NICE (National Institute for Health and Care Excellence) has announced that a treatment for advanced breast cancer that started its life in Cardiff more than 10 yeas ago, has been approved for use by the NHs in England and Wales.
“It is fantastic news that the results of the FAKTION trial have now resulted in NICE approval, meaning that British breast cancer patients will now be able gain access to capivasertib through the NHS,” said Professor Rob Jones, Co-Chief Investigator FAKTION trial and Associate Medical Director for RD&I at Velindre Cancer Centre
“FAKTION was led from Cardiff and showed that patients with cancer containing one or more of three biomarkers could expect to double their life span if capivasertib was added to their hormone therapy. These findings were then confirmed in a larger Phase 3 trial and the results from both trials have been crucial in gaining the NICE approval.
“When a patient has been diagnosed with metastatic cancer, patients are often most concerned about how much time they have left. While we're not able to offer a cure, this new medicine will buy people additional really important time they can spend with their families and friends.”
The Phase I FAKTION clinical trial sponsored by Velindre began in 2014 and the results showed that we could safely combine standard hormone therapy with AstraZeneca’s AKT inhibitor capivasertib.
The next step was a Phase II trial which closed in 2018, that showed that patients who received the combination treatment could expect to have their cancer controlled and live for twice as long as those receiving hormone therapy alone. AstraZeneca were excited by the FAKTION trial results and started a Phase III global trial which confirmed the FAKTION findings and led to the USA’s Federal Drug Agency (FDA) licensing the drug treatment for use in patients with ER positive, HER2 negative advanced breast cancer in June 2023. Approvals followed in 2024 from the European Medical Agency and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with NICE approval needed to enable NHS patients to receive the treatment.
The University of Leeds have had a publication accepted by the Oncolibrary cautioning the use of IO (Penbrolizumab, Nivolumab, Ipilimumab etc) in elderly frail population. Incidence of serious toxicities is not higher in this group, but the actual impact in terms of survival, QOL, hospitalisation is significantly higher. More than the age, it is the frailty factor that influences adverse outcomes. An Onco-Geriatric assessment at baseline is rcommended.
The full paper can be accessed via this link: https://oncodaily.com/oncolibrary/immune-checkpoint-inhibitor-associated-toxicities254339
Sky news have published a news article on the TARGET National trial called 'Life-saving' simple blood test could transform and personalise cancer care if trial succeeds.
The article talks about how the 'liquid biopsy' that could transform cancer treatment, with the goal being to personalise cancer care across the NHS - saving lives and making treatment less risky and intrusive.
To access the article please click the following link: https://news.sky.com/story/life-saving-simple-blood-test-could-transform-and-personalise-cancer-care-if-trial-succeeds-13313872
Claire Bryant, Velindre University NHS Trust Research Service's Research Facilitator had a poster abstract accepted for the Wales Cancer Research Conference that just took place on 03 March 2025.
The title of the abstract is 'Accelerating cancer research: the hidden power of the Research Facilitator' - Turning the red tape into greenlights - faster trials, better patient outcomes'.
The poster was received at the conference.
A Velindre Cancer Centre patient has become the first from Wales to participate in the APPROACH clinical trial, which is investigating the potential benefits of proton beam therapy for people with brain tumours. Led by researchers at the University of Leeds, the trial focuses on patients with oligodendroglioma, a type of brain tumour.
Bethan Thomas who joined the trial shared her experience: "Being part of the trial meant even if I was randomised to receive radiotherapy, I would be closely monitored with regular visits with the consultant and regular scans for five years. Proton beam therapy isn’t widely available to everybody, and it certainly isn’t available in Wales so to have the potential to take part in the trial and have the best treatment, it was a bit of a no brainer for me!”
Standard brain radiotherapy for oligodendroglioma can cause long-term side effects, including memory issues and difficulties processing information. Proton beam therapy, an advanced form of radiotherapy, targets tumours more precisely, sparing healthy brain tissue and potentially reducing side effects.
The trial, patients are randomised into two groups: one receiving standard radiotherapy and chemotherapy, and the other receiving proton beam therapy and chemotherapy. Researchers, including Velindre co-investigator Dr James Powell, will evaluate side effects, quality of life and survival rates over five years.
"This innovative trials has the potential to significantly improve care for patients with this type of brain tumour," said Dr James Powell. Funded by the National Institute for Health and Care Research (NIHR) and Medical Research Council (MRC), the APPROACH trial represents an exciting step forward in advancing cancer care.
Velindre is also involved in the HIT-Meso trial, exploring proton beam therapy for lung cancer, demonstrating its commitment to cutting-edge research.
Velindre Cancer Centres has become the first site in the UK to recruit patients to the Cardiff-led BICCC study, a clinical trial investigating a novel approach to improving disease-free survival for first patients in the UK to BICCC, a new colorectal clinical trial aimed at increasing disease-free survival.
Colorectal cancer is one of the leading causes of cancer-related deaths worldwide. In the early stages of the disease, many patients can be cured with surgery. However, in the later stages, the cancer can return or progress even after surgery and chemotherapy. One potential way of preventing relapse is by making the patient’s immune system better at detecting and destroying any cancer cells that might remain after removal of the cancer.
The Brief Intervention with Cyclophosphamide in patients with Colorectal Cancer who completed treatment (BICCC) trial aims to test whether giving a low dose of cyclophosphamide - a chemotherapy drug - can enhance the immune system's ability to detect and destroy any remaining cancer cells after surgery and chemotherapy. The study focuses on stage 2 - 4 colorectal cancer patients and is being conducted across 10 UK sites including Cardiff and Swansea.
Participants are randomly assigned to either standard care (active monitoring) or a four-week cyclophosphamide treatment spread over nine weeks. The primary goal is to assess whether the drug improves disease free survival by kick-starting T cell activity against cancer cells. Recruited participants will be seen or sometimes phoned five times over the course of 13 weeks for monitoring and to receive their randomised treatment in the form of a tablet they take at home, with three years follow up.
Professor Rob Jones, Consultant in Medical Oncology and Associate Medical Director for RD&I at Velindre University NHS Trust said:
“We have recruited five patients to this new Cardiff-led study, the first UK site to recruit. It has been great working with Professor Andy Godkin in the past and we hope this trial will be equally as successful as our previous collaboration. Patients in the previous study tolerated treatment very well with minimal side effects. Hopefully this trial will demonstrate a brief intervention following definitive standard treatment will lead to additional patients who are cured."
Professor Andy Godkin, the Chief Investigator from Cardiff University and Cardiff and Vale University Health Board added:
“It has been a fairly long campaign to get this trial off the ground, and thanks to everyone for their patience, and for Cancer Research Wales for sticking with it. Velindre Hospital has led the way, being the first of 10 centres to open, and having already recruited several patients. Heartfelt thanks to Rob Jones and all the staff at Velindre, and of course, the patients.”
The study is funded by Cancer Research Wales and represents an important step forward in colorectal cancer care.
As part of Lung Cancer Awareness Month, Velindre Cancer Centre proudly highlights its role in the groundbreaking HIT Meso clinical trial, a Phase 3 study exploring the use of proton beam therapy to treat pleural mesothelioma. This incurable form of lung cancer affects the membrane surrounding the lungs, often caused by asbestos exposure in industries like shipbuilding, construction and steel production.
Dr Paul Shaw emphasised, “If successful, proton beam therapy could become an upfront treatment option for patients with MPM. For certain patients, this might provide a new standard of care treatment that not only extends life, but also enhance the quality of life for people living with this condition.
BioNTech's UK cancer research has gained attention through a significant collaboration with Health and Care Research Wales, aiming to pioneer mRNA-based cancer treatments and position Wales at the forefront of innovative cancer care.
Following its COVID-19 vaccine success, BioNTech's expanded efforts focus on personalised cancer immunotherapies that adapt to each patient's unique tumour profile. Velindre is currently running multiple studies within this initiative, including BNT122-01, BNT113 and BNT327-01. Addition studies, BNT116-01 and BNT326 are in the process of being set up, expanding the Trust's research portfolio to encompass mire cancer types and therapeutic approaches. This growing research programme highlights Velindres's dedication to bringing new cancer therapies to patients in Wales, emphasising personalised care and novel treatments.
The growth of this partnership continues to mark a significant development for Wales and the mission to support high-quality research that impacts patient lives and advances global cancer treatment strategies.
The BioNTech research portfolio, specifically the BNT116-01 that is currently in set up in Velendre, has been highlighted in a recent BBC news story. Further details can be found at: https://www.bbc.co.uk/news/articles/ce806ndv8neo
In May 2024 representatives from Velindre went to the European Association of Palliative Care 13th World Research Congress in Barcelona to talk about their research.
Dr Elin Harding, the first Palliative Care Research Fellow at Velindre Cancer Centre showcased her research process on the acceptability of QR Code wristbands for palliative care patients. The project aims to find a solution to information sharing between specialists and emergency healthcare professionals to improve patient care and reduce unwanted or avoidable hospital admissions. The first stage of the project was find out if the proposed system - an electronic palliative care QR code wristband system - was acceptable to palliative patients, both with malignant and non-malignant conditions. The study found that patients were very positive about the system and therefore we are working towards the next stage which involves working with the Welsh Ambulance Service Trust (WAST) to understand what content and format they would find useful to aid their care and decision making in an emergency situation.
Dr Stephanie Sivell - newly appointed Palliative Care Non-clinical Research Fellow at Velindre Cancer Centre and Marie Cancer Research Centre in Cardiff University - gave an insightful presentation on her previous work on Serenity, a European-funded programme by HORIZON, led by Professor Simon Noble (Cardiff University) and Prof. FA Klok (Leiden University, Netherlands). Dr Sivell presented work from the third work package of Serenity about understanding the views of patients and clinicians on anti-thrombotic therapy in advanced cancer and pragmatic ways to work with the research team across four countries (Denmark, France, Spain and the UK). Further results from the analyses were also presented in two posters at the conference by colleagues in the Marie Curie Research Centre at Cardiff University (Elin Baddeley). Velindre have been key in recruiting patients to this international study.
The QuicDNA project, a ground-breaking initiative aiming to improve lung cancer diagnosis in Wales, was recently spotlighted in a video by Life Sciences Hu Wales as part of a new series on cancer innovations. Developed at Velindre Cancer Centre, QuicDNA seeks to revolutionise the detection and treatment of lung cancer through liquid biopsies, enabling faster, minimally invasive testing via blood samples. this approach could shorten diagnostic timelines and enhance patient outcomes, especially critical for Wales where lung cancer remains a leading cause of cancer mortality.
Ina a heartfelt interview, Velindre patient Craig Maxwell, whose fund raising has been instrumental in supporting QuicDNA, shared his journey. Diagnosed with terminal lung cancer in 2022, Craig launched a dedicated campaign raising close to £1 million through events such as a walk and cycle along the Wales Coast Path. This effort, supporting the Maxwell Family Genomics fund in collaboration with Velindre Cancer Charity, exemplifies Craig's mission to improve cancer services for future patients. "Craig's contributions are both unique and inspiring," said Professor Tom Crosby, underscoring the transformative impact of Craig's dedication. The interview can be found at https://www.youtube.com/watch?v=hMQk5uhirtY
The project was also recently honoured with the prestigious Moondance Cancer Award for 'innovation and improvement'. QuicDNA lead, Dr Magna Meissner praised the project's success and the collaboration of academia, industry and patient advocated.
Four years ago, Bryan Webber was patient number one on the head and neck cancer clinical trial PEARL at Velindre Cancer Centre. Today he is using his experience of cancer diagnosis, treatment and clinical trials to support the next generation of dentists. Bryan is a retired dentist, working in the NHS for 50 years, the last 30 years in a training role. He is passionate about giving dental trainees a better understanding of the part they can play in early detection of cancer, as well as the problems patients experience as a result of their cancer treatment. Bryan has volunteered to talk all over Wales and has even been to Leeds to talk to 150 newly graduated dentists.
Bryan said: “When I started treatment for my cancer, I decided to post some pictures on Facebook to show my friends what was happening to me. I posted pictures of my mouth and palate, the ulcers that developed, my MRI and PET scans, everything! My dental friends were fascinated and soon I was being invited to come and tell my story to various groups in the dental sector, including dental students."
"Early diagnosis is vital to successful cancer treatment and dentists are in the right place to notice changes in their patients’ mouth. And then when they refer a patient to see their GP, that is the end of it usually – they don’t see what happens after that.
In June 2024, ITV filmed with Bryan as he talked about how he is helping dental students and graduates to recognise cancer and to understand witha the patient goes through when they are in treatment. The news story screened on ITV Wales at Six and is available in ITV's web articles at https://www.itv.com/news/wales/2024-07-04/the-dentist-using-his-cancer-diagnosis-to-teach-others-how-to-spot-the-signs which also covers the PEARL clinical trial that Bryan took part in.
Feedback on his presentations has been overwhelmingly positive and he is keen to keep combining his professional expertise with his personal cancer story to ensure the dentists of the future are equipped to help with early detection of oral cancers.
Bryan still has side effects from his cancer – lack of saliva making some foods difficult to digest, inability to taste his favourite red wine and as Chairman of the Cardiff Male Voice Choir his voice has dropped and he’s now one of the lowest of the low in hitting the bass notes. While some of the side effects are permanent, Bryan says he can live with them because he is still here, four years on.
In addition to this work in his professional community, Bryan continues to advocate for the patient as a patient representative on Velindre’s Senior Leadership Group and RD&I sub-committee.