Blood health campaign 2017

JUNE 2017

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Blood Health

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Dame Kelly Holmes: “My mother, Pamela, was diagnosed with myeloma in 2015”

CAR-T CELL THERAPY:

Combatting cancer with the body’s own immune system P6 MYELOMA UK:

Myeloma is a very individual disease. No two patients are alike ONLINE PHOTO: GARMIN

D N D NEEEED U EAD U L O O Y U O N Y O THE IR R THE LIFE FO Iron contributes to the reduction of tiredness and fatigue.

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IN THIS ISSUE

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Dr Dan Hart on Haemophilia treatment: one size does not fit all

Diana Jupp, CEO, Bloodwise: “Blood cancer is the biggest killer after lung and bowel”

Dame Kelly Holmes: “Mum’s the reason I highlight myeloma” Read the full story

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What the UK must do to keep pace with blood cancers

Dr Suzy Lishman, President of the Royal College of Pathologists, explains the importance of training enough specialists and receiving sufficient blood donations for our aging population

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lthough great progress is being made in the treatment of blood cancers, such as leukaemia, lymphoma and myeloma, cure for all is not yet a reality.

Most forms of blood cancer are more common in older people. There are over 11 million over 65s in the UK, projected to rise by more than 40 per cent in the next 17 years to over 16 million. As the age of the population rises, so will the number of people developing blood cancers. There are currently approximately 1,200 consultant haematologists – highly trained doctors who specialise in the care of patients with blood cancers – but more are needed. Investment in recruiting and training new Follow us

haematologists must begin now if we are to meet the needs of future patients.

Scientists are also key members of blood cancer teams, developing precise molecular tests to guide the choice of drugs and give early warning of the disease returning. They are instrumental in matching stem cell donors with the patient and in selecting compatible blood.

Dr Suzy Lishman President, The Royal College of Pathologists

The extraordinary gift of donating blood Treatment of blood cancers would not be possible without our precious blood donors. Patients can become very anaemic, due to a combination of the disease and the drugs used to treat it, and often need regular blood

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transfusions. They may also have a low platelet count. These tiny blood components are essential for blood clotting and transfusions of platelets, obtained from donated blood, may be needed every day or two.

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More donors, particularly from a black or Asian background, are always needed. More than 6,000 donations are required every single day to keep stocks at safe levels, and 200,000 new donors are needed every year.

Giving blood is quick and easy, and you might help save someone’s life.

NHS Blood and Transplant (to donate in England) www.blood.co.uk Welsh Blood Service www.welsh-blood.org.uk/ giving-blood Scottish National Blood Transfusion Service www.scotblood.co.uk Northern Ireland Blood Transfusion Service www.nibts.org

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COMMERCIAL FEATURE

Current Challenges in Treating Acute Lymphoblastic Leukaemia – The Road Ahead Erytech is developing treatments for ALL through research and clinical trials. Dr Susana Rives, a consultant paediatric haemotologist for the University Children’s Hospital in Barcelona, explains the developments in ALL research

By Shauna McCrudden

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cute Lymphoblastic Leukaemia (ALL) is the most frequent cancer in childhood.

It is a cancer that originates in the bone marrow in immature white blood cells. There is an overproduction of these cells, which inhibits the production of normal blood cells. They can infiltrate other organs and normal bone marrow functions are taken over by the cancer cells.

If untreated, this cancer can be very aggressive and can kill someone very quickly. The disease peaks in childhood, decreases in risk in adolescence and adulthood, and then has a second peak in old age. Older people tend to be harder to treat and can have less positive outcomes but there is continuing research in this area to improve the chances of survival and decrease risk.

Treatments for ALL “There have been different lines of research and new therapies developed, such as immunotherapy (instead of chemotherapy, which is usually used to treat it). There is CAR-T Cell Therapy, which can

redirect the patients own immune system against the leukaemia by collecting T cells from the patients, engineering them to recognise a specific protein on cancer cells and injecting them back into the patient so they recognise those proteins and kill the cancer cells”, says Rives.

“There are also several medications which have proved effective against leukaemia, which have demonstrated better outcomes for the patients. These drugs can cause allergies, but there are new formulations being researched to reduce these allergic reactions. One new technology under investigation has a different formulation and is given inside red blood cells.”

This new technology is made up of red blood cells, which carry the encapsulated enzyme L-asparaginase. This enzyme depletes the important amino acid, asparagine, from the bloodstream and leads to starvation of the cancer cells. Unlike normal cells, cancer cells are often not able to produce this amino acid themselves and therefore depend on the blood supply of this nutrient.

The encapsulation within the

red blood cells protects the drug from degradation and reduces adverse effects of the enzyme, such as toxicity and allergic reactions.

“This treatment protects the patient from having an allergic reaction and while it is not yet approved, it is in the process of clinical trials”, continues Rives. “There are several options and different formulations of old drugs to reduce toxicity, which is always a big problem with high doses of a treatment.”

The road ahead Erytech are running clinical trials to test new developments and treatments for ALL in Europe. They have completed three clinical trials in which 100 patients with ALL have been treated with this new technology, including a multi-center, open-label Phase 2/3 pivotal trial in 80 children and adults with relapsed or refractory ALL. The safety and efficacy has been evaluated compared to freeform Lasparaginase derived from the bacteria E. coli, also known as native Lasparaginase.

“The trials are very successful.

The trials are improving every

time and it is improving for the older patients who are harder to cure as they tend to have a 30-40 per cent cure rate. There needs to be additional data obtained through the clinical trials.

“The results have been steadily improving and and the goal is to move from a 90 per cent cure rate in children to 100 per cent.

With new formulations, we might find that in the next decade, there will indeed be a 100 per cent survival rate.

“The goal is not only to cure patients and improve chances of survival but also to protect them from long term side effects, protect them from reactions and improve their quality of life, during their treatment and after their treatment.”

Read more on erytech.com

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Personalising therapy for blood clotting disorders

COLUMN

Professor Michael Laffan Professor of Haemostasis and Thrombosis, Honorary Consultant in Haematology, Faculty of Medicine, Imperial College London

Gene treatments on horizon for haemophilia

People with blood clotting disorders will gain maximum benefit from their therapy if it is tailored to their individual needs

By Tree Elven

By Ailsa Colquhoun

People with haemophilia lack an essential blood-clotting protein: we look at current treatments and latest advances.

“We spend a lot of time trying to correct the coagulation balance,” explains Professor Michael Laffan, Professor of Haemostasis and Thrombosis at Imperial College London.

Current treatment for haemophilia involves replacing the missing blood-clotting protein by intravenous injection.

“Intravenous treatment can be difficult to do at home,” says Prof Laffan, “especially for parents treating small children – and the effect does not last. Also, 15-20 per cent of patients treat the protein as foreign and respond by producing antibodies.

“An exciting, very new development in trials now, is a molecule that mimics the effect of the normal protein, eliminating the antibody problem. The treatment is subcutaneous, so it’s much simpler, and it lasts for a week or fortnight instead of a couple of days. We may see this licensed in the next year or two.”

There is also “cautious optimism” for the future of gene therapy, in which the protein-producing gene is introduced into the body, where it directs production of the protein, avoiding the need for injections.

Read more on healthawareness.co.uk

W

hen it comes to drugs, one size definitely does not fit all; a person’s age, gender, general state of health, weight and genetic make-up – even the climate they live in – these are all factors that can affect the way a person can react.

For haemophiliacs who need to receive regular infusions of blood-clotting drugs over many years, there are other considerations: the state of the patient’s veins, their levels of physical activity, how likely they are to bleed and when, and how willing they are to carry on with their treatment.

In haemophilia, where the patient has abnormal levels of clotting factors in their blood, the main aim of

treatment is to stop spontaneous, often cause-less bleeds, which can seep into the muscles and joints, causing damage, pain and immobility. Treatment to stop these bleeds before they start is known as prophylaxis. To be most effective, treatment should be given regularly in to a vein, perhaps, two to four times a week.

Although experts agree prophylaxis treatment should be tailored as far as possible to the individual’s needs – an approach known as pharmacokinetic (PK) or PK-guided prophylaxis – until now, treatment generally conforms to just prescribing within a recognised range of doses and frequencies of administration.

For many clinicians, the reason why PK has not been more widely

Move More, Be More Approximately 3,000 young people are thought to suffer from haemophilia in the UK. And yet, awareness of the impact of the condition, and what can be done to improve day to day living, is still very low.

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With proper treatment and self-care, most people with haemophilia can maintain an active, productive lifestyle. Just look at Little Bleeders founder and Professional Cyclist Alex Dowsett who is a severe Haemophiliac.

Despite suffering with haemophilia, Alex Dowsett has gone on to achieve great success in his career and will continue to offer support and guidance to children with haemophilia and their families. info@littlebleeders.com @littlebleeders Move More, Be More

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Haemophiliacs have abnormal levels of clotting factors in their blood and need to receive regular infusions of blood-clotting drugs over many years.

adopted is that it’s difficult to accurately take into account all the individual human and environmental factors that can affect the way a drug will work for a particular person. Dr Dan Hart, Consultant Haematologist at the Royal London Hospital’s haemophilia centre, explains: “PK has been covered in the literature for the past 20 years, but until now we’ve not had the software to enable clinicians to usefully recommend PK.”

Supporting PK in practice Thanks to the development of new, user-friendly IT platforms for PK, needing fewer patient blood tests, clinicians do now have the tools they need to offer more personalised therapy. For Dr Hart, being able to use

Dr Dan Hart Senior Lecturer in Haematology.

Immunobiology, Blizard Institute, Barts and The London School of Medicine and Dentistry, QMUL

this technology in practice is a useful medium for starting conversations with patients about a therapy that has a high cost to the health service: whether they are getting the right benefits and are taking the drugs as recommended. This is becoming especially important as new drugs come into the market. These could offer more prolonged protection, but these responses are likely to be even more varied between different patients and at different times of life, and will require greater thought about how to dose, he believes.

But Dr Hart says that people with blood clotting disorders can be a “conservative group”, adhering to the ‘if it ain’t broke, why fix it?’ school of thought. He adds that

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clinicians can also be sceptical about using new tools, particularly if they make consultations longer or require additional visits. However, he has been pleased at the positive response to PK discussions from many of his patients, often resulting in agreed, personalised changes to their prophylaxis prescriptions.

Dr Hart explains: “Although all clinicians feel a responsibility to make best use of expensive resources, a key question is always: how do I integrate this into daily practice?

“For me, though, PK prophylaxis is the logical thing to do. It offers benefits to the patient and to the broader health system, which achieves better use of these expensive drug resources.”

Our purpose is clear: to make a difference in the lives of those living with and affected by rare diseases and highly specialised conditions.

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NEWS

CAR-T cell therapy: repairing immune responses Trials with chimeric antigen receptors (CARs), which help repair the body’s own immune response, are delivering some ‘remarkable results’ in blood and other cancer treatments

By Tree Elven

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here’s increasing excitement over immunotherapy – using the body’s own immune system to combat cancer. Chimeric antigen receptors (CARs) form one approach that’s being developed.

“The whole field of immunotherapy is coming to the fore,” says Professor John Gribben, Chair of Medical Oncology at Barts. “Cancer cells are very effective at switching off the body’s immune system. In the blood, T cells can lose their ability to recognise cancer cells as foreign, or there aren’t enough to fight the cancer, or they’re ‘exhausted’ and not functioning properly.”

CAR-T cell therapy works by taking an antibody against a protein usually CD19 - on the surface of the cancer cell from the patient and structuring it onto the patient’s own T cells. “When the antibody latches onto the CD19, it sends a signal that makes the T cell think it’s seeing an antigen, so it’s armed to react.”

T cells are taken from the patient and sent to a laboratory for the manufacture of CAR-T cells which are genetically engineered to multiply, then infused back into the patient’s body to recognise and kill cancer cells.

“Real surprises” The treatment is not approved; it is still at trial stage, with most of the work being done in the USA, but it is delivering dramatic results, says Prof Gribben. He expects the U.S. Food and Drug Administration (FDA) to approve CAR-T cell therapy before Europe.

“The FDA has a ‘breakthrough therapy’ fast-track approval, which doesn’t exist here. There are three U.S. companies in particular, spinoffs of academic research, racing to get that. They’ll look to file in Europe after approval.”

We should refer to CAR-T cell studies ongoing in the UK, and Prof Gribben believes further trials here are imminent, by the end of this

Professor John Gribben Chair of Medical Oncology, Barts Cancer Institute

"The whole field of immunotherapy is coming to the fore."

year or the beginning of next, subject to regulation.

There are “some real surprises in what’s been seen in the trials.

Acute lymphoblastic leukaemia (ALL) in children is highly curable with chemotherapy, but you’re out of options after that. CAR-T has delivered remarkable results. The studies are small, but reasonable numbers. A trial with 24 lymphoma patients showed two-thirds in complete remission.”

Will CAR-T cell therapy replace chemotherapy?

That depends on the type of cancer involved, says Prof Gribben.

“With ALL, 90 per cent of kids can be cured with chemo - that’s a very high bar against going with an experimental treatment, no parent would contemplate it.

“You can’t just throw away a cure, but we have to think how to add to chemotherapy, how to work alongside it and eventually how to replace it. That will vary enormously from cancer to cancer.”

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CAR-T cell therapy augurs well for the future CAR-T cell therapy is rapidly emerging as one of the most promising approaches for treatment of refractory B-cell malignancies. CAR-T cells targeting CD19, initially evaluated at various academic centers, have shown remarkable efficacy in phase 1 and phase 2 trials in patients with aggressive and indolent B-cell leukemias and lymphomas that have failed all standard therapies. The promising results observed in the single institution studies led to licensing of these products to pharmaceutical companies that have initiated multicenter studies with the intent of obtaining approval from the Food and Drug Administration (FDA) and other registration authorities.

Side effects At least two multicenter clinical trials have recently been completed and showed that CD19 CAR-T cells induced remissions in more than 80 per cent of the patients with refractory leukemias and

lymphomas and greater than 50 per cent of them achieve complete remissions. Long-term remissions lasting more than five years have been observed on the early trials suggesting that CD19 CAR-T cell therapy is likely to cure a substantial proportion of these patients.

The therapy can be associated with two common side effects, cytokine release syndrome and neurological side effects, which usually occur within the first one to two weeks after the CAR-T cell infusion. Cytokine release syndrome is characterised typically by high fevers and flu-like illness. Drop in blood pressure, breathing difficulty, and organ dysfunction occur less commonly. Patients with neurological side effects are typically confused and disoriented for few hours to few days. While a few patients had fatal complications in the early trials with CAR-T cell therapy, there is now better understanding of the

under review by regulatory agencies in multiple countries and both physicians and patients eagerly await their decision.

Potential changes to cancer management

Sattva S Neelapu, MD Associate Professor and Deputy Chair ad interim, Department of Lymphoma and Myeloma, University of Texas

mechanism of these side effects and this has led to improved management strategies. Consequently, these side effects are now generally reversible and most patients are able to resume their normal activities, including returning to work, by four to six weeks. These extraordinary results from both of these multicenter trials are currently

If approved, CD19 CAR-T cell therapy is likely to usher in a new era and substantially change the management of B-cell leukemias and lymphomas in the future.

Moreover, CAR-T cell approaches against other targets such as CD22, CD30 and BCMA are also showing encouraging results in early trials and are likely to further improve outcomes not just in B-cell leukemias and lymphomas but also in patients with other cancers including Hodgkin lymphoma, T-cell lymphomas, and multiple myeloma.

Read more on healthawareness.co.uk

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INSPIRATION COLUMN

Dame Kelly Holmes Double Olympic Champion and Fundraiser for Myeloma UK

Dame Kelly Holmes: spreading awareness of myeloma “My mother, Pamela, was diagnosed with myeloma in 2015,” she says. “It was a huge shock that she was ill and that she had myeloma. It is not a well-known form of cancer, and our family knew little about it.”

My mother did not suspect it. “She had been suffering back pain and then two cracked ribs. A bone biopsy showed that her paraprotein levels were high, which can be an important sign of myeloma,” Dame Kelly says.

She praises her mother’s medical team, adding: ‘Everyone with myeloma responds to different drugs differently, so her doctors are working hard to find out which drugs suit her best. She has had two different types of treatment cycles of chemotherapy and steroids. She had responded at the beginning, but unfortunately the myeloma has come back, so more treatment must be tried.

Spreading the word Dame Kelly believes that telling the human stories behind myeloma helps raise awareness, and adds: “Myeloma does not have the word ‘cancer’ in its name, so people do not realise what it is.

We must get the word out to increase the rate of early diagnosis.

“With the right treatment, people with myeloma can live longer than they used to.

I’ve met some who have lived with it for a long time, which always brought hope to my family” she says.

Dame Kelly ran the 2016 London marathon for Myeloma UK and raises awareness and funds at her chain of coffee houses, called Café 1809, after her Athens Olympics running number. She says: “We must get the myeloma message out.”

Read more on myeloma.org.uk uk.virginmoneygiving.com/ KellysHeroesMyeloma

New push to reduce late diagnosis of myeloma

By Linda Whitney

New initiatives aim to increase early diagnosis of myeloma, the littleknown blood cancer that claims too many lives.

Myeloma is a cancer that lies low. Early symptoms are vague and myeloma has one of the highest rates of delay in diagnosis. Around a third of cases are diagnosed in A&E – one of the highest rates across all cancer types, and 30 per cent of those diagnosed as an emergency die within three months.

“Myeloma is an incurable but treatable blood cancer originating in the bone marrow. It presents GPs with a challenge,” says Dr Fenella Willis, Consultant Haematologist at St Georges Hospital London.

“It is relatively rare; only about 5,500 new cases are diagnosed annually. GPs may go years between seeing cases and the early symptoms are non-specific. Symptoms include pain (often in the back), fatigue and recurrent infections.

“Over half of myeloma patients visit their GP at least three times before diagnosis and one in five sees their GP five or more times before referral to a haematology consultant. Delayed diagnosis is associated with increased risk of complications such as bone disease and kidney failure.”

Yet, improved drugs – some with average response rates of over 80 per cent – and the use of stem cell transplantion, mean that many patients now have greatly improved prospects, provided they are

Dr Fenella Willis Consultant Haematologist, St George’s Hospital, London

Myeloma UK, has developed a new Myeloma Diagnosis Pathway: a tool to help primary healthcare professionals spot and act on suspicious symptoms.

diagnosed in a timely way and are fit enough to undergo such treatments.

Willis says: “20 years ago, three years was a positive outcome for a newly-diagnosed myeloma patient.

Today over a third can expect to live for 10 years or more, with longer disease-free intervals. Earlier diagnosis can save lives so the aim now is to raise awareness so more cases are diagnosed earlier.”

To help achieve this, the charity, Myeloma UK, has

developed a new Myeloma Diagnosis Pathway: a tool to help primary healthcare professionals spot and act on suspicious symptoms. “Once GPs suspect myeloma, they can use the national cancer diagnosis referral, so patients must be seen by a consultant haematologist within two weeks and, if diagnosed, start treatment within 62 days,” says Willis.

Myeloma UK has also set up a Myeloma Early Diagnosis Working Group, bringing together haematologists, immunologists, primary care researchers and GPs to identify the issues that lead to delayed diagnosis and define potential solutions and actions.

“We are looking at all aspects of the Myeloma Diagnosis Pathway, including improving communication between GPs, laboratories and consultant haematologists” says Willis.

This year’s Myeloma Awareness Week, from 2127 June, includes activities to highlight the importance of timely diagnosis and enhanced awareness.

There are signs that things are improving already. “The percentage of cases diagnosed in A&E is falling and early diagnosis rates are rising,” she says. “There is still work to do, but we are already seeing significant improvements.”

For more information about the Myeloma Diagnosis Pathway visit myeloma-academy. org.uk/mdp

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one

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BLOOD CANCER FACTS

137

different types and sub types

38,000

a year people diagnosed

One person is diagnosed

every 14 minutes

There are

230,000

people living with a blood cancer

Blood cancer is the

5th most common type of cancer

3

rd

most fatal cancer

Blood cancer is

the most common cancer in under 30s

SOURCE: BLOODWISE

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Finding kinder treatments for blood cancer

By Tree Elven

“There’s a lot of excitement in the field right now about the latest developments in blood cancer research and treatments,” says leading charity, Bloodwise.

“Overall, it’s about developing targeted therapies, down to the genetic and molecular level in individuals, and tailoring treatment,” says Diana Jupp, CEO of Bloodwise. “We need more treatments and less toxic treatments.”

The UK has an incredibly well-established blood cancer community and often leads international research ventures which in turn are informing new treatments in blood and other cancers, she says.

“Most people don’t realise blood cancer is the biggest cancer killer after lung and bowel. We’ve been improving outcomes since the 1960s and have greatly improved survival rates, but there’s a lot of work to be done now in making treatments less toxic as well as continuing to increase survival.”

While it’s easier to study the cancer because blood samples can be extracted, it’s very complex getting to the right information, says Jupp. “There might be different cells driving the cancer in the same sample, which affects the disease’s evolution and treatment. We found out in blood cancer first that cancer is very diverse.”

Diana Jupp CEO, Bloodwise

Trials, triumphs, tech At any given time, Bloodwise has over £90 million invested in research, and is currently funding over 1,000 researchers and clinicians involved in 200 active research projects.

Research will always be the leading focus, and “we want to help people affected right now by developing kinder treatments that improve patients’ quality of life,” says Jupp.

The use of targeted tyrosine kinase inhibitors (TKIs) has been a game-changer for patients with chronic myeloid leukaemia (CML): “What used to be a very aggressive blood cancer can now be managed with a single tablet. However, it’s not a cure, and many patients find side effects, like fatigue, prevent them leading an everyday life. TKIs don’t kill the cancer’s master cells, which although are only present in tiny amount, can constantly seed new CML cells.

A new programme targeting those cells has eradicated the disease altogether in mice. We

want to get it to clinical trials in people. In time, it could offer a cure for CML.” Anticipation is also high for the results of a trial focused on improving quality of life for CML patients by reducing their medication. One-year data suggests that people with CML who were responding well to their TKI were able to safely reduce TKI side effects by cutting their dose in half, and the vast majority did not see their CML return after cutting their dose. The two-year data from a current trial is due to be announced at the European Hematology Association conference at the end of June.

“Technology is playing an important role in our work: we have a new virtual platform that allows researchers easy access to CML patient samples. The childhood leukaemia cell bank is used to make important new discoveries about how leukaemia develops and has improved ways of managing the disease in children.

“I’ve been working in the cancer charity sector for over 20 years, and the progress in our understanding of cancer and our ability to treat it has been astonishing. The UK is a global leader in blood cancer research, and Bloodwise will continue to play a major role in developing new and innovative treatments.”

Read more on healthawareness.co.uk

“ My wife keeps me strong.

Research kept me alive.”

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Mark: Blood cancer survivor

Bloodwise. A company limited by guarantee 738089 Registered charity 216032 (England & Wales) , SC037529 (Scotland)

We know that research is the only way to beat blood cancer, which is why we’ve funded four out of five blood cancer researchers in the UK. Through research, we’ve increased survival rates and helped develop kinder treatments. Through research, Mark is still here.

Find out more at bloodwise.org.uk

The blood cancer research charity

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Myeloma is an incurable blood cancer originating in the bone marrow. Early diagnosis is vital because for patients, every day counts.

Myeloma UK is the only organisation in the UK focused solely on myeloma.

Visit www.myeloma.org.uk for more information.

Charity No: SC 026116

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