A dual combination therapy significantly improves outcomes for patients with chronic lymphocytic leukaemia (CLL), according to interim findings from a British-led study.
Details of the findings were reported in the New England Journal of Medicine and at the conference of the European Haematology Association in Milan, Italy.
The FLAIR trial has been testing the combination of ibrutinib and venetoclax as a treatment, guided by personalised blood tests. It included 786 patients at 96 centres in the UK, all receiving treatment for the first time. 260 of these received the dual therapy, while another 263 received ibrutinib alone and 263 received chemotherapy.
The researchers say the answer to the question of whether the treatment is better than chemotherapy is a “resounding yes”.
After five years, 93.9% of patients who received the ibrutinib and venetoclax combination were alive with no disease progression – compared with 58.1% on standard chemotherapy, and 79% on ibrutinib alone.
The researchers report that 66.2% of patients on ibrutinib and venetoclax had no detectable cancer in their bone marrow after two years. No patients who received only ibrutinib achieved this milestone.
Study leader Dr Talha Munir, consultant haematologist at Leeds Teaching Hospitals, 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.”
Dr Iain Foulkes from Cancer Research UK, which funded the study, 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.”
Source:
Munir T, Girvan S, Cairns DA, Bloor A, Allsup D, Varghese AM, Gohil S, Paneesha S, Pettitt A, Eyre T, Fox CP, Forconi F, Balotis C, Pemberton N, Sheehy O, Gribben J, Elmusharaf N, Gatto S, Preston G, Schuh A, Walewska R, Duley L, Webster N, Dalal S, Rawstron A, Howard D, Hockaday A, Jackson S, Greatorex N, Bell S, Stones D, Brown JM, Patten PEM, Hillmen P; UK CLL Trials Group. (2025) “Measurable Residual Disease–Guided Therapy for Chronic Lymphocytic Leukemia.” New England Journal of Medicine, 15 June 2025, doi: 10.1056/NEJMoa2504341.
Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2504341
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