Personalised drug treatments have outperformed chemotherapy for leukaemia patients in a trial led by Leeds researchers.
Newly published long-term results of the UK-wide FLAIR trial could transform treatment for chronic lymphocytic leukaemia (CLL), the most common form of leukaemia in adults.
Personalising the way that cancer medicine is given is crucial to reduce the burden of treatment for patients and their loved ones.
Researchers from Leeds Teaching Hospitals NHS Trust and the University of Leeds found that a combination of two targeted drugs - ibrutinib and venetoclax - with treatment guided by personalised blood tests - offers significantly better outcomes than standard chemotherapy.
The results of the trial, which are published in the New England Journal of Medicine and presented at the European Haematology Association conference in Milan, show that this treatment leads to better survival, fewer long-term side effects, and the possibility of life without chemotherapy for many patients.
CLL is a rare blood cancer that affects around 3,800 people in the UK each year, most of whom are over the age of 40. Symptoms can include persistent illness, weight loss, swelling, fatigue and anaemia (where there are not enough red blood cells in the blood).
The trial was coordinated by the Leeds Cancer Research UK Clinical Trials Unit (CTRU) and led by Dr Talha Munir at Leeds Teaching Hospitals NHS Trust. It was sponsored by the University of Leeds, with funding from Cancer Research UK, AbbVie, and Johnson & Johnson.
David Cairns, Professor of Clinical Trial Research and Director of Late Phase Trials in the Cancer Division at CTRU, was scientific lead on the study. Professor Cairns said: “Personalising the way that cancer medicine is given is crucial to reduce the burden of treatment for patients and their loved ones. At the Leeds Cancer Research UK Clinical Trials Unit, one of our core aims is to find smarter, kinder treatments - and the results of the FLAIR trial are a prime example of this.
“Without patients taking part in clinical trials, life-changing research like this would not be possible.”
Dr Talha Munir, Consultant Haematologist at Leeds Teaching Hospitals NHS Trust said: “FLAIR trial is a milestone. We have shown that a chemotherapy-free approach can be not only more effective but also more tolerable for patients. By tailoring individualised treatment based on how well the cancer responds, we’re moving into an era of truly personalised medicine.”
The FLAIR trial's findings suggest that patients can now receive more targeted treatments that not only extend survival but improve quality of life.
We’re hopeful that the results of the FLAIR trial will power new treatment options for leukaemia and other blood cancers, thanks to the efforts of researchers in Leeds and across the UK working together on this trial.
This part of the FLAIR trial followed 786 people with previously untreated CLL across 96 centres in the UK. It tested whether newer drugs designed to target cancer cells more precisely than chemotherapy could lead to longer remission and fewer complications. The answer was a resounding yes.
After five years:
- 93.9% of patients who received ibrutinib plus venetoclax were alive with no disease progression
- This compares to 79.0% for those on ibrutinib alone and 58.1% for those on standard chemotherapy (FCR)
- 66.2% of patients on the new combination had no detectable cancer in their bone marrow after two years, vs. 0% on ibrutinib alone and 48.3% on chemotherapy.
The trial represents a successful partnership between NHS hospitals, universities, and the pharmaceutical industry — all working together to deliver hope to patients across the UK.
Dr Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK, said: "The results of the FLAIR trial show that we can provide kinder, more targeted treatment for chronic lymphocytic leukaemia, which gives people with CLL more precious time with their loved ones.
"We’re hopeful that the results of the FLAIR trial will power new treatment options for leukaemia and other blood cancers, thanks to the efforts of researchers in Leeds and across the UK working together on this trial.”
Catherine’s story: From bleeding gums to breakthroughs
Image: Catherine in her garden. Credit: Catherine Whitfield
When Catherine Whitfield, a 63-year-old from Farnley, West Yorkshire, started noticing symptoms such as bleeding gums, constant illness and neck pain, she never imagined it would lead to a cancer diagnosis. However, taking part in a groundbreaking clinical trialhas helped reshape the way chronic lymphocytic leukaemia (CLL) is treated, not just for her, but for patients around the world.
And for Catherine, it meant getting her life back. She said: “After three years of treatment, I am still MRD negative. That means no cancer cells. I feel well, I’m back in the garden, and I’m still doing the farm accounts and the books for a local electrician.”
Catherine’s story is at the heart of this success. Diagnosed in 2018, she joined the trial after discussing it with clinicians at Leeds.
Catherine said: “I’d lost my husband to cancer. I have seen how hard it could be. My first thought after my diagnosis was, I will never see my grandchildren being born and growing up. But the way this trial was explained — it just made sense. Also, the thought of chemotherapy was scary to me. The trial felt right. And it was. Now I have two grandchildren, Drew and Alaia and they are a delight and highlight the joys of a healthy life.”
While chemotherapy had once been the mainstay of CLL treatment, Catherine was spared its harsher side effects.
“I thought bone marrow biopsies would be the worst, but even that was okay. The team explained the FLAIR trial so clearly. I felt supported, informed and hopeful. They were all brilliant — Dr Peter, Dr Tal, the nurses — every step was clear, and I felt completely supported. I believe the trial has been a success and I am grateful to the team,” she added.
Dr Talha Munir added: “This isn’t just about data. It’s about people like Catherine, and thousands of others, who trusted us with their care. Thanks to them, we’re changing the future of cancer treatment.”
Further information
Email University of Leeds Press Officer Mia Saunders at m.saunders@leeds.ac.uk with media enquiries.
Top image: Adobe Stock.