Ibrutinib Continues to Improve Survival in Chronic Lymphocytic Leukemia

Janssen and Pharmacyclics' ibrutinib has shown a notable and lasting benefit in both progression-free and overall survival for patients with untreated chronic lymphocytic leukaemia (CLL), based on new long-term findings from Johnson & Johnson.

CLL, a slow-progressing blood cancer affecting white blood cells, impacts about 4.92 per 100,000 individuals annually in Europe. While patient outcomes have significantly improved over the last few decades, CLL continues to be marked by recurring disease progression. Patients frequently require multiple lines of therapy as they experience relapses or develop resistance to treatments.

Ibrutinib, taken orally once daily, works by inhibiting the BTK protein, which is crucial for the proliferation and spread of both normal and abnormal B-cells. The drug is already approved for treating both treatment-naïve and previously treated CLL, as well as for certain cases of mantle cell lymphoma and Waldenström’s macroglobulinaemia.

The phase 3 RESONATE-2 trial has been evaluating ibrutinib monotherapy against chlorambucil for up to 12 cycles in previously untreated CLL patients aged 65 years and older. The findings, presented at the European Hematology Association Congress, revealed a median progression-free survival of 8.9 years for patients on ibrutinib, compared to just 1.3 years for those on chlorambucil. After up to ten years of follow-up, the median overall survival for patients treated with ibrutinib had not been reached, and 27% of the study participants continued on ibrutinib therapy.

Furthermore, ibrutinib was found to be well-tolerated over the long term, with no new safety concerns emerging. Alessandra Tedeschi of Niguarda Hospital, a clinical investigator in the study, noted that ibrutinib revolutionized CLL treatment over a decade ago and continues to be integral to the standard care for patients with B-cell malignancies. Tedeschi stated, "The final analysis of the RESONATE-2 study confirms the sustained favourable benefit-risk profile of ibrutinib over time, offering the longest follow-up data of any targeted therapy in CLL, and showing its potential to provide patients diagnosed with CLL today the possibility of a normalised life expectancy."

The positive long-term outcomes associated with ibrutinib underscore its significance in the therapeutic landscape of CLL. The ability to provide sustained disease control and improved survival rates positions ibrutinib as a crucial option for CLL treatment, offering hope for better-managed disease and improved quality of life for patients.