Janssen and Pharmacyclics’ ibrutinib has demonstrated a significant and sustained progression-free and overall survival benefit in patients with previously untreated chronic lymphocytic leukaemia (CLL), according to new long-term results shared by the Johnson & Johnson company.
Affecting approximately 4.92 per 100,000 people every year in Europe, CLL is typically a slow-growing blood cancer of the white blood cells.
Despite patient outcomes improving significantly over the last few decades, CLL is still characterised by consecutive episodes of disease progression and patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
Administered orally once daily, ibrutinib is designed to block the BTK protein needed by normal and abnormal B-cells to multiply and spread.
The drug already holds approvals to treat treatment-naïve and pretreated CLL, as well as certain patients with mantle cell lymphoma and Waldenström’s macroglobulinaemia.
The phase 3 RESONATE-2 trial has been comparing ibrutinib monotherapy against chlorambucil for up to 12 cycles in previously untreated CLL patients aged 65 years and older.
The results, presented at this year’s European Hematology Association Congress, showed a median progression-free survival of 8.9 years in the ibrutinib arm versus 1.3 years in the chlorambucil cohort.
With up to ten years of follow-up, median overall survival had not been reached with ibrutinib and 27% of patients in the study remained on ibrutinib.
The drug was also found to be well tolerated as a long-term treatment and no new safety signals were observed.
Commenting on the latest results, clinical study investigator, Alessandra Tedeschi, Niguarda Hospital, said: “When ibrutinib was first introduced more than ten years ago, it changed the course of CLL treatment, and today it remains a central part of the standard of care for patients living with B-cell malignancies.
“The final analysis of the RESONATE-2 study confirms the favourable benefit-risk profile of ibrutinib is sustained over time, with the longest follow-up data of any targeted therapy in CLL, and demonstrates its potential to enable patients diagnosed with CLL today to look forward to the possibility of a normalised life expectancy.”