by A phase 3 trial conducted by the University of Leeds has discovered that personalized treatment for chronic lymphocytic leukemia (CLL), the most common form of adult leukemia, leads to longer survival rates and a higher chance of remission for patients. The trial, titled “Chronic lymphocytic leukemia therapy guided by measurable residual disease,” was published in the New England Journal of Medicine and presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego.
This personalized approach resulted in significant improvements in both progression-free survival and overall survival for patients with previously untreated CLL. The effect was particularly noticeable for patients with poor outcomes from standard treatments, such as those with certain genetic mutations.
In the trial, adult patients were given a combination of cancer growth-blocking drugs for varying durations, depending on how rapidly their disease responded. The results showed that this approach significantly improved progression-free survival and overall survival compared to the standard treatment for CLL, with more than 19 out of 20 patients achieving remission three years after starting treatment.
The trial, named FLAIR, is a phase 3 randomized controlled trial conducted in over 100 hospitals across the UK. Lead author Professor Peter Hillmen from the University of Leeds’ School of Medicine and Leeds Teaching Hospitals NHS Trust stated, “Our findings show that, for this group of patients, the treatment is very effective at tackling their disease and is well tolerated by them. This means that patients on our trial had better outcomes while also enjoying a better quality of life during their treatment. Most patients treated with the new combination have no detectable leukemia in their blood or bone marrow by the end of treatment, which is better than with previous treatments and is very encouraging.”
Dr. Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK, expressed his enthusiasm for the results, stating, “We are delighted to see these results from the FLAIR trial which show the importance and effectiveness of tailoring cancer treatment to the individual patient. Not only this, but the trial has found a way to do so without requiring frequent bone marrow tests which are more invasive and can be painful.”
Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. While it is not usually curable, it can be managed with treatment. Current treatment options include chemotherapy, immunotherapy, and cancer growth blockers. The FLAIR trial specifically focused on testing the effectiveness of cancer growth blockers Ibrutinib and Venetoclax (I+V), also known as Imbruvica and Venclexta, respectively. These drugs are typically administered continuously or for a fixed duration instead of being tailored to each patient’s response. This approach may result in patients either stopping treatment too early or continuing treatment for longer than necessary, increasing the risk of relapse and side effects.
The FLAIR trial aimed to determine whether personalized treatment duration based on regular blood sampling and/or bone marrow monitoring was as effective or better than standard treatment. Regular blood tests and bone marrow sampling allowed researchers to assess patients’ response to I+V treatment in real-time, enabling them to adjust the treatment duration accordingly. The trial found that basing treatment duration on less invasive blood samples was just as effective as using bone marrow samples, which can be painful and require sedation.
The FLAIR trial, which began in 2014 and recruited 1,509 patients with CLL, compared two groups of patients. One group received I+V treatment, while the other received the standard treatment known as FCR. At the end of this stage of the trial, 87 patients on FCR experienced disease progression, compared to only 12 on I+V. Additionally, 25 patients treated with FCR died during the trial, compared to only nine treated with I+V.
The research team hopes that this personalized therapy approach, guided by blood test monitoring, will become the new standard of care for patients requiring first-line CLL treatment. Professor Hillmen stated, “The results of the FLAIR Trial are exceptional and herald a change in the way chronic lymphocytic leukemia will be treated. FLAIR has been a huge collaborative effort over the last decade by the UK’s leading CLL specialists and by the hematology teams in over 100 hospitals throughout the UK.”
The trial was coordinated by the Leeds Cancer Research UK Clinical Trials Unit, which aims to improve the length and quality of survival for cancer patients worldwide. Professor David Cairns, Deputy Director of the unit, emphasized the importance of building evidence to identify the correct treatment, duration, and patient population. The success of the FLAIR trial was made possible through the participation of clinicians, scientists, methodologists, and dedicated trial participants and their families.
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1. Source: Coherent Market Insights, Public sources, Desk research
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