The results of a phase 3 study pave the way for the use of ibrutinib as front-line therapy in patients with chronic lymphocytic leukaemia, experts say.
The RESONATE-2 study presented at the 2015 ASH Annual Meeting this week found ibrutinib (Imbruvica) reduced the risk of death by 84% compared to chlorambucil in treatment-naïve elderly patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
The results published simultaneously in The New England Journal of Medicine also showed a 2-year overall survival (OS) rate of 98% with ibrutinib compared to 85% for patients on chlorambucil.
“The ibrutinib data represent some of the most compelling results I’ve seen during my career. These data may change how we clinicians treat patients with CLL or SLL in the frontline setting,” said lead study investigator Jan Burger from The University of Texas MD Anderson Cancer Center.
“The results showcase the clinical utility of ibrutinib in this setting and the value it may bring as an appropriate treatment option for these patients.”
In another study also presented at the conference and published online in The New England Journal of Medicine a phase 1 trial of venetoclax showed the potential of BCL2 antagonism as an additional therapeutic avenue for patients with relapsed CLL.
Responses appeared to be more durable among those who had a complete response than among those with a partial response, reported the researchers including Andrew Wilson from the Department of Clinical Haematology and the Bone Marrow Transplantation Unit, Royal Melbourne Hospital.
Gradual dose escalation appeared to minimise the risk of the tumour lysis syndrome, the major toxicity associated with venetoclax.
RESONATE-2 was funded by Pharmacyclics, an AbbVie Company. The venetoclax study was supported by by AbbVie and Genentech.