Ibrutinib Monotherapy Looks Good in Patients with CLL or SLL

Janssen Pharmaceutical has presented positive data from its RESONATE trial of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The data is being presented in full on June 3 at the American Society of Clinical Oncology (ASCO) meeting in Chicago and simultaneously published in a special edition of The New England Journal of Medicine.

RESONATE

RESONATE is an international, multicenter Phase 3 trial in 391 patients with relapsed or refractory CLL or SLL. Patients received either oral ibrutinib once daily, or ofatumumab administered intravenously.

Monotherapy ibrutinib was found to significantly lengthen progression-free survival (PFS) and overall survival (OS) compared with ofatumumab.

Ibrutinib is an investigational compound within a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors.

PFS was the primary endpoint of the RESONATE study, with OS, overall response rate (ORR) and safety as key secondary endpoints.

The results demonstrated the superiority of ibrutinib monotherapy in this patient population which is notoriously difficult-to-treat, and it did so regardless of baseline disease characteristics.

Specifically, 43 percent of ibrutinib patients achieved a partial response (PR) compared to only four percent of patients taking ofatumumab.

"These results add to the body of clinical data demonstrating the value of ibrutinib in previously treated CLL patients," said Jane Griffiths, Company Group Chairman of Janssen Europe, the Middle East and Africa (EMEA). "These are the first Phase 3 data for ibrutinib. We're pleased to see the strong hazard ratios for progression-free and overall survival and are encouraged that many patients continue to do well on treatment with ibrutinib."

Source: PR Newswire