Janssen-Cilag reports long-term follow-up data from Phase III RESONATE-2 trial of Ibrutinib to treat CLL


Janssen-Cilag has reported positive long-term follow-up results from its Phase III RESONATE-2 trial of Ibrutinib to treat chronic lymphocytic leukaemia (CLL).

Ibrutinib has been developed as bruton's tyrosine kinase (BTK) inhibitor, which forms a strong covalent bond with BTK to prevent transmission of cell survival signals within the malignant B-cells.

Following the inhibition of BTK protein, ibrutinib helps in killing and reducing the number of cancer cells, thereby delaying cancer's progression.

The ongoing RESONATE-2 trial is a Pharmacyclics-sponsored, randomised, multi-centre, open-label, Phase III study including 269 treatment-naïve patients with CLL aged 65 or older in the EU, the US and other regions.

"Following the inhibition of BTK protein, ibrutinib helps in killing and reducing the number of cancer cells, thereby delaying cancer's progression."

During the study, the patients were randomised to be orally administered with ibrutinib 420mg on a once-daily basis until progression or unacceptable toxicity, or chlorambucil on day one and 15 of each 28-day cycle for up to 12 cycles.

A five-year follow-up data suggested that the patients treated with ibrutinib experienced 89% of overall response rate (ORR) with 14% of patients achieving complete responses (CR).

UC Irvine Health Chao Family Comprehensive Cancer Center clinical science associate director Susan O’Brien said: “These longer-term results demonstrate that ibrutinib can help patients keep chronic lymphocytic leukaemia in a complete or partial remission for an extended period of time, through five years, without chemotherapy.

“In addition, these data results indicate the time without disease progression is longer for patients when treatment with ibrutinib is started as early as possible in the course of the disease.”


Image: Ibrutinib in capsule form. Photo: courtesy of Janssen-Cilag International NV