcomes. In contrast, radiotherapy has been the cornerstone of cancer therapy for many decades. It has cured a significant proportion of patients and enhanced quality of life when other treatments have failed.

Radiotherapy can also affect the immune environment of healthy tissues, such as the gut mucosa.

Unravelling the mechanisms behind these effects could lead to new therapeutic targets.

It is equally important to note, it may help identify strategies for alleviating the side effects of both radiotherapy and immunotherapy, thus improving patients’ quality of life. The opportunities for scientific discovery at the intersection of these research areas are immense. They have genuine potential to create new and more effective treatment strategies for a broader spectrum of cancer patients.

The opportunities for scientific discovery at the intersection of these research areas are immense.

It may help identify strategies for alleviating the side effects of both radiotherapy and immunotherapy, thus improving patients’ quality of life.

Integrating novel approaches to maximise patient benefit Recent innovations in radiotherapy and imaging technologies have massively increased the precision with which radiotherapy can be delivered. This trend is set to continue with the emergence of protons and other advanced radiation modalities.

What happens when we combine advanced radiotherapy techniques with immunotherapy?

It depends on the cancer in question, but in some cases radiotherapy appears to stimulate the immune system, encouraging it to attack cancer cells thereby improving responses to immunotherapy.

Strikingly, this stimulatory effect is sometimes seen in distant tumours that did not receive radiotherapy, as well as the irradiated tumour.

This ‘abscopal effect’ remains relatively uncommon, however, it is not yet fully understood how radiotherapy overcomes the ability of tumours to suppress the immune system. Complex immunological phenomena such as organ cross-talk and concomitant immunity have recently emerged as possible drivers of the radiation effects.

Collaborating across disciplines To fully exploit the immune system’s response to radiotherapy and improve patient outcomes it is vital to work across disciplines. We need to create an environment that promotes and nurtures interaction between immunologists, cancer researchers and clinicians to facilitate translational research activity.

The British Society for Immunology and the National Cancer Research Institute have recently partnered on an initiative to maximise collaboration in this area. The ultimate goal is to accelerate translation of cancerrelated immunology research into life-saving outcomes for cancer patients.

To find out more about the initiative visit ncri.org.uk

Professor Anthony Chalmers Chair of Clinical Oncology, The University of Glasgow

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Networking to improve radiotherapy – in a flash!

A new network of UK centres of excellence is set to revolutionise health outcomes in the field of radiobiology and radiation oncology.

Professor Anderson Ryan Department of Oncology, University of Oxford

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Advancements in radiotherapy Recent innovations in radiotherapy include the development and subsequent introduction to the UK NHS of proton beam irradiation, a therapy which hit the headlines in 2014 following a legal battle involving the parents of child cancer patient Ashya King.

In addition, ultra-high doserate (‘FLASH’) irradiation has become a hot topic of research for both standard (photon) and proton beam irradiation because laboratory research has shown that FLASH is a very effective anti-cancer treatment with less side-effects than conventional radiation.

However, major gaps still remain in both our understanding of the basic biology that underlies the effectiveness of these innovations, and how these can best be combined with other therapies such as immunotherapy,

which could seriously limit their future deployment into the clinic Equally, no biomarkers are yet available to predict which new treatments will give the greatest efficacy and least side-effects for individual patients.

The importance of networks Professor Ryan is particularly excited by a new research network initiative (RadNet), spearheaded

by Cancer Research UK. RadNet is a network of seven UK centres of excellence, each with distinct but overlapping areas of speciality in radiobiology and radiation oncology. By bringing together academic and clinical expertise across the country, the £56 million 5-year CRUK programme aims to catalyse and accelerate advances in radiobiology knowledge and clinical practice that can address the current gaps in our understanding and translate novel scientific discoveries into patient benefit within 10–15 years.

Professor Ryan believes the commitment of CRUK to RadNet is particularly welcome: “The funding for this initiative is critical because it brings radiotherapy to the core of our scientific thinking and it gives all the network members a clear and common research goal of significantly improving patient outcomes.

Now the hard work begins!”

Written by Ailsa Colquhoun

©MARK KOSTICH

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adiotherapy has been a key part of curative treatment for cancer patients for decades.

During the past 20 years there have been tremendous technical advances in radiotherapy, but there are still some tumours that either don’t respond well, or even at all, to treatment,” explains Professor Ryan Anderson, senior group leader in oncology at the University of Oxford.

Getting a gut feeling for radiotherapy Oxford University researchers are discovering how gut flora can be modified to improve patient outcomes in radiotherapy.

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Professor Anne Kiltie Department of Oncology, University of Oxford

key area of research is the value of using pro- and prebiotics in protecting patients against radiotherapy induced gut injury.

“We know that many patients can suffer from radiation induced injury, for example, diarrhoea, or, more rarely, long-term fibrosis. So, the potential gains for patients are significant,” says Professor Anne Kiltie, Professor of Experimental Clinical Oncology, at the University of Oxford.

Recent studies have highlighted gut microbiota modulation as a way of maximising treatment efficacy in chemotherapy and immunotherapy, but little research exists for this application in radiotherapy.

Even though over half of people with cancer will receive this therapy, often with curative intent, radiotherapy is comparatively under-researched.

Redressing the research imbalance As one of the research centres in the new CRUK RadNet network, Oxford University is now looking to redress this imbalance. Recent studies have looked at the application in radiotherapy of antibiotics to enhance the anti-tumour efficacy and the abscopal

effect of the treatment.

Professor Anne Kiltie and her team are now looking to see whether a similar effect can be achieved by using high fibre as a way of radiosensitising a tumour – opening up the possibility of more effective and targeted treatment.

Among the fibre products now being investigated is psyllium, which is already widely used and available as an ingredient in simple over the counter medicines for constipation. Studies centre on the effect in the gut of the short chain fatty acid butyrate, which is a by-product of dietary fibre, and which is essential for healthy gut function. Studies suggest that butyrate can accumulate in the tumour and make it more sensitive to radiation.

Currently, research is still at an early stage, but the research team is hopeful of moving into human trials soon. “There is a lot of value in seeking effective alternatives to antibiotics. Initial results are very promising,” says Professor Kiltie.

Written by Ailsa Colquhoun

Chee Kin Then DPhil student, Department of Oncology, University of Oxford

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Helping to bring precision medicine to patients Pioneering new guidelines on multigene next-generation sequencing are bringing innovative treatments to patients with cancer.

N Professor Fabrice André Previous Chair of the ESMO Translational Research and Precision Medicine Working Group, Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France

ovel technologies now make it possible to sequence hundreds or even thousands of genes in a short time frame. Treatment can be selected according to the genomic alterations in a tumour.

The European Society for Medical Oncology (ESMO) has led the way in publishing recommendations on the use of multigene nextgeneration sequencing (NGS), providing practical advice for cancer centres on the value of this technology to deliver precision medicine.1 1. Use NGS for certain cancers ESMO recommends the use of multigene NGS in patients with some advanced cancers – for example, lung, prostate, and ovarian cancer. This is the first advice from a scientific society and a huge step forward for these patients.

©TETIANA LAZUNOVA

2. Enrol patients in clinical trials Participation in clinical trials

can be a route to innovative treatments. ESMO recommends that clinical research centres offer multigene NGS to patients with cancer as part of their mission to enable access to novel therapies.

In addition to giving more treatment options, this approach generates much needed evidence on the use of this technology in other tumour types. It also accelerates development of drugs targeting specific mutations.

3. Patients at the centre Individual patients can have an outlier response to extremely rare and unexpected, potentially clinically useful, genomic alterations. While this is likely a very small percentage of patients, ESMO acknowledges that patients and their clinicians should have the option to order a multigene sequencing test provided there is no cost to the public healthcare system.

Patients need to be made aware that finding a previously

unidentified mutation by examining a large panel of genes is uncommon. But ESMO believes that patients and their doctors should have the freedom to decide to investigate the possibility.

ESMO developed the recommendations based on the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) ranking for genomic alterations occurring in eight cancers. Experts used the ESCAT ranking and prevalence of alterations to calculate the number of patients that would need to be tested with NGS to identify one patient who could be matched to an effective drug in daily practice.

References 1. Mosele F, Remon J, Mateo J, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020 Aug 24:S0923-7534(20)39971-3. doi: 10.1016/j. annonc.2020.07.014.

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How a CRO can speed up cancer drug development How the end-to-end services only available from a contract research organisation can be key to speeding up the development of immuno-oncology drugs.

Ken Morrison, PhD Vice President, Oncology, Covance

End-to-end expertise “Companies that are developing their oncology assets need a partner with the capability and understanding to support all the elements of the asset journey, ensuring optimal service delivery aligned with client and patient needs,” says Morrison. “This dictates the overall success of the program.”

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What’s needed now Cancer Vaccine Development: Triggered by the accelerated development strategies for coronavirus vaccines, companies are inspired to accelerate development of cancer vaccines.

Swift development of therapeutics for cancers where timelines are compressed, in both solid and haematological malignancies, where increasingly assets are tumour-agnostic and genetic mutation and / or Biomarker specific.

©NICOLA FERRARI

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hen it comes to access to immuno-oncology therapies, cancer patients cannot wait.

However, the journey from lead asset identification to registered clinical treatment typically takes 5-10 years depending upon the therapeutic.

There are ways to make this journey faster and efficient, says Ken Morrison, Vice-President of Oncology at Covance Clinical. As a global Contract Research Organisation (CRO) supporting preclinical and clinical development across all therapeutic modalities in oncology, plus diagnostic services and expertise, Covance and parent company LabCorp support cancer drug developers.

“Clients can leverage the value of integrating diagnostics with drug development services,” says Morrison.

This is the only CRO in the world that can diagnose and genetically profile a cancer patient, and then support their enrolment in a suitable clinical trial to help identify a new vaccine or therapy while monitoring safety throughout treatment. “The expertise between Covance and LabCorp allows for accelerated decision making in drug development ,” says Morrison.

Cell or gene therapy in haematological and solid tumour disease: Unique non-clinical humanised mouse models, use of Organoids with specialist analysis are being adopted to assess the target activity of lead assets. There is also an exponential use for biomarker assays in cancer patient selection, unique characterisation of the chemistry, manufacturing and controls (CMC) required to support batch release. Plus identifying the right patients based on biomarker targets, then measuring response and long-term follow-up requirements.

From multivalent biologics, to other targeted biologic therapies including biosimilars engineered to influence the immune system, the linking of scientific targets throughout the development continuum can create a time-efficient approach to lead generation. Streamlined regulatory engagement from this point focused on CMC, non-clinical and clinical plan perspectives is critical to enter into the clinic expeditiously.

Identifying practical solutions “We are seeing more efficient target identification, validation, and testing in non-clinical environments coupled with early regulatory consultation to ensure efficient access to the clinic.

We also need a continued focus on driving faster, data-driven decision making throughout the development process especially in clinical,” says Morrison.

That means connecting data and cross functional development teams to make decisions, with a defined governance structure to make decisions faster.

Meanwhile, blended services and data integration will avoid sponsors shopping around for, and outsourcing to, multiple partners, saving time to market.

Clinical feasibility studies that incorporate all knowledge of the program enable faster start up to first-in-human trials.

What should clients look for?

Morrison recommends seeking: • A preclinical oncology service offering unique models fostering efficient data-driven lead generation. Services spanning all aspects of entry into the clinic, including all facets of investigational new drug (IND) and clinical trial application (CTA) enablement, are also must-haves.

• The ability to select the patients most likely to benefit from therapeutics under development, by the use of biomarker detection assays and diagnostic services, plus specialty clinical pharmacology testing & analysis capabilities.

• Finally, global trial capabilities intertwined with central labs support to ensure flawless execution of trials and manage complex logistics associated with the movement of patient samples.

“Working with a CRO partner with expertise in the continuum of drug development, coupled with diagnostic capabilities ensures the efficient application of precision medicine strategies in cancer drug development, supporting faster data-driven decision making,” says Morrison.

Written by: Linda Whitney

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Innovative, patientcentred treatments need adaptive clinical trials As our knowledge of cancer and how to treat it has grown and evolved, there has been a clear need to innovate the way we do clinical trials.

Sarah McDonald Director of Research, Myeloma UK

Adaptive trials are designed for flexibility Traditional randomised, controlled clinical trials are linear and designed to answer one specific question. These fixed trial designs work well for treatments like chemotherapy drugs which were developed for a large, generalised group of cancer patients. However, they don’t work as well for more targeted, personalised treatments.

To deliver truly personalised treatments we need innovative trials that provide flexibility and the ability to answer multiple questions simultaneously. This is where adaptive trial designs come in.

Adaptive trials have several predefined review and adaptation points throughout the trial. At the adaptation points, researchers review the data collected from the trial and make changes where required; a trial arm may close, increase in recruitment for a patient cohort or a change in dose or combinations.

This innovation means that several questions can be answered at the same time without impacting the scientific integrity of the study.

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Learning earlier and faster Adaptive designs are particularly useful in the earlier stages of drug discovery where there is more uncertainty and a lot of unanswered questions.

Researchers can merge several traditional trials into one large trial with multiple arms and review stages. This increases flexibility, helps optimise resources, and may require fewer participants.

Being able to learn about a new drug throughout the trial means researchers don’t need to wait until the end of the trial to find out if the drug works. Results are available more quickly helping make drug discovery faster and more efficient.

Adaptive trials are better for patients The real strength of adaptive trial designs is their ability to make trials more patient-focused rather than drug focused.

Researchers can look across multiple patient groups to find the people for whom the treatment works for and why.

The on-going adaptations help maintain the balance between effectiveness and toxicity so the optimal dose is taken forward.

This reduces the number of patients treated with ineffective or harmful drugs at inaccurate doses and maximises the numbers treated on more efficacious arms.

The multi-arm, multi-stage design in adaptive trials means patients can stay in the trial for longer and give clinicians flexibility to consider what the patient needs, letting them adapt treatments and make dosing changes during the trial. This is particularly beneficial for patients who did not respond to treatment, experience severe toxicities, or have relapsed early.

Innovative trials need investment Despite the many advantages of adaptive clinical trials, adoption has been slower than expected.

They need complex statistical work to maintain scientific validity so can take longer to design and be harder to pitch to funders.

To help increase the use of these innovate, patient-centred trials Myeloma UK funds the UK Myeloma Research Alliance- Myeloma UK- Concept And Access Research Programme (CARP) which aims to develop, secure funding and open early phase trials.

The first adaptive trial has secured funding and is waiting to open with several more in the development pipeline. CARP is the only UK initiative focused on the development of innovative early phase trials to meet the needs of myeloma patients so they can access novel treatments up to ten years before they are available through the NHS.

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e now know every cancer is different and that a single treatment or drug won’t work for everyone. Cancer cell biology is diverse and varies between both different types of cancer but also between patients with the same cancer. This is particularly true for a relapsing-remitting cancer like myeloma, where a patient’s cell biology can vary over the course of the disease.

To successfully deliver kinder, more effective treatments for all cancer patients we need more personalised treatments tailored to a patient’s individual characteristics.

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ŠIMAGE PROVIDED BY RUTHERFORD HEALTH PLC

Paid for by Rutherford Health plc

We must not let cancer become a secret killer COVID-19 has placed huge strain on cancer care services across the UK. Without urgent action, it will become a secret killer for many months to come.

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s we grapple with the second wave of COVID-19, it is important for us to maintain perspective on some of the other pressing public health challenges we face as a direct result of this pandemic. Cancer care across the UK has experienced upheaval with terrible consequences for patient outcomes.

By the end of the first lockdown, referrals for cancer were down 70%1 and thousands of cancer patients saw their treatments and diagnostic tests delayed. Whilst treatment of cancer is gradually returning to normal capacity, we continue to face massive challenges with cancer diagnosis.

The latest figures from Cancer Research UK show a 35% drop for chest and abdomen CT scans, 42% drop in brain MRIs and a 39% drop in chest X-rays.2 This is cause for concern, getting a prompt imaging test can be the difference between life and death for some patients.

How to overcome the diagnostic gap To overcome this, we have to act innovatively and collaboratively.

The Government and the NHS have done well to use up spare capacity in the independent sector, but this has not always been utilised to its fullest extent.

We have seen the benefits of this collaboration with our own cancer network, the Rutherford Cancer

Professor Karol Sikora Chief Medical Officer, Rutherford Health plc

Centres, but this needs to be expanded. Using the independent sector can help us plug the diagnostic gap.

Helping tackle cancer backlog Perhaps more worryingly, we face the prospect of thousands of cancer patients coming through the system at once with late-stage cancers in the coming months due to lack of early diagnostic testing. We must prepare for this challenge now. In 2021, we will see a year of the cancer backlog.

Patients may even require advanced treatments such as high energy proton beam therapy due to more aggressive and difficult to treat tumours. With sufficient collaboration and proactiveness, we can face this challenge and ensure that all cancer patients receive the treatments they need without any further delays. We must act now.

For more information about the Rutherford Cancer Centres, please contact us: 0800 210 0402 or visit us at therutherford.com References 1. www.pulsetoday.co.uk/news/uncategorised/ gp-urgent-cancer-referrals-decline-by-morethan-70-as-fewer-patients-come-forward/ 2. www.express.co.uk/news/uk/1363424/ cancer-test-nhs-decline-diagnostic-testscoronavirus-outbreak

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The hope is that, in future, liquid biopsies will replace invasive tissue biopsies in some circumstances.

How research advances are transforming breast cancer treatment Breast cancer is not one single disease – it is different from one patient to the next. Research continues to make significant discoveries to identify these differences, whilst helping patients assess their risk of developing breast cancer and finding the most appropriate treatment for each individual.

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s a result of new research, people diagnosed with breast cancer now live longer than in the past and receive treatments that are “kinder and smarter.” These treatments are more effective at targeting the specific biology of the disease, whilst having fewer side effects.

Read more at healthawareness.co.uk

Tracking cancer using liquid biopsies The rapidly evolving field of liquid biopsies is a key area of breast cancer research that could revolutionise treatment. Until recently, the effectiveness of a cancer treatment could only be monitored by removing parts, or biopsies, of a tumour and scans involving radiation.

Liquid biopsies involve looking for cancer cells or cancer DNA in the blood. This approach is not only simpler for the patient but also has huge promise as a way of monitoring breast cancer and how it responds to treatment – helping guide clinical decisions and ensuring that we stay one step ahead of cancer.

Although still being evaluated in the laboratory and the clinic,

these liquid biopsy tests are likely to be introduced more widely in cancer management. The hope is that, in future, liquid biopsies will replace invasive tissue biopsies in some circumstances.

Bringing new drugs to the clinic and understanding drug resistance The ICR and The Royal Marsden NHS Foundation Trust played a key role in the development of PARP inhibitors, now used in the treatment of ovarian, prostate and pancreatic cancers. These drugs are now set to be game changing for people diagnosed with breast cancer who have a mutation in a “BRCA” gene.

These genetically targeted drugs work by stopping cancer cells from being able to repair their damaged DNA. In the past five years, the drug carboplatin, which also kills breast cancer cells with a BRCA gene mutation has also been established as an effective treatment for breast cancer.

The ICR and Royal Marsden have also played a key role in developing hormonal drugs called aromatase inhibitors that are used to treat breast cancer

Professor Andrew Tutt Director, Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London

in post-menopausal women and tests that show who can have these drugs and avoid chemotherapy. Aromatase inhibitors stop production of the hormone, oestrogen, and often provide an effective treatment that avoids the use of chemotherapy.

There is also a pressing need to improve our understanding of the mechanisms breast tumours use to become resistant to treatment.

At the ICR, we have uncovered how resistance to aromatase inhibitors, CDK4/6 inhibitors and PARP inhibitors develops. We are working to find out how to target this resistance.

Improving radiotherapy regimens The effectiveness of radiotherapy, which is often used to prevent breast cancers returning after surgery, is also being improved by researchers. Despite what many people think, this type of treatment is very precise and often does not come with significant side effects.

After a decade of research, two UK clinical trials have demonstrated that a lower total dose of radiotherapy delivered in fewer but larger doses is both as safe and effective while being more convenient for patients than giving multiple small doses of radiotherapy. Findings from these trials have supported changes in how breast cancer is treated that are already helping relieve pressures on the NHS. It is clear that recent years have led to pioneering discoveries and I am hopeful that, with further research and collaboration, the future will bring even more advances.

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A personalised approach to breast cancer is vital Personalisation in breast cancer research, services, treatment and support is essential, and collaboration is key to deliver it.

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ersonalised breast cancer treatment is not new – every patient is genetically unique, as is their tumour.

However, beyond treatment, it has a critical role in prevention and in supporting patients, says Dr Simon Vincent, Director of Research, Support and Influencing at charity Breast Cancer Now.

Dr Simon Vincent, Director of Research, Support and Influencing, Breast Cancer Now

Paid for by Breast Cancer Now

Leading the way “We are conducting innovative research to identify people at higher risk of breast cancer, so they could be offered more frequent screening to catch any breast changes earlier, and potentially the option of chemoprevention. In addition to patient benefit, this approach promises efficiencies for overstretched NHS resources,” he says.

Breast Cancer Now also funds research to further personalise treatments, including a study to identify genetic changes that occur in tumours which could be exploited to design new drugs. In partnership with Pfizer, the charity is also funding a trial of an existing lung cancer drug as a treatment for

lobular breast cancer in its efforts to create best–tailored treatments for patients.

The charity provides personalised support to patients through its targeted courses and free helpline staffed by nurses, all of which patients can be signposted to. “We want the healthcare practitioner community to know that we can pick up some of the load of supporting patients,” says Dr Vincent.

The impact of COVID-19 The pandemic prompted Breast Cancer Now to rapidly repivot its support services online. “We will return to face–to–face patient support when we can, our online support has removed some access barriers, and we will factor this into our offering permanently,” says Dr Vincent.

Right now, the charity’s work is more vital than ever, because of the many different ways COVID-19 has affected people with breast cancer, healthcare professionals and researchers – from delays in screening, changes in treatment,

We are conducting innovative research to identify people at higher risk of breast cancer, so they could be offered more frequent screening to catch any breast changes earlier. paused clinical trials, and lost hours in the lab.

Partnerships – across universities, pharmaceuticals, NHS, charities, funders, and patients – are integral to bringing hope through breast cancer research. “Partnership working has enabled us to progress our efforts to personalise treatments, such as identifying carboplatin as a better choice of chemotherapy for secondary triple negative breast cancer patients who carry mutations in the BRCA genes; going forwards it’s critical that we harness the power of collaboration.” says Dr Vincent.

Written by: Linda Whitney

Could you support Breast Cancer Now’s innovative world-class research? Whether you’re a potential funder, partner or researcher you can find out more at breastcancernow. org/breast-cancerresearch

Ensuring women with breast cancer go on to live longer, healthier lives ABC Discover The ABC Discover research project was created to improve earlier detection of secondary breast cancer and to better understand the impact of diet and lifestyle on breast cancer recurrence and secondary spread.

Taking place at the University of Southampton, ABC Discover promises to have a major impact on the discovery of biomarkers, which are required for the development of new tools to identify risk and early detection of Stage IV breast cancer.

Our goal is to provide the basis for precision medicine in breast cancer and to improve our understanding of the impact diet and lifestyle has on patient progression and outcome.

ABC Discover hopes to revolutionise treatment intervention to improve patient outcome.

Against Breast Cancer is a registered charity in England and Wales.

Registered Charity No. 1121258

Against Breast Cancer has seen a dramatic downturn in income during 2020, we are working tirelessly to ensure continuity in our research funding. We encourage readers to scan our QR code to learn more about regular giving and how they can support our vital research into secondary spread breast cancer.

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From cancer patient to marathon hero: how the Innovative Cancer Care Fund could save lives The British Liver Trust is joining forces with other health charities to call for improved access to innovative cancer therapies for patients.

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Patients in the UK are missing out Innovative new cancer drugs are made available to patients through the Cancer Drugs Fund. However, other emerging ground-breaking cancer treatments such as ablation or embolisation ‘technologies’ are not included.

Many of these treatments are currently available across Europe, the USA and Canada. However, patients in the UK are missing out.

SIRT has undoubtedly extended my life. I have had precious time with my wife and children – what price do you put on that? ~ Mark Thornberry, aged 59 Health charities, oncologists and other clinicians are calling for access to these types of treatment to be made available through a new ‘Innovative Cancer Care Fund’.

Professor Abid Suddle, a consultant from Kings College Hospital NHS Trust, says, “For some patients, these types of interventional oncology treatments are the most clinically appropriate option and they need to be a key part of the Government’s Cancer Strategy. It is much more difficult to get these treatments through traditional commissioning mechanisms as randomised control trials are problematic due to the small

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Vanessa Hebditch Director of Communications & Policy, British Liver Trust

very day in the UK, 990 people are diagnosed with cancer, while death rates from liver cancer have soared by around 50% in the last decade.

Unfortunately, liver cancer is extremely difficult to treat as patients often have underlying liver disease that must be treated alongside the cancer. There are very few treatment options and only 12% of patients survive for five years.

number of patients who will benefit and the fact that you cannot offer a ‘placebo pill.’”

Mark’s story Mark Thornberry, aged 59, is one patient who has benefitted from these treatments. Diagnosed with liver cancer in April 2017, he was advised that he only had six to nine months to live after his cancer spread following an initial conventional treatment.

At the time, his hospital was participating in a clinical trial for Selective Internal Radiation Therapy (SIRT). This is a type of internal radiotherapy. Radioactive beads are placed into a blood vessel and carried directly to the

tumour site in the liver where the radiation destroys the cancer cells.

For Mark, SIRT proved to be a game changer. The non-invasive nature of the treatment and limited side effects meant he was able to run an ultra-marathon only six weeks after the treatment and his life expectancy has gone up significantly.

Mark said, “SIRT has undoubtedly extended my life. I have had precious time with my wife and children – what price do you put on that? These treatment options should be made available for any patients who might benefit.”

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Every day in the UK, 990 people are diagnosed with cancer, while death rates from liver cancer have soared by around 50% in the last decade. ~ Vanessa Hebditch, Director of Communications & Policy, British Liver Trust

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Findings from these trials have supported changes in how breast cancer is treated that are already helping relieve pressures on the NHS. It is clear that recent years have led to pioneering discoveries and I am hopeful that, with further research and collaboration, the future will bring even more advances. ~ Professor Andrew Tutt Director, Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London

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